Adv. Manufacturing

Description: Job Purpose: Secondary Packaging Maintenance Technicians are responsible for repairing, maintaining, troubleshooting issues on the Packaging machines and documenting all work while adhering to all safety procedures. Essential Duties and Responsibilities: Perform preventative maintenance on automated packaging lines Ensuring procedures are followed when performing maintenance. · Perform electrical and mechanical maintenance on fully automated equipment. · Ability to troubleshoot a variety of equipment and problem solving skills · Use time management wisely and effectively · Maintain and /or repair of conveyors, gear boxes, motors, inkjet printers, sensors and robotics. · Daily production line walkthroughs to ensure problems are caught before production demands are jeopardized. · Complete On the Job Training in a timely manner · Ability to follow cGMP’s and good documentation practices. · Communicate with a daily pass down to other members of maintenance, production and management Requirements: Education/ Experience: · High school diploma or 2 years minimum of electrical or mechanical maintenance in a manufacturing/production environment. · Knowledge of the Pharmaceutical Industry preferred · Must pass a Drug Test. · Must speak, write, and read English. · Specific expertise, skills and knowledge within maintenance gained through education and experience. · The ability to take strategic objectives and accept accountability to drive results through effective actions. · The ability and willingness to change direction and focus to meet shifting organizational and business demands. · The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.

Benefits: 401(k) Competitive salary Dental insurance Health insurance Paid time off Parental leave Relocation bonus Job Description Seeking a mid- to senior-level Mechanical Engineer, Senior Mechanical Designer, or Engineer in Training (EIT) with knowledge of mechanical systems and HVAC design. Key Responsibilities Design and develop HVAC and mechanical systems for building projects. Prepare mechanical drawings and layouts using AutoCAD and Revit. Perform heating and cooling load calculations. Review blueprints, specifications, and engineering documents. Coordinate mechanical designs with other engineering disciplines. Prepare equipment schedules, calculations, and technical documentation. Ensure design accuracy and compliance with project requirements. Requirements Experience with mechanical systems and HVAC design. Proficiency in AutoCAD, Revit, Excel, and Word. Familiarity with Carrier Block Load or Trane TRACE. Strong technical, analytical, and communication skills. Benefits Overtime paid at 1.5x. Employer-paid health insurance after 60 days. Retirement plan with 3% company match after one year. PTO accrual after 180 days.

JLL empowers you to shape a brighter way. Our people at JLL are shaping the future of real estate for a better world by combining world class services, advisory and technology for our clients. We are committed to hiring the best, most talented people and empowering them to thrive, grow meaningful careers and to find a place where they belong. Whether you’ve got deep experience in commercial real estate, skilled trades or technology, or you’re looking to apply your relevant experience to a new industry, join our team as we help shape a brighter way forward. Chief Engineer – JLL What this job involves: As Chief Engineer, you'll lead our engineering team to deliver exceptional building performance while ensuring complete operational reliability for our clients. This critical leadership role combines hands-on technical expertise with strategic team management, where you'll oversee all building systems operations, maintain our 100% uptime commitment, and protect client assets through proactive maintenance programs. You'll serve as the technical authority and client advocate, driving safety excellence, regulatory compliance, and continuous improvement initiatives that maximize building value. This is an opportunity to make a direct impact on facility performance while developing and leading a high-performing engineering team in a dynamic commercial real estate environment. What your day-to-day will look like: Monitor and maintain critical building systems including HVAC, refrigeration, boilers, and mechanical/electrical equipment while overseeing comprehensive preventive maintenance programs Supervise engineering and maintenance staff through hiring, training, performance management, and daily work coordination to ensure operational excellence Ensure Critical Facility Work Authorization (CFWA) compliance among staff, tenants, and contractors while managing all contractor activities and vendor relationships Conduct equipment inspections, execute