QA and QC Specialist

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

Benefits offered by this job

Medical coverage

Dental & vision

401(k) with match

Paid vacation and holidays

Life and disability insurance

Job summary

Eurofins PSS Insourcing Solutions is seeking a Quality Assurance professional to provide QA oversight of QC activities within a biotech/pharmaceutical manufacturing environment. The role includes QA review and approval of QC method validation, equipment qualification, protocols, reports, and process control documents.

Ideal candidate will have 4+ years in manufacturing, laboratory, quality, or engineering within biotech/pharma, GMP experience, and hands-on experience with method validation,

Qualifications

• BS or BA in science or related field, with minimum 4 years of experience in biotech/pharmaceutical manufacturing, lab, quality, or engineering.

Responsibilities

• QA oversight of QC activities and assurance of quality systems.
• QA review/approval of QC method validation, equipment qualification, protocols, reports and related documents.
• Support evaluation and resolution of QC deviations/investigations and drive process improvements.

Education

BS or BA in science or related field

Tools

Method Transfer Validation

Investigation

Change Controls

Equipment Qualification

HPLC

GC

Raw materials testing

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.

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 accessible 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. 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.