QA Associate II — On-Floor GMP Compliance Lead

PCI Pharma Services; San Diego (CA); On-site; USD 33,000 - 37,000; Full time

Benefits offered by this job

Health insurance

Paid time off

401(k) plan

Flexible spending account

Job summary

PCI Pharma Services in San Diego, CA, is seeking a QA Associate II to ensure compliance with QA and regulatory requirements on the manufacturing floor. You will review records, approve batch data, and support on-floor data integrity during manufacturing operations.

Responsibilities include data entry for calibration, maintenance, and validation; supporting asset management and QARM; and training junior staff to uphold cGMP standards while maintaining a safe and compliant work environment.

Qualifications

• Bachelor's degree in Life Sciences or equivalent.
• 2–4 years of QA or related documentation experience.
• Knowledge of cGMP regulations and GxP practices.
• Ability to follow detailed directions in labs.

Responsibilities

• Review records and data for GMP operations.
• Approve internal production batch records for product disposition.
• Perform data entry for calibration, preventive maintenance and validation activities.
• Support the Red Tag and Asset Management Process and QARM responsibilities.
• Lead on-floor quality oversight during manufacturing operations.

Skills

QA documentation

cGMP regulations

Color vision

Detail orientation

Education

Bachelor's degree in Life Sciences

Tools

Documentation systems

Job description

PCI Pharma Services in San Diego, CA, is seeking a QA Associate II to ensure compliance with QA and regulatory requirements on the manufacturing floor. You will review records, approve batch data, and support on-floor data integrity during manufacturing operations.

Responsibilities include data entry for calibration, maintenance, and validation; supporting asset management and QARM; and training junior staff to uphold cGMP standards while maintaining a safe and compliant work environment.