monitoring programs, and continuously evaluate maintenance methods to improve reliability and efficiency Identify safety hazards, implement remediation plans, and administer safety training programs while ensuring Federal, State, and Local regulatory compliance Manage client relationships through formal and informal meetings, measuring satisfaction and addressing feedback to deliver exceptional service Maintain infrastructure documentation, inventory management, and adequate supplies to support seamless building operations Required Qualifications: 7+ years of progressive experience in building operations and maintenance with strong knowledge of HVAC, refrigeration, boiler, and mechanical/electrical systems 3+ years of supervisory experience managing engineering and maintenance teams, including hiring, training, and performance management Experience with commercial building systems, critical facility operations, and Critical Facility Work Authorization (CFWA) processes Demonstrated knowledge of preventive/predictive maintenance methodologies and building automation systems Understanding of Federal, State, and Local regulatory compliance requirements and safety program implementation Excellent communication and relationship management skills with proven ability to interface with clients, contractors, and executive leadership Bachelor's degree in engineering, Facilities Management, or related technical field preferred Preferred Qualifications: Professional Engineering (PE) license or facilities management certifications (CFM, FMP, SFP) HVAC, electrical, or mechanical systems certifications and/or project management certification (PMP) Experience with critical facilities such as data centers, hospitals, or laboratories Knowledge of energy management programs, sustainability initiatives, and computerized maintenance management systems (CMMS) Building automation expertise and experience with predictive maintenance technologies Understanding of building commissioning processes and performance optimization strategies Experience with vendor negotiations, contract management, and budget oversight Location: Hopkins, SC Work Shift: 08 Hour Day - 1st Shift/Morning Shift This position does not provide visa sponsorship. Candidates must be authorized to work in the United States without sponsorship. Location: On-site –Hopkins, SC, Seneca, SC If this job description resonates with you, we encourage you to apply, even if you don’t meet all the requirements. We’re interested in getting to know you and what you bring to the table! Personalized benefits that support personal well-being and growth: JLL recognizes the impact that the workplace can have on your wellness, so we offer a supportive culture and comprehensive benefits package that prioritizes mental, physical and emotional health. Some of these benefits include: 401(k) plan with matching company contributions Comprehensive Medical, Dental & Vision Care Paid parental leave at 100% of salary Paid Time Off and Company Holidays Early access to earned wages through Daily Pay At JLL, we harness the power of artificial intelligence (AI) to efficiently accelerate meaningful connections between candidates and opportunities. Using AI capabilities, we analyze your application for relevant skills, experiences, and qualifications to generate valuable insights about how your unique profile aligns with the specific requirements of the role you're pursuing. JLL Privacy Notice Jones Lang LaSalle (JLL), together with its subsidiaries and affiliates, is a leading global provider of real estate and investment management services. We take our responsibility to protect the personal information provided to us seriously. Generally the personal information we collect from you are for the purposes of processing in connection with JLL’s recruitment process. We endeavour to keep your personal information secure with appropriate level of security and keep for as long as we need it for legitimate business or legal reasons. We will then delete it safely and securely. For more information about how JLL processes your personal data, please view our Candidate Privacy Statement. For additional details please see our career site pages for each country. For candidates in the United States, please see a full copy of our Equal Employment Opportunity policy here. Jones Lang LaSalle (“JLL”) is an Equal Opportunity Employer and is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process – including the online application and/or overall selection process – you may email us at HRSCLeaves@jll.com. This email is only to request an accommodation. Please direct any other general recruiting inquiries to our Contact Us page > I want to work for JLL. Accepting applications on an ongoing basis until candidate identified.

