QA and QC Specialist

Eurofins USA PSS Insourcing Solutions; Sanford (NC); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Medical, dental, and vision coverage

Job summary

Eurofins USA PSS Insourcing Solutions is seeking a QA professional to oversee QC activities and ensure GMP standards. The role involves reviewing method validation, equipment qualification and change controls to support pharmaceutical manufacturing processes.

Candidates should have a BS/BA in a scientific field with at least 4 years in biotech/pharma settings, and be authorized to work in the United States. On-site in Sanford, NC, with full-time hours and comprehensive benefits.

Qualifications

• BS or BA degree in a scientific field, with a minimum of 4 years of experience in manufacturing, laboratory, quality, technical or engineering within biotech or pharma.
• GMP experience required.
• Direct experience with Method Transfer Validation, Investigation, Authoring Change Controls, Equipment Qualification.

Responsibilities

• Provide QA oversight of QC activities and ensure compliance with regulations.
• Review and approve QC method validation, equipment qualification, protocols, reports and procedures.
• Support evaluation and resolution of QC deviations and investigations, and contribute to process improvement initiatives.

Skills

QA oversight

QC method validation

Equipment qualification

Change controls

Deviations investigations

Process improvement

Biotech/pharma industry experience

Education

BS or BA degree in a scientific field

Tools

HPLC

GC

Raw materials testing

Job 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

• 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
• Supportthe evaluation and resolution of QC deviations and investigations, and contributeto 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-5pmwith overtime as needed. Candidates currently living within a commutable distance ofSanford, NCare 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.