QA Associate II - GMP Compliance & On-Floor Oversight

PCI TRGR Penn Pharmaceutical Services Ltd; San Diego (CA); On-site; USD 33,000 - 37,000; Full time

Job summary

PCI Pharma Services is seeking a QA Associate II to perform routine and semi-routine QA activities, ensuring compliance with cGMP and regulatory requirements during manufacturing operations. The role leads projects, trains junior staff, reviews documents for accuracy, and supports calibration, maintenance, and validation activities; expects on-floor quality oversight.

Candidates should have a life sciences degree and 2-4 years of QA experience; knowledge of cGMP and good documentation practices

Qualifications

• Bachelor’s degree strongly preferred in a Life Sciences discipline or equivalent.
• 2–4 years of experience in documentation, QA, or equivalent.
• Knowledge of cGMP regulations and good documentation practices preferred.
• Ability to distinguish colors and follow detailed directions in a laboratory environment.

Responsibilities

• Reviews records and data for GMP operations (logbooks, cleaning logs, sterilization records, stability reports, buffer batch records).
• Assists review/approval of production batch records and data for product disposition.
• Performs data entry for calibration, preventive maintenance and validation activities.
• Supports asset management and QARM responsibilities.
• Provides on-floor quality oversight during manufacturing and packaging activities.

Skills

QA documentation

Regulatory compliance

cGMP knowledge

Attention to detail

Education

Bachelor’s degree in Life Sciences

Job description

PCI Pharma Services is seeking a QA Associate II to perform routine and semi-routine QA activities, ensuring compliance with cGMP and regulatory requirements during manufacturing operations. The role leads projects, trains junior staff, reviews documents for accuracy, and supports calibration, maintenance, and validation activities; expects on-floor quality oversight.

Candidates should have a life sciences degree and 2-4 years of QA experience; knowledge of cGMP and good documentation practices