JOB PURPOSE The Pre-Assembly Technician will be responsible for the hammering of the taper pins in the Front sight base along with the complete assembly of the AR -15 upper. The position will require a close working relationship with inventory to notify of any problems or defects in the materials while also working alongside drillers to ensure quality is being met; maintaining blemished uppers and small parts that make up the upper itself. DUTIES AND RESPONSIBILITIES Complete assembly of AR-15s Hammer taper pins in front sight base Read product orders to ascertain proper upper and barrel. Ensures the proper upper and assembly parts are being used with each order. Comply with all safety rules and regulations. Maintain personal protective equipment. All other duties, as assigned. QUALIFICATIONS Required Qualifications include: High school diploma or equivalent Ability to read product orders and recognize the proper upper and barrel. Ability to properly use basic hand tools. Excellent communication and ability to work effectively and efficiently in a team environment. Patience, Persistence, and problem-solving skills are very important. Very high attention to detail Works in a timely fashion. Preferred Qualifications include: Ability to assemble and disassemble AR-15 upper preferred. Manufacturing experience WORKING CONDITIONS Work is performed in an operational manufacturing warehouse environment. Specific job assignments may require day, evening, weekend, or holiday hours. Overtime may be required to meet production needs. PHYSICAL REQUIREMENTS Team members are constantly standing, walking, carrying, pulling/pushing, bending, seeing, kneeling, stooping, reaching, hearing, using hand and power tools, as well as handing paperwork. Team members will be lifting objects weighing 50 lbs. or less regularly. DIRECT REPORTS Not Applicable. Must be at least 18 years of age. Export Control Compliance Notice This position may involve access to technology or software source code subject to U.S. export control laws (ITAR/EAR). Employment is contingent on verifying U.S. Person status or obtaining any necessary export license/confirming the availability of a license exception. Applicants must provide information for export control screening, which will be reviewed for compliance. Palmetto State Armory may elect not to pursue a license or exception and may decline to proceed with an applicant on that basis.

Geotechnical Project Engineer Requisition Number: 2026-1610-07 Build Your Career. Own Your Future. At S&ME, you're more than just an employee, you're an employee-owner of a 100% employee-owned company that has been solving complex geotechnical, civil, environmental, and construction materials testing challenges for over 50 years. We're invested in your success and offer a career path with growth opportunities, training, and hands-on experience. Join a team that values safety, integrity, and teamwork while offering industry-leading benefits designed to help you thrive - on and off the job, including but not limited to: Medical, dental & vision plans with HSA and FSA options 100% Employee Stock Ownership Plan (ESOP) with a minimum 5% company contribution 401(k) with employer match PTO with rollover Maternity/Parental leave Tuition reimbursement Company vehicle & fuel card for project-based work Employee recognition & credential incentive programs $2,000 referral bonuses and more! Your Role: Hands-On, Impactful, and Fast-Paced As a Geotechnical Project Engineer you will be supporting work across our Columbia, South Carolina, and Augusta, Georgia offices. You will manage and contribute to geotechnical engineering assignments from initial planning to final delivery, using engineering expertise to address site-specific and subsurface challenges. You will collaborate with project managers, field personnel, laboratory staff, and clients to evaluate technical findings, prepare engineering solutions, and produce accurate reports for a variety of infrastructure and construction projects in both the public and private sectors. This position combines technical problem-solving, project management support, and client communication, with opportunities to expand your skills and advance your career while working with an experienced geotechnical team. What You'll Do: Project Management & Coordination: Assist with leading geotechnical projects by organizing subsurface investigations, field activities, and laboratory services while maintaining project timelines, budgets, and deliverables. Geotechnical Evaluation & Recommendations: Interpret soil, rock, and groundwater conditions to provide engineering guidance for foundation systems, grading, pavement design, and site development. Engineering Reports & Deliverables: Develop technical reports, engineering calculations, and design guidance that present project results, potential concerns, and key assumptions to clients and internal teams. Communication & Project Support: Partner with project managers, field crews, subcontractors, and clients to resolve technical issues, respond to site changes, and keep project activities on track. Staff Development & Safety: Provide guidance to less-experienced team members while supporting workplace safety, technical quality, and continued professional growth. What We're Looking For: You have a Bachelor's degree in Civil, Geotechnical, Mining, or a related engineering field You have a minimum of 4 years of related geotechnical engineering experience, which preferably includes some extent of project management responsibilities You have a Professional Engineer (PE) license or the ability to obtain within 6 months of hire What to Expect: With the use of Company-provided Personal Protective Equipment (PPE). Outdoor, hands-on work in all weather conditions Walking over rough terrain and standing for long periods (up to 12 hours) Lifting and carrying 40-50 lbs. of materials and equipment Safely handling field tools and maneuvering equipment on active construction sites Why Join S&ME? At S&ME, your career growth matters. You'll receive professional training, work on exciting projects, and be part of a company that truly invests in its people. This is more than a job; it's a chance to build a long-term career in the engineering and construction industry. Ready to Get Started? Apply today and take the first step toward an exciting future with S&ME! This full-time role offers competitive pay based on experience. Candidates must comply with our Fleet Management, Substance Policy, and Reference Check requirements. Only candidates with valid employment eligibility (I-9) will be considered. Visa assistance is not available. S&ME reserves the right to hire internally or externally at any time. No candidate/recruiter calls, personal calls, or walk-ins are accepted.

