Job Summary
The Quality Assurance (QA) Assistant supports the Quality Department in ensuring that Over-the-Counter (OTC) drug products and cosmetics are manufactured, tested, packaged, and released in compliance with FDA regulations (21 CFR Part 210/211 and applicable cosmetic GMP guidance such as 21 CFR Part 700 and ISO 22716), company Standard Operating Procedures (SOPs), and customer specifications. This role performs document review, batch record verification, inspection reports, and administrative quality tasks under the guidance of the Quality Manager.
This is an on-site position based in Whittier, CA and requires on-site presence five days a week. This is a full-time position with a Monday-Friday schedule, 8:00 AM to 4:30 PM.
Responsibilities
- Review batch records for accuracy and compliance with SOPs and cGMP prior to product release
- Inspect raw materials, in-process components, and finished goods
- Verify supplier documentation (e.g., certificates of analysis/compliance) against approved specifications
- Review labels and packaging artwork for alignment with approved specifications prior to release
- Maintain QA documentation, audit reports, and non-conformance/corrective action records
- Log and route customer complaints for investigation
- Use PPE per safety protocols during inspections
- Assist the Quality Manager with quality-related tasks as needed, including drafting and updating SOPs, supporting audits, coordinating documentation, and other QA initiatives
Qualifications
- B.S. in Chemistry, Biology, or related science (preferred); OR High school diploma or GED with 3+ years of QA/QC experience in OTC drug or cosmetic manufacturing
- Familiarity with cGMP, FDA OTC regulations, and/or cosmetic GMP (ISO 22716) preferred
- Proficient in Microsoft Office (Word, Excel, Outlook)
- Strong attention to detail and documentation accuracy
- Prior experience in pharmaceutical, OTC drug, or cosmetic manufacturing a plus
Physical Demands
- Ability to sit or stand for extended periods and use a computer for most of the workday
- Occasional lifting of up to 25lbs (e.g. sample containers, boxes of records)
- May require wearing PPE (safety goggles, gloves, hairnets, lab coats) when on production floor or in the laboratory
Pay: $20.00 - $24.00 per hour
Work Location: In person
