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Pharmaceutical Senior QA and QC Specialist

3 months ago

Sanford, United States Eurofins USA PSS Insourcing Solutions Full time
Job DescriptionJob DescriptionCompany Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

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

  • 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


Additional Information

  • Position is full-time, Monday-Friday, first shift 8AM-5PM. Candidates currently living in a commutable distance to Sanford, NC are encouraged to apply.

  • 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
  • #LI-EB1

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.