Eurofins PSS Insourcing Solutions
Pharmaceutical QA Senior Specialist - Group Leader
Eurofins PSS Insourcing Solutions, Sanford, North Carolina, United States, 27330
Pharmaceutical QA Senior Specialist - Group Leader
Eurofins Scientific is an international life sciences company, providing a range of analytical testing services to clients across multiple industries. Our mission is to make life and the environment safer, healthier, and more sustainable. We work with major companies worldwide to ensure product safety, authenticity, and accurate labelling. Our network of over 900 laboratories in more than 54 countries employs 58,000 staff and offers over 200,000 analytical methods to evaluate biological substances and products. Job Description
This position oversees Quality Assurance for Quality Control (QC). Responsibilities include reviewing and approving validation/qualification documents, QC protocols, reports, process control documents, procedures, and investigations related to QC. The role supports process improvements and is based in Sanford, NC. Position Responsibilities Perform QA technical reviews for validation documents, transfer protocols, and related areas. Approve change controls, effectiveness checks, CAPAs, and assessments. Review and approve deviation reports, investigations, lab events, electronic records, and related documentation. Make real-time quality decisions in accordance with regulations and procedures. Collaborate with internal teams to resolve technical issues. Support activities for start-up operations and other duties as assigned.
Qualifications Bachelor's or Master's Degree in Microbiology, Chemistry, Pharmaceuticals, or related field. Experience: 6-8 years for Bachelor's degree holders; 4-6 years for Master's degree holders. Relevant experience in biotech or pharmaceutical manufacturing, laboratory, quality, or engineering roles. Experience in a cGMP QC laboratory environment. Knowledge of pharmacopeia standards (USP, JP, EMEA), data integrity, deviations, change controls, and CAPA processes. Ability to work collaboratively and make informed quality decisions. Valid drivers license and personal transportation.
Additional Information
Full-time, Monday-Friday, first shift (8AM-5PM). Candidates in or near Sanford, NC are encouraged to apply. Benefits include medical, dental, vision, life and disability insurance, 401(k) with match, paid vacation and holidays. Eurofins is an Equal Opportunity Employer, supporting diversity and inclusion.
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Eurofins Scientific is an international life sciences company, providing a range of analytical testing services to clients across multiple industries. Our mission is to make life and the environment safer, healthier, and more sustainable. We work with major companies worldwide to ensure product safety, authenticity, and accurate labelling. Our network of over 900 laboratories in more than 54 countries employs 58,000 staff and offers over 200,000 analytical methods to evaluate biological substances and products. Job Description
This position oversees Quality Assurance for Quality Control (QC). Responsibilities include reviewing and approving validation/qualification documents, QC protocols, reports, process control documents, procedures, and investigations related to QC. The role supports process improvements and is based in Sanford, NC. Position Responsibilities Perform QA technical reviews for validation documents, transfer protocols, and related areas. Approve change controls, effectiveness checks, CAPAs, and assessments. Review and approve deviation reports, investigations, lab events, electronic records, and related documentation. Make real-time quality decisions in accordance with regulations and procedures. Collaborate with internal teams to resolve technical issues. Support activities for start-up operations and other duties as assigned.
Qualifications Bachelor's or Master's Degree in Microbiology, Chemistry, Pharmaceuticals, or related field. Experience: 6-8 years for Bachelor's degree holders; 4-6 years for Master's degree holders. Relevant experience in biotech or pharmaceutical manufacturing, laboratory, quality, or engineering roles. Experience in a cGMP QC laboratory environment. Knowledge of pharmacopeia standards (USP, JP, EMEA), data integrity, deviations, change controls, and CAPA processes. Ability to work collaboratively and make informed quality decisions. Valid drivers license and personal transportation.
Additional Information
Full-time, Monday-Friday, first shift (8AM-5PM). Candidates in or near Sanford, NC are encouraged to apply. Benefits include medical, dental, vision, life and disability insurance, 401(k) with match, paid vacation and holidays. Eurofins is an Equal Opportunity Employer, supporting diversity and inclusion.
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