QA/QC Oversight Specialist — Pharma/Biotech

Eurofins PSS Insourcing Solutions; Sanford (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Eurofins USA PSS Insourcing Solutions is seeking a QA professional to oversee QC activities in a biotech/pharma environment. The role includes reviewing and approving method validation, equipment qualification, and related QA documentation to ensure compliance.

Strong GMP background is required, with experience in transfers, investigations, change controls, and analytical methods like HPLC and GC. Must have US work authorization and be ready for site-based work in Sanford, NC.

Qualifications

• BS or BA in a science or related field with a minimum of 4 years' experience in biotech/pharmaceutical settings.
• GMP experience is required.
• Direct experience with Method Transfer Validation, Investigations, Change Controls, and Equipment Qualification.
• Experience with HPLC, GC, and raw materials testing.
• Ability to drive process improvements.
• Pharmacopia experience preferred.
• US work authorization without restriction.

Responsibilities

• 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.

Skills

Quality Assurance

GMP Experience

Method Transfer Validation

Investigations

Change Controls

Equipment Qualification

HPLC

GC

Raw Materials Testing

Process Improvements

Education

BS/BA in life sciences or related field

Job description

Eurofins USA PSS Insourcing Solutions is seeking a QA professional to oversee QC activities in a biotech/pharma environment. The role includes reviewing and approving method validation, equipment qualification, and related QA documentation to ensure compliance.

Strong GMP background is required, with experience in transfers, investigations, change controls, and analytical methods like HPLC and GC. Must have US work authorization and be ready for site-based work in Sanford, NC.