Pharmaceutical QA/QC Senior Specialist
The International Society for Pharmaceutical Engineering, Inc., Sanford, NC, United States
Job Description
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 Qualifications
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 cGMPLaboratory 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. Minimum Qualification
Valid drivers license and personal transportation Authorization to work in the United States indefinitely without restrictions or sponsorship. Additional Information
Positions are full-time, Monday - Friday 8am - 5 pm with overtime as needed. Candidates currently living within a commutable distance of Sanford, NC are encouraged to apply. What we offer
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 Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
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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 Qualifications
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 cGMPLaboratory 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. Minimum Qualification
Valid drivers license and personal transportation Authorization to work in the United States indefinitely without restrictions or sponsorship. Additional Information
Positions are full-time, Monday - Friday 8am - 5 pm with overtime as needed. Candidates currently living within a commutable distance of Sanford, NC are encouraged to apply. What we offer
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 Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
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