Quality Assurance Specialist/Sr. Specialist, Biopharma Manufacturing

This is a stellar opportunity within an established global healthcare company focused on driving change to defeat diabetes and other serious chronic diseases. The ideal candidate would be responsible for reviewing manufacturing and support documentation and records to certify compliance. Your responsibilities will also include:

* Assisting with internal audit programs and serving as a Quality Assurance (QA) presence on the manufacturing floor.

* Participating in walk-through audits of manufacturing facilities.

* Reviewing and assessing deviations (including tracking, follow-up, and reporting/trending) and Corrective and Preventative Actions (CAPAs).

* Reviewing and approving validation documentation.

* Reviewing manufacturing and support records to ensure compliance with specifications and procedures.

* Working closely with Manufacturing and Quality Control to resolve issues resulting from record reviews, walk-through audits, and deviation issues.

* Assisting with performance and reporting of scheduled internal and vendor audits.

* Participating in Regulatory Inspections.

Desired Skills & Experience

* Bachelor’s Degree, or equivalent work experience, in Biology, Biotechnology, Molecular Biology, Microbiology, or related scientific discipline.

* 1+ years of QA related experience, preferably within a pharmaceutical or biotechnology company.

* Excellent troubleshooting skills and ability to exercise judgment within defined practices and policies to determine appropriate action.

* Ability to follow general instructions for routine work, and detailed instructions for new assignments. * Strong oral and written communication and negotiation skills.

* Strong organizational and planning skills.

* Ability to adjust quickly for changes in work priorities.