Pharmaceutical QA/QC Senior Specialist

Eurofins PSS Insourcing Solutions; Sanford (NC); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Paid vacation and holidays

Job summary

A leading company in life sciences is seeking a Quality Assurance professional for their facility in Sanford, NC. The ideal candidate will possess a Bachelor's or Master's in a related field and substantial experience in a cGMP environment. Responsibilities include reviewing QA documentation and providing compliance approvals while collaborating with cross-functional teams. This full-time position offers competitive benefits and weekdays only schedule.

Qualifications

• 6-8 years of experience with a Bachelor's, or 4-6 years with a Master's.
• Experience in a cGMP microbiology lab is required.
• Strong understanding of data integrity and quality systems.

Responsibilities

• Review and approve QA documentation including validations and assessments.
• Provide QA approval for change controls and lab investigations.
• Collaborate to resolve technical quality issues.

Skills

Communication

Problem Solving

Education

Bachelor's or Master's Degree in Microbiology, Chemistry, or related field

Job 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, as well as in agroscience Contract Research Organisation services. It is a market leader in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences, and clinical studies support. It has an emerging global presence in Contract Development and Manufacturing Organisations and a rapidly developing presence in highly specialised molecular clinical diagnostic testing and in-vitro diagnostic products.

Over 30 years, Eurofins has grown from a single laboratory in Nantes, France, to 58,000 staff across a decentralized network of 900 laboratories in over 54 countries. The company offers a portfolio of over 200,000 analytical methods to evaluate safety, identity, composition, authenticity, origin, traceability, and purity of biological substances and products.

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

Job Description

This role is located in Sanford, NC.

Position Responsibilities:

• Review and approve QA documentation, including validation protocols, method transfers, and compendial assessments.
• Provide final QA approval for change controls, CAPAs, deviations, and lab investigations (OOS/OOT/OOE).
• Support electronic record reviews and compendial change documentation.
• Make real-time quality decisions in compliance with cGMP and regulatory standards.
• Collaborate cross-functionally to resolve technical and quality issues.
• Contribute to start-up activities and perform additional QA duties as needed.

Qualifications:

• Bachelor's or Master's Degree in Microbiology, Chemistry, Pharmaceuticals, or related field.
• Experience requirements vary: Bachelor's degree with 6-8 years, Master's degree with 4-6 years.
• Experience in a cGMP microbiology lab is required, with familiarity with USP, JP, and EMEA standards.
• Strong understanding of data integrity, root cause analysis, and quality systems.
• Prior QA experience supporting QC documentation investigations.
• Effective team player with strong communication and problem-solving skills.

Additional requirements include a valid driver’s license, personal transportation, and authorization to work indefinitely in the US.

Additional Information:

This is a full-time position, Monday-Friday, 8 am-5 pm. Candidates living near Sanford, NC are encouraged to apply. Benefits include medical, dental, vision, life and disability insurance, 401(k) with company match, paid vacation, and holidays.

Eurofins USA PSS Insourcing Solutions is an Equal Employment Opportunity employer, supporting disabled and veteran applicants.

Other Details:

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Production