Quality Assurance Specialist (GMP) — Biotech

Prolacta; Duarte (CA); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Healthcare coverage

401(k) match

PTO 4 weeks

Job summary

Prolacta Bioscience in Duarte, CA is seeking a Quality Associate to support cGMP operations and QA activities. You will participate in audits, review batch records, and assist with investigations while ensuring robust quality systems across production lines.

The role requires a degree in biology or related sciences and 2–5 years of regulated manufacturing experience, with strong written and interpersonal skills and flexibility to accommodate production needs.

Qualifications

• B.A./B.S. Degree in Biology, Biochemistry, Chemistry, or other related sciences.
• 2-5 years of experience in a regulated manufacturing environment.
• Knowledgeable with FDA regulations and cGMP. Knowledge of FDA 21 CFR 106, 107, 11 and 117 is highly desired.
• Strong written communication skills. Must be able to clearly document observation deviations.
• Excellent interpersonal skills to maintain partnerships between Quality and all departments to ensure the lines of communication are professional and congenial.
• Must effectively communicate with all levels of personnel.
• Must be flexible with hours to accommodate production/business needs.
• Ability to work in a cold environment for a limited period of time.

Responsibilities

• Understand quality procedures, safety procedures and cGxP procedures and systems.
• Lead or participate in risk assessments.
• Review in-process batch records/manufacturing run sheets and COAs to support product release.
• Perform/assist with internal/external GMP audits.
• Prepare Quality Metrics report for Monthly/Quarterly meetings and gather weekly metrics data.
• Lead manufacturing teams in the investigation and prevention of non-conformance issues.

Skills

Quality assurance

cGMP knowledge

FDA regulations

Written communication

Cross-functional collaboration

Education

B.A./B.S. in Science

Job description

Prolacta Bioscience in Duarte, CA is seeking a Quality Associate to support cGMP operations and QA activities. You will participate in audits, review batch records, and assist with investigations while ensuring robust quality systems across production lines.

The role requires a degree in biology or related sciences and 2–5 years of regulated manufacturing experience, with strong written and interpersonal skills and flexibility to accommodate production needs.