Dominion Energy is committed to providing reliable, affordable, and increasingly clean energy that powers our customers every day. If you want to work for a purpose-driven company that values safety and collaboration, we’re looking for you. You won’t just find a job here; you’ll find your career. Review the position below and apply today. We offer a hybrid work schedule (one week in the office, one week of teleworking) to accommodate the need for flexibility. Military service members and veterans with ranks from E5-E9, W1-CW5, or O3-O6, plus appropriate equivalent combination of education and years of experience as outlined below will be considered for this opportunity. At this time, Dominion Energy cannot transfer or sponsor a work visa or employment authorization for this position. This position does not offer relocation assistance. Job Summary The Senior Infrastructure Engineer is responsible for the design, implementation, administration, and support of enterprise Windows server environments. This role provides advanced technical expertise in Windows platforms, system lifecycle management, patching, security compliance, and automation, while serving as a key contributor to infrastructure reliability and operational excellence. This position operates with a high level of independence, providing leadership in troubleshooting complex issues, driving process improvements, and supporting critical business and regulatory requirements. Key Responsibilities Windows Systems Administration Administer and support enterprise Windows Server environments (2016/2019/2022 and above). Manage Active Directory, Group Policy, DNS, and core infrastructure services. Ensure system stability, performance, and availability across production environments. Patching & Configuration Management Lead Windows patching lifecycle using SCCM/MECM and enterprise patching tools. Coordinate monthly patch cycles, remediation, and exception handling. Maintain patch compliance reporting and support audit requirements. Advanced Troubleshooting & Operations Diagnose and resolve complex system, application, and infrastructure issues. Support incident response, root cause analysis, and service restoration. Provide escalation support for critical outages and performance issues. This opportunity can be based in Richmond, VA; Innsbrook, VA; or Cayce, SC. Required Knowledge, Skills, Abilities & Experience 7+ years of hands-on experience with Windows Server administration. Strong expertise in: Active Directory & Group Policy SCCM / MECM / Patch Management tools System troubleshooting and root cause analysis Experience supporting enterprise-scale environments with high availability requirements. Strong communication and customer service skills. Education Requirements Education Level: Degree or an equivalent combination of education and demonstrated related experience may be accepted in lieu of preferred level of education: Bachelor Preferred Discipline(s): Business Administration, Computer Engineering, Computer Science Other disciplines may be substituted for the preferred discipline(s) listed above. Working Conditions Office Work Environment 76 -100% Travel Up to 25% Export Control Certain positions at Dominion Energy may involve access to information and technology subject to export controls under U.S. law. Compliance with these export controls may result in Dominion Energy limiting its consideration of certain applicants. What You'll Get Expected Hiring Base Salary Range: $90,900 - $118,100 The expected hiring base salary range is the range we anticipate hiring within for this position. The actual salary offered may vary based on factors such as the selected candidate’s qualifications, skills, experience, and work location. This is not intended to represent the full salary range for the position or limit future compensation growth. At Dominion Energy, we offer excellent plans and programs for employees. Employees are rewarded with a competitive salary and comprehensive benefits package which includes: health, dental, and vision benefits with coverage for families and domestic partners, vacation, retirement plans including 401k contributions and matches, paid holidays, tuition reimbursement, bonus eligibility, sick leave, and disability insurance. To learn more about our benefits, click here: dombenefits.com. Dominion Energy is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin and/or status as a protected veteran or individual with a disability. You can experience the excitement of our company – it's the difference between taking a job and starting a career.

