QA and QC Specialist

Eurofins PSS Insourcing Solutions; Sanford (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Eurofins USA PSS Insourcing Solutions is seeking a QA professional to oversee QC activities in a biotech/pharma environment. The role includes reviewing and approving method validation, equipment qualification, and related QA documentation to ensure compliance.

Strong GMP background is required, with experience in transfers, investigations, change controls, and analytical methods like HPLC and GC. Must have US work authorization and be ready for site-based work in Sanford, NC.

Qualifications

• BS or BA in a science or related field with a minimum of 4 years' experience in biotech/pharmaceutical settings.
• GMP experience is required.
• Direct experience with Method Transfer Validation, Investigations, Change Controls, and Equipment Qualification.
• Experience with HPLC, GC, and raw materials testing.
• Ability to drive process improvements.
• Pharmacopia experience preferred.
• US work authorization without restriction.

Responsibilities

• Responsible for providing Quality Assurance (QA) oversight of Quality Control (QC) activities.
• QA review and approval of QC method validation, equipment qualification, protocols, reports, process control documents, and both new and existing procedures.
• Support the evaluation and resolution of QC deviations and investigations, and contribute to the implementation of process improvement initiatives.

Skills

Quality Assurance

GMP Experience

Method Transfer Validation

Investigations

Change Controls

Equipment Qualification

HPLC

GC

Raw Materials Testing

Process Improvements

Education

BS/BA in life sciences 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 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.

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

• Responsible for providing Quality Assurance (QA) oversight of Quality Control (QC) activities
• QA review and approval of QC method validation, equipment qualification, protocols, reports, process control documents, and both new and existing procedures
• Support the evaluation and resolution of QC deviations and investigations, and contribute to the implementation of process improvement initiatives

The site is not accesible by public transportation routes.

Qualifications

• BS or BA degree Scientist or related field with a minimum of 4 years of experience in manufacturing, laboratory, quality, technical or engineering experience within biotech or the pharmaceutical industry
• GMP Experience required
• Direct experience needed with: Method Transfer Validation, Investigation, Authoring Change Controls, Equipment Qualification
• Experience with testing and execution of assays such as HPLC, GC, raw materials testing
• Ability to understand and drive process improvements
• Pharmacopia experience preferred
• Authorization to work in the United States indefinitely without restriction

Additional Information

Position is full-time, Monday-Friday 8am-5pm with overtime as needed. Candidates currently living within a commutable distance of Sanford, NC are encouraged to apply. This site is not accessible by public transportation options; daily, reliable transportation is needed to and from the site.

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

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