Quality Assurance Engineer III
Description of Duties:
- Author or Review validation protocols and reports
- Perform statistical analysis/hypotheses testing
- Support CAPA, Deviation, Change Control, and Complaints
- Reviews executed manufacturing batch records for completeness, compliance, and accuracy to support product lot disposition
- Assists in administrating the document control system. Duties include but are not limited to supporting document change control activities, document generation, tracking and distribution for review, approval and filing.
- Reviews QC data generated from manufactured product, raw materials and intermediates
- Write/revise/review SOPs for compliance to internal procedures and FDA regulations
- Independently interacts with other groups to proactively address compliance concerns and resolve problems
- Perform Software validations
- May participate on cross-functional compliance improvement projects
- Lead internal and external audits
- BS in Engineering, Chemistry, Biology or other relevant discipline.
- 4+ years QA or equivalent experience.
- Prior hands-on experience establishing and/or maintaining electronic compliance systems is required.
- Strong understanding of cGMP’s and QSR’s
- Understanding of scientific/technical concepts.
- Good analytical skills.
- Clear, concise writing skills and good verbal presentation skills.
- Excellent organizational skills and attention to detail.
- Ability to interact constructively and efficiently with co-workers
- Works on moderately complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
- Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- Demonstrates strong understanding of procedures and methods for review function.
- Works under only general direction. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives.
- ASQ CQE preferred