Desktop & Windows Engineer SME *ND3 Inc.* · Washington, DC (on-site) *Job Type:* Full-time, Contract · *Pay:* [$XX – $XX per hour / year] · *Clearance:* Secret (must be able to obtain) *About the Role* ND3 Inc. is seeking an experienced Desktop & Windows Engineer to serve as a subject matter expert supporting the Executive Office for United States Attorneys (EOUSA) Enterprise Operations, Platforms, and Solutions (EOPS) team. In this role, you will design, test, and deploy enterprise Desktop Operating System (OS) images and software packages that support U.S. Attorneys' Offices nationwide. What You'll Do * Develop, test, and implement Windows 11 desktop OS images for large-scale enterprise deployment. * Engineer deployment solutions using Microsoft Endpoint Configuration Manager (MECM/SCCM), Microsoft Deployment Toolkit (MDT), OSD, Autopilot, and Intune. * Build, test, and deploy software distribution packages and application updates for desktops, laptops, tablets, and servers. * Implement automated server OS build and deployment processes. * Support OS patching infrastructure (HCL BigFix, Windows Update/MECM) to apply mandatory security updates. * Automate tasks, reporting, and troubleshooting with PowerShell and VBScript. * Analyze, evaluate, and recommend desktop, laptop, tablet, and server hardware. * Perform security tasks including vulnerability scan review, patch management, assessment support, auditing, and documentation. * Provide recommendations to meet user-based software requirements. What You'll Bring *Required* * Bachelor's degree in computer science, business, or a related field, *or* 10 years of relevant work experience in lieu of a degree. * Deep knowledge of Windows 11 internals, architecture, and configuration. * Expertise with Active Directory, Group Policy (GPO), OU structure, and domain services. * Strong experience with imaging and deployment tools (MDT, SCCM/MECM, MECM OSD, Autopilot, Intune). * Proficiency with PowerShell scripting for automation, reporting, and troubleshooting. * Experience with device management, compliance policies, configuration profiles, and Windows Update for Business. * Knowledge of endpoint security (BitLocker, Defender for Endpoint, application control, privilege management), patch management, and vulnerability remediation. * Understanding of enterprise networking fundamentals (DNS, DHCP, VPN, certificates). * Experience managing drivers, firmware, hardware standards, and lifecycle management. * Experience supporting virtualization (VDI, Hyper-V) and monitoring/logging tools (Event Viewer, Log Analytics, SIEM). * Programming experience in C# and/or Visual Basic with strong .NET knowledge. *Preferred* * Advanced PowerShell skills, including building modules and automating enterprise-scale workflows. * Cloud endpoint management experience (Intune, Azure AD/Entra ID, Conditional Access, Defender for Endpoint). * Expertise with modern provisioning (Autopilot, ESP customization, scripted deployments). * Familiarity with Zero Trust endpoint principles and secure configuration baselines. * Understanding of PKI and enterprise certificate management. * Advanced Windows troubleshooting with ProcMon, WinDbg, symbols, and performance analyzers. Security Requirements * U.S. citizenship and compliance with the DOJ Residency Requirement are required. * Must be able to obtain and maintain a Secret clearance (Background Investigation required; may be required to hold up to Top Secret). Work Location On-site at 175 N St. NE, Washington, DC 20530 *or* 1600 Hampton Street, Columbia, SC. Government-furnished equipment is provided. Schedule * Full-time, Monday to Friday _ND3 Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, protected veteran status, or status as an individual with a disability._ Pay: $1.00 - $100.00 per year Benefits: * 401(k) * 401(k) matching * Dental insurance * Health insurance * Life insurance * Paid time off * Professional development assistance * Tuition reimbursement * Vision insurance Work Location: In person

