QA Associate III — Second Shift (GMP & CAPA)

PCI TRGR Penn Pharmaceutical Services Ltd; San Diego (CA); On-site; USD 40,845 - 45,956; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) plan

Paid time off

Job summary

PCI Pharma Services in San Diego is seeking a QA Associate III to support GMP operations on the second shift. You will perform QA activities, assist with investigations, batch disposition, and review documentation to ensure cGMP compliance.

Responsibilities include audits support, writing procedures, updating ERP lot statuses, and coordinating with production for compliant batch release. Bachelor’s in Life Sciences preferred with 3–5 years in QA/manufacturing. Competitive benefits offered.

Qualifications

• Minimum of 3–5 years of GMP experience in documentation, QA on the floor, manufacturing, or equivalent.
• Knowledge of cGMP regulations and good documentation practices.
• Strong organizational and analytical skills.
• Proficiency with Microsoft Office.

Responsibilities

• Assist with audits and regulatory inspections.
• Generate and compile lot file review documentation for batch disposition.
• Review and approve production batch records and controlled documents.
• Support investigation activities related to quality events.
• Maintain equipment inductions and change controls.
• Prepare procedures and SOPs.
• Update lot status in ERP.

Skills

GMP compliance

cGMP regulations

Quality investigations

Documentation control

ERP systems

Microsoft Office

Batch record review

Education

Bachelor’s degree in Life Sciences

Tools

ERP system

Documentation management software

Job description

PCI Pharma Services in San Diego is seeking a QA Associate III to support GMP operations on the second shift. You will perform QA activities, assist with investigations, batch disposition, and review documentation to ensure cGMP compliance.

Responsibilities include audits support, writing procedures, updating ERP lot statuses, and coordinating with production for compliant batch release. Bachelor’s in Life Sciences preferred with 3–5 years in QA/manufacturing. Competitive benefits offered.