Labcorp
BioPharmaceutical
GMPQualitySpecialist
“GMP Quality Specialist at Labcorp. Skills: GMP Quality Assurance, Validation, CAPA, Change Control. Participate in projects for validation and qualification. Review metrology methods and specifications”
What You'll Achieve.
Ensure facilities, utilities, equipment and computer systems are appropriately validated & qualified; Ensure accuracy / relevance and compliance with appropriate quality standards; Ensure compliance with applicable regulations; Improve efficiency / effectiveness of GMP operations
Industry & Context.
Problem Solving; Root Cause Investigations; Risk Assessments
What They're Looking For.
Must Have
Bachelor’s Degree, e. g. Biology, Chemistry, Pharmacy, or relevant Engineering discipline, 3 or more years of experience in GMP Quality Assurance role in an analytical testing or manufacturing environment, Experience with CAPA, change control, deviations, pharmaceutical QC testing methodologies and equipment validation procedures, Fluency in English and Dutch
Nice to Have
Higher level qualification and/or equipment management /regulatory qualifications, 2 or more years experience working in GMP compliant QC analytical laboratory environment, 3 or more years of experience in GMP Quality Assurance role, 2 or more years of experience in equipment validation and qualification, Understanding of applicable regulations and quality management systems / principles, tools, and standards, Detail oriented with knowledge of quality metrics and previous auditing experience preferred, Good interpersonal / organizational skills, e. g. communication, decision making, problem solving, data analysis, negotiating, influencing, Customer service oriented
What You'll Do.
Participate in projects for validation and qualification
Review metrology methods and specifications
Approve Quality Related Issue Resolutions
Facilitate root cause investigations
Review and approve pharmaceutical GMP studies
Monitor and report quality metrics
Participate in regulatory training development
Support the annual audit program
Support validation and verification activities
Contribute to continual improvement initiatives
Review and approve site-based controlled documents
Ensure RC&QA responsibilities are followed
How You'll Work.
Team & Collaboration
Work with product team; Support external vendor assessments; Provide back room assistance during inspections
Communication Scope
Communication; Decision Making; Problem Solving; Data Analysis; Negotiating; Influencing
Process & Methodology
Planning audits
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