Pharmaceutical QA/QC Senior Specialist
About The Position
This role will provide Quality Assurance oversight for Quality Control activities, including review and approval of method validations, equipment qualifications, protocols, reports, procedures, and deviations. The role supports implementation of process improvements. This is on-site in Sanford, NC Conduct QA reviews and approvals for validation documents, method transfer protocols, change controls, CAPAs, compendial assessments, and related records Review deviations, investigations (OOS/OOT/OOE), and other Quality Events/Lab Events, Electronic build of Master Batch or any electronic record when needed, and all associated to compendial changes Make real-time quality decisions per regulations, collaborate cross-functionally to resolve technical issues, and support start-up activities as assigned
Requirements
- Bachelor's or Master's Degree in relatable field (Microbiology, Chemistry, Pharmaceuticals, etc.)
- Bachelor's degree and 6-8 years of experience
- Master's degree and 4-6 years of experience
- Relevant experience includes: Manufacturing, laboratory, quality, technical or engineering experience within biotech of the pharmaceutical industry
- Experience in a Quality Control Laboratory and cGMP Laboratory environment.
- Familiarization with Pharmacopeia requirements. (e.g., USP, JP, EMEA amongst others.
- Familiarization with the Data Integrity requirements.
- Deviations, Change Controls, Stability Protocols, and all the implementation activities. Support in CAPA closures, Effectiveness checks, and experience in Root Cause Analysis tools.
- Experience in a quality assurance role, preferably in Quality Assurance for a Quality Control role in the document such as: (e.g., OOS (Out of Specification), OOE (Out of Expectation), OOT (Out of Trend) investigation, specification, method transfer protocol, stability protocol, and others).
- Proven ability to work in a team environment through conflict resolution and negotiation.
- Valid drivers license and personal transportation
- Authorization to work in the United States indefinitely without restrictions or sponsorship.
Responsibilities
- Conduct QA reviews and approvals for validation documents, method transfer protocols, change controls, CAPAs, compendial assessments, and related records
- Review deviations, investigations (OOS/OOT/OOE), and other Quality Events/Lab Events, Electronic build of Master Batch or any electronic record when needed, and all associated to compendial changes
- Make real-time quality decisions per regulations, collaborate cross-functionally to resolve technical issues, and support start-up activities as assigned
Benefits
- Excellent full time benefits including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
- Yearly goal-based bonus & eligibility for merit-based increases
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Professional, Scientific, and Technical Services
Number of Employees
5,001-10,000 employees
