Quality Assurance Coordinator in San Fernando, California at Puretek Corporation

Quality Assurance

QA Supervisor / QA Manager

PureTek Corporation – Arroyo and Nelson Facilities

The Quality Assurance Coordinator is responsible for supporting GMP manufacturing operations through independent quality oversight, batch record review, line clearance verification, in-process inspection, documentation compliance, deviation escalation, and audit-ready execution of Quality Systems activities across pharmaceutical, OTC drug, dietary supplement, and cosmetic operations.

This role is intended for experienced GMP professionals capable of operating independently in a fast-paced FDA-regulated manufacturing environment. The position requires strong working knowledge of 21 CFR Parts 210, 211, and 111, Good Documentation Practices (GDP), ALCOA+ data integrity principles, and batch disposition support activities.

The QA Coordinator serves as a key quality representative on the production floor and is expected to proactively identify compliance risks, escalate quality events, and support continuous GMP inspection readiness.

• Perform QA line clearance, startup approval, and in-process verification activities for manufacturing and packaging operations
• Monitor manufacturing operations for compliance with approved Master Batch Records, SOPs, GMP requirements, and safety procedures
• Review executed batch production records for completeness, accuracy, and GDP compliance
• Verify material usage, reconciliation, labels, status identification, and equipment cleanliness
• Ensure compliance with 21 CFR Parts 210/211, 21 CFR Part 111, GDP, and ALCOA+ principles
• Initiate or support deviation reports and investigations related to GMP events
• Support implementation and follow-up of CAPA activities
• Maintain inspection readiness and support FDA, NSF, SQF, customer, and third-party audits
• Coordinate with Manufacturing, Packaging, Warehouse, QC, and Regulatory teams
• Reinforce GMP and documentation compliance expectations on the production floor

• Bachelor’s degree in Chemistry, Biology, Pharmacy, Microbiology, Food Science, or related scientific discipline preferred
• Equivalent GMP manufacturing quality experience may be considered

• Minimum 3–5 years of QA experience in pharmaceutical, OTC drug, dietary supplement, or cosmetic manufacturing
• Experience with batch record review, line clearance, GMP floor oversight, documentation review, and audit readiness
• Experience in a CDMO/CMO environment preferred

• Strong knowledge of cGMP requirements, GDP practices, and ALCOA+ principles
• Understanding of batch manufacturing and packaging operations
• Ability to independently identify and escalate GMP risks
• Strong organizational, communication, and documentation review skills
• Ability to work effectively in fast-paced manufacturing environments

• Ability to stand and walk for extended periods within manufacturing environments
• Ability to wear required PPE and gowning
• Ability to occasionally lift up to 25 pounds

• Batch review accuracy
• Documentation Right-First-Time performance
• Line clearance effectiveness
• GMP observation reduction
• Deviation response timeliness
• Audit readiness performance
• Training compliance and escalation effectiveness