Quality Assurance Technical Associate
Qualified candidates must have:
- Quality Assurance experience in the pharmaceutical industry or laboratory environment PREFERRED
- Excellent cGMP knowledge
- Strong organizational skills
- Microsoft Word and Excel proficiency
- Technical writing skills (be able to provide sample on request)
- Ability to work independently and as part of the team
- Bachelor’s degree in a science discipline – strong science background, chemistry preferred.
Responsibilities may include:
- Analytical support/product development, formulation review, protocol approvals
- Familiarity with CMC sections of abbreviated new drug applications
- Document activation and distribution: SOPs, specifications, protocols, etc.
- Analytical review: Must be able to review, interpret, and approve analytical reports
- Stability data: Interpret results, trend analysis, and approval of stability data
- Issuance and control of preventative maintenance documentation
- Lab audits
- Batch record maintenance and issuance
- Final batch record review, release, and pedigree issuance
- Support in various specialized software systems, such as Calibration program, documentation software, temperature monitoring, etc.
- Incident and investigation writing
- Technical support as needed.
