Pharmaceutical QA/QC Senior Specialist at Eurofins

Sanford, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

10 Jun, 26

Salary

0.0

Posted On

12 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance Oversight, Quality Control Activities, Method Validations, Equipment Qualifications, Protocols, Reports, Procedures, Deviations, Process Improvements, Change Controls, CAPAs, Compendial Assessments, Investigations, Data Integrity, Root Cause Analysis, cGMP Laboratory Environment

Industry

Medical and Diagnostic Laboratories

Description

Company 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 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 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. 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. Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Responsibilities

This role involves providing Quality Assurance oversight for Quality Control activities, including the review and approval of various documents such as method validations, equipment qualifications, protocols, reports, procedures, and deviations. The specialist will also support the implementation of process improvements and make real-time quality decisions per regulations.