The Manufacturing Production Supervisor is responsible for overseeing daily production activities, ensuring production schedules and backlogs are met, maintaining appropriate staffing levels, and supporting a safe, efficient, and productive manufacturing environment. Maintains workflow, address barriers, and optimizes manufacturing performance with regard to lean manufacturing, safety, and efficiency. Manages production operator employees by delegating workloads, managing performance, coaching, scheduling, and performance management. Job Responsibilities: Monitors and maintains workflow for assigned production lines. Partners with other Team Leads to manage product flow between all production departments. Communicates with production team on daily productivity goals, statuses, potential barriers, safety concerns, and other pertinent daily metrics/data. Maintains open communication with other leadership within operations and other departments and communicates changes as needed; documents occurrences as needed. Collaborates with Production Unit Managers and Plant Manager for updating and implementing changes to standard work documentation. Upholds standard work practices, and documents as needed. Monitors teams schedule for PTO requests, LOA, and ensures staffing levels to meet production demands. Upholds policy and procedures among team members and administers corrective actions as needed. Coaches team members on performance and partners with leadership and HR as needed for potential changes to roles, promotions, and terminations. Fills in on production floor as needed to support operational needs. Reflects company mission, vision, and values through professional conduct. Supervisory Responsibilities: Production Operators for assigned processes, and schedules. Minimum Qualifications: High school diploma or equivalent. Five (5) or more years in team-based manufacturing experience. Three (3) or more years of management experience. One (1) or more years of training/coaching experience. Proficient with SAP. Effective verbal and written communication skills. Strong sense of urgency, and ability to take action. Strong time management skills. Tactful and professional manner. Willing to work 12-hour night shifts, weekends, and holidays. (2-2-3 Rotation) Preferred Qualifications: Associate degree or higher-level degree in applicable field. Forklift Operators Certification. Continuous Improvement certification. Three (3) or more years of experience in cable manufacturing experience.

*$17.00+ per hour | Full-Time | Urgently Hiring* 120 Glassmaster Road, Lexington, SC 29072 Monday – Friday | 8:00 AM-5:00 PM (1-hour lunch break) *Position Overview:* We are seeking a dependable and detail-oriented *Warehouse Upholstery Associate* to join our *manufacturing and production team*. This role is responsible for measuring, verifying, and preparing upholstery components while supporting efficient production flow and maintaining high-quality standards throughout the manufacturing process. The ideal candidate is safety-conscious, organized, and comfortable working with upholstery materials, adhesives, hand tools, and production equipment in a fast-paced warehouse or manufacturing environment. *Essential Responsibilities:* * Measure and inspect *upholstery parts and components* to ensure accuracy and quality standards are met * Verify dimensions, specifications, and materials before production and assembly * Safely operate *glue adhesive equipment and application tools* in ventilated work areas * Use *power tools, pneumatic tools, and hand tools* safely and efficiently * Monitor and maintain inventory levels of *foam, wood, hardware, and upholstery materials* * Record material usage, production details, and quality concerns accurately * Support upholstery, warehouse, and production operations as needed * Maintain a clean, organized, and safety-compliant work environment * Follow all company safety procedures and standardized manufacturing processes * Perform all other duties as assigned *Physical Demands:* * Lift, carry, push, and/or pull 1-50 lbs. frequently * Squat/kneel, bend/stoop, crawl, twist/turn, grasp, and reach overhead and outward frequently * Sit, stand, and walk for 1-10 hours per day * Work in a fast-paced industrial environment wearing hearing protection, eye protection, steel-toed shoes, and other appropriate protective clothing *Requirements:* * Experience in *upholstery, warehouse operations, manufacturing, or production work* preferred * Ability to use *hand tools, pneumatic tools, and power tools* safely * Strong attention to detail and commitment to product quality * Ability to work independently and as part of a team * Comfortable working in a *fast-paced manufacturing environment* * Reliable attendance and strong work ethic Expected hours: 40.0 per week Benefits: * 401(k) * 401(k) matching * Dental insurance * Health insurance * Life insurance * Paid time off * Vision insurance

