Role OverviewThe Quality Assurance Technical Operations Specialist proactively enhances and improves the site's quality oversight, regulatory compliance, internal procedures, and quality standards in support of Active Pharmaceutical Ingredient (API) manufacturing processes.
What You Will Do
Evaluate global harmonization and local requirements to identify areas of improvement and increased efficiency, translate the evaluation into a highly collaborative revision or authoring of standard operating procedures and work instructions.
Why It Might Be a Fit
A strong applied knowledge of cGMP investigations, including deviations, out-of-specification, and environmental excursions, as well as experience with conflict resolution and teamwork to drive positive change within the organization.
Requirements
- Bachelor's Degree in Biological Sciences, Chemistry, or Engineering
- At least 8 years in a cGMP environment
- At least 5 years working in Quality Assurance
- At least 5 years in the Pharmaceutical, Biopharmaceutical, or Medical Device industries
Benefits
- Competitive pay
- Annual performance bonus
- Generous benefit package with comprehensive Medical/Dental/Vision coverage
- 401(k) plan with employer contribution
- Paid vacation, personal and sick days
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