QA Operations Lead

Job Title: QA Operations Lead
Location: Pennington, New Jersey
Type: Contract To Hire
Compensation: $45.00/hour to $50.00/hour
Work Model: Onsite – onsite
Hours: 40.0 hours per week

Responsibilities

• Provide day-to-day quality oversight of warehouse operations, including receipt, storage, sampling, and material disposition activities, ensuring GMP and regulatory compliance.
• Provide quality oversight of manufacturing operations on the floor, including in-process checks, line clearance, and real-time review of batch execution.
• Serve as the lead point of contact for real-time deviation identification, initiation, and triage on the floor; direct immediate containment actions in partnership with Manufacturing and Warehouse personnel.
• Coach and provide directions to Manufacturing and Warehouse personnel on deviation initiations, document corrections, and quality expectations.
• Escalate quality-critical issues, trends, and risks from the floor to the Quality Operations Manager and relevant stakeholders in a timely manner.
• Review completed GMP records (production records, cleaning records, warehouse records, etc.).
• Lead and participate in assigned compliance activities (compliance walkthroughs, GEMBA, etc).
• Manage updates to GMP SME Lists for Inspections.
• Lead Deviation, support, and triage activities on Manufacturing and Warehouse issues.
• Perform other Quality Operations support, including sustained Quality on the Floor presence across warehouse and manufacturing areas.
• Participate in and help facilitate quality-related training workshops.
• Other duties as assigned.

Requirements

• Minimum of 3-5 years within the GMP industry, including demonstrated experience providing quality oversight in a manufacturing and/or warehouse environment.
• Strong working knowledge of warehouse and manufacturing operations sufficient to provide real-time quality oversight and decision-making.
• Experience with biotech startup environments is preferred.
• Able to communicate system implementation status and floor-level quality issues to senior leadership.
• Able to provide clear, confident direction to manufacturing and warehouse personnel during real-time quality events.
• Able to work professionally and productively in both open office and production floor environments.
• Internal and external audit experience preferred.
• Master Control experience preferred.
• Must be able to sit, stand, and walk on the production floor for long periods of time.
• Bachelor's degree preferred in Life Science, Science, or a Regulatory-related field, and/or equivalent experience.

System One, and its subsidiaries including Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

#M3

Ref: #558-Scientific