QA Specialist
3 weeks ago
Job Description
POSITION SUMMARY:
This position provides Quality Assurance oversight for Quality Control (QC). Provide QA (Quality Assurance) review and approval of Quality method validation/ QC equipment qualification, QC protocol, reports, QC process control document, new and existing procedures, and Quality Control deviation/investigations. Supports process improvements implementation.
POSITION RESPONSIBILITIES:
Perform QA technical review for assigned areas such as Validation documents, Method transfer Protocol amongst others. Provide final QA approval on simple change control, effectiveness check, CAPA implementations, compendial assessments, and other documents associated with the business unit. May also review and approve documents such as Deviation, complaints investigations, Laboratory 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. Capable to Make quality decisions in real time according to regulations and procedures. Ability to work collaboratively with internal partners to resolve technical issues. Willing to perform other duties as assigned and take ownership to support the implementation of activities needed for the start-up.
Qualifications
BASIC MINIMUM QUALIFICATIONS:
Bachelor's Degree in relatable field (Microbiology, Chemistry, Pharmaceuticals, etc.) Ability to be problem-solving and analytical skills. Familiarized with Pharmacopeia and Regulatory Requirements. Attention to detail and the ability to work independently. Experience in Quality Control Laboratory cGMP’s Laboratory environment. Proven ability to work in a team environment through conflict resolution and negotiation. Provides excellent communication, writing, and analytical skills.PREFERRED QUALIFICATIONS:
2 – 5 years of manufacturing, laboratory, quality, technical or engineering experience within biotech of the pharmaceutical industry with a BS/BA Degree in Science / related / Field. Familiarized and experienced in Pharmacopeia requirements. (e.g., USP, JP, EMEA amongst others) Familiarization with the Data Integrity requirements. 2 - 5 years of experience such as deviations, Change Controls, Stability Protocols, and all the implementation activities. Support in CAPA closures, Effectiveness checks, and experience in Root Cause Analysis tools. At least 2 - 5 yrs. of 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).
Additional Information
Position is Full Time, Monday-Friday, 8:00am-5:00pm . Candidates currently living within a commutable distance of Sanford , NC are encouraged to apply. Excellent full-time benefits including comprehensive medical coverage, dental, and vision options.
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 Eligibility for potential yearly Bonus & Merit-Based Pay IncreasesEurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
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