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Thermo Fisher Scientific · 5 days ago

Manager, Quality Control

High Point, NC

Full-time

Onsite

Mid, Senior Level, Lead/Staff

8+ years exp

Thermo Fisher Scientific is a company dedicated to making the world healthier, cleaner, and safer. The Manager of Quality Control will ensure that the QC laboratory is equipped for timely testing, provide mentorship to staff, and uphold safety regulations while representing Quality Control during audits.

BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine

No H1B

Security Clearance Required

Responsibilities

Ensures that the QC laboratory is well-equipped with the necessary personnel to conduct timely testing of non-commercial and pre-commercial samples, encompassing both process and cleaning validations

Provide mentorship and technical support to staff in troubleshooting instrumentation, root cause analysis, and implementing Corrective/Preventative Actions (CAPAs)

Collaborate with internal and external customers to support site and company initiatives

Uphold and implement safety regulations and company policies

Conduct regular 1-on-1 mentoring sessions and annual performance evaluations for team members

Represent Quality Control during audits and regulatory inspections

Qualification

Laboratory experienceCGMP knowledgeSupervisory experienceEmpower softwareChromeleon softwareMS WordMS ExcelRoot cause analysisCorrective/Preventative Actions

Required

BS degree with 8 years of laboratory experience preferably within a cGMP, pharmaceutical laboratory environment, including 2-3 years of supervisory experience

Meet applicable DEA security clearance requirements

Skilled in the interpretation of guidelines and employing rational or scientific reasoning

Proficiency in operating basic and complex laboratory equipment and software such as Empower, Chromeleon, MS Word, and Excel