QA Technical Associate

This role supports Quality Assurance activities across analytical, laboratory, and product development functions in a regulated pharmaceutical environment. The position ensures that documentation, data, and processes comply with cGMP and internal quality standards while supporting batch release, stability, and continuous improvement activities.

• Strong knowledge of cGMP and regulatory requirements.
• Strong organizational, documentation, and time‑management skills.
• Proficiency in Microsoft Word and Excel.
• Strong technical writing skills; ability to provide writing samples upon request.
• Ability to work independently and collaboratively in a cross‑functional team environment.

• Provide QA support for analytical testing, product development, and formulation activities, including protocol review and approval.
• Review and approve analytical reports; interpret data to ensure compliance with specifications and regulatory expectations.
• Support review of CMC sections of regulatory submissions such as abbreviated new drug applications (ANDAs).
• Manage document activation, control, and distribution for SOPs, specifications, protocols, and related controlled documents.
• Review, interpret, trend, and approve stability study data.
• Issue and maintain preventative maintenance and calibration documentation.
• Support laboratory audits and inspections, including preparation and follow‑up activities.
• Maintain, issue, and review batch records; perform final batch record review, release, and pedigree issuance.
• Support and maintain data within specialized quality and laboratory systems, including calibration systems, document management systems, and temperature monitoring systems.
• Author and support deviation, incident, and investigation documentation.
• Provide technical and quality support to laboratory, manufacturing, and product development teams as needed.

Not Applicable

Full-time

Quality Assurance

Staffing and Recruiting and Pharmaceutical Manufacturing

Medical insurance

Vision insurance

401(k)