Senior GxP QA Specialist & Lead Auditor

Precision Medicine Group, LLC.

Winston-Salem (NC)

Hybride

USD 92 000 - 137 000

Plein temps

14 jours+

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Avantages offerts par ce poste

Discretionary bonus
Health insurance
Retirement savings
Life insurance
Disability benefits
Parental leave
Paid time off

Résumé du poste

Precision Medicine Group in Winston-Salem, NC is seeking a Quality Assurance Specialist III to provide on-site, advanced QA support within a regulated GxP laboratory and kitting production environment.

You will manage document control, lead internal and supplier audits, review CAPAs, and ensure release of materials and products, while mentoring junior staff and collaborating across departments to maintain compliance and quality systems.

Qualifications

  • Bachelor’s Degree or equivalent combination of education and experience in a life sciences-regulated environment.
  • 4 years of related experience in a life science, regulated environment.
  • Experience working in a Quality Department with internal audits, document review, batch release, and inspections.

Responsabilités

  • Maintain established GxP quality systems and document quality events.
  • Lead internal and supplier audits; act as lead auditor.
  • Manage the document and record control system.
  • Provide guidance to junior QA specialists and train staff.
  • Support calibration programs and equipment maintenance.

Connaissances

Quality assurance
GxP
Audit

Formation

Bachelor’s Degree or equivalent

Outils

Microsoft Office

Description du poste

Precision Medicine Group in Winston-Salem, NC is seeking a Quality Assurance Specialist III to provide on-site, advanced QA support within a regulated GxP laboratory and kitting production environment.

You will manage document control, lead internal and supplier audits, review CAPAs, and ensure release of materials and products, while mentoring junior staff and collaborating across departments to maintain compliance and quality systems.

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