Senior QA Associate — GMP Compliance & Documentation

PCI TRGR Penn Pharmaceutical Services Ltd; San Diego (CA); On-site; USD 41,000 - 46,000; Full time

Benefits offered by this job

Paid time off

Health insurance (dental & vision)

Flexible spending account

401(k)

Job summary

PCI Pharma Services is seeking a QA professional to support GMP operations, audits, and documentation review. This role ensures a compliant cGMP environment and contributes to batch disposition documentation.

The ideal candidate has strong organizational and analytical skills, knowledge of cGMP and GMP documentation practices, and experience with investigations, CAPAs, and change controls.

Qualifications

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

Responsibilities

• Assists in regular follow ups with end users to ensure timely completion of open investigations and investigation activities.
• Assist in ensuring the adequacy of investigations performed in relation to manufactured drug product and drug substance to support the batch release process.
• Provides quality support in the review and approval of quality reports including deviations, OOSs, complaints, OOTIs, SCARs, and CAPAs.
• Generates and compiles lot file review documentation for batch disposition.
• Updates lot status in ERP system.
• Responsible for equipment inductions, revisions and record maintenance within the electronic database.
• Performs Technical Quality review of validation protocols and reports.
• Performs logbook documentation audits for cGMP regulated logs and SOPs.
• Creates, revises and approves procedures.
• Performs the review of equipment and facility related Change Control documentation.
• Assists with internal, client and regulatory audits.
• Assists with the generation of department metrics.
• Assists with developing recommendations for continuous improvement projects.
• Assists in the review and approval of production batch records and associated data for product disposition.
• Assists in the review and approval of controlled documents including standard operating procedures, protocols, and reports.

Skills

GMP experience

Documentation

Organizational skills

Analytical skills

Education

Bachelor’s degree in Life Sciences

High School Diploma or equivalent

Tools

Microsoft Office

Job description

PCI Pharma Services is seeking a QA professional to support GMP operations, audits, and documentation review. This role ensures a compliant cGMP environment and contributes to batch disposition documentation.

The ideal candidate has strong organizational and analytical skills, knowledge of cGMP and GMP documentation practices, and experience with investigations, CAPAs, and change controls.