Job Purpose: The purpose of the Batch Record Review (BRR) role is to ensure that all manufacturing and packaging processes comply with regulatory standards, company policies, and quality requirements before product release. This role plays a critical part in maintaining product integrity, patient safety, and regulatory compliance by verifying that production records are complete, accurate, and meet Current Good Manufacturing Practices (cGMP) and other industry regulations (e.g., FDA, ISO). By meticulously reviewing batch documentation, identifying deviations, and ensuring corrective actions are taken, the BRR role helps prevent product defects, recalls, and compliance issues, ultimately safeguarding public health and maintaining company credibility. Essential Duties and Responsibilities: Oversee status of batches through disposition/release process and remove barriers, communicate escalations as appropriate. Performs final batch disposition of finished drug product and combination product batches, to ensure high quality medicine (cGMP Compliance) is released within expected metrics to ensure timely release to market. Performs review checklist to verify all requirements have been performed and meet requirements. Collaborates within Manufacturing to resolve batch record discrepancies or errors as it relates to Good Documentation Practices (GDP). Review documentation for manufacturing activities associated with commercial, development, and engineering execution in accordance with good documentation practices, including but not limited to executed batch records, master batch records, and product specific documents. Independently executes batch record review for completeness, accuracy and cGMP compliance. Support the evaluation and lot disposition of drug product. Critically review various documentation types to ensure completeness, accuracy and compliance including but not limited to test methods, method validation protocols and reports and Standard Operating Procedures (SOPs). Contributes to process improvement of batch records and associated processes (e.g. turnaround times) to ensure all Quality Assurance (QA) batch disposition deadlines are met. Responsible for the review and approval of cGMP documentation against SOPs in order to ensure compliance in Manufacturing processes. Raise deviations as needed in order to capture potential impacts to product quality. Communicate significant quality risks that may impact product suitability or regulatory compliance in a timely manner to Executive Management. Work with colleagues to instill a sense of ownership and commitment to quality. Provide technical support to the leadership team in the decision-making process. Supplemental Functions: · Performs and maintains archiving of all batch documentation to include copying, scanning, and filing. Revise or review standard operating procedures and submit procedural changes as needed to meet local, Global and Regulatory requirements. Keep abreast of industry developments, forthcoming regulations, guidance, best practices, etc for all Scientific Areas. Performs and assists with additional work duties or responsibilities as assigned or apparent. Job Specifications and Qualifications: Knowledge & Skills: Comprehensive knowledge of quality system requirements such as US FDA, cGMP, GCP, EMA, and ICH guidelines and has a proven track record of successfully implementing these requirements to ensure patient safety and compliance with FDA and other applicable health authorities’ requirements. Competent in Microsoft Word and Excel. Knowledgeable in Adobe Acrobat (PDF) advanced features and workflows. Familiar with document management software, including SharePoint. Excellent written and oral communication skills. Team player and must be able to interact with all departments. Ability to work independently and be dependable. Technical writing skills required. Strong attention to detail. Specific expertise, skills, and knowledge within Quality Assurance gained through education and experience. The ability and willingness to change direction and focus to meet shifting organizational and business demands. The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition. The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals. The ability to manage a multitude of resources and to be accurate and current with data and information. Education/Experience: BS degree preferred with at least 1 year of experience in a regulated cGMP Environment. In lieu of degree, at least 4 years of equivalent experience in pharma manufacturing operations considered and strong background in GDP. Working Conditions / Physical Requirements: This position requires bending, typing, lifting (up to 40 1bs.), vision (20/20). Standing (10%), sitting (80%) and walking (10%) throughout the facility.