QA Operations Lead

System One; Pennington (NJ); On-site; USD 62,000 - 69,000; Full time

Benefits offered by this job

Health, dental, vision benefits

401(k) plan

Life insurance

Spending accounts

Voluntary plans

Job summary

System One is seeking a QA Operations Lead for an onsite, contract-to-hire role in Pennington, NJ. The role focuses on day-to-day quality oversight of warehouse and manufacturing operations to ensure GMP and regulatory compliance.

You will lead deviation management, real-time quality decisions, and floor-level training to sustain quality across production areas. The ideal candidate has 3–5 years in GMP settings, strong knowledge of warehouse and manufacturing operations, and experience with

Qualifications

• Minimum 3–5 years in GMP environment with manufacturing/warehouse quality oversight.
• Strong knowledge of warehouse and manufacturing operations for real-time quality decisions.
• Experience in biotech startup environments is preferred.

Responsibilities

• Provide day-to-day quality oversight of warehouse operations including receipt, storage, sampling and disposition ensuring GMP compliance.
• Oversee on-floor manufacturing quality, including in-process checks and batch review.
• Lead deviation initiation, containment actions and triage with Manufacturing and Warehouse teams.

Skills

GMP knowledge

Quality oversight

Manufacturing ops

Audit experience

Regulatory compliance

Education

Bachelor's degree or equivalent experience

Tools

MasterControl

Job description

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