2nd Shift: On-Floor Manufacturing QA Specialist

Guerbet; Raleigh (NC); On-site; USD 75,000 - 110,000; Full time

Job summary

Guerbet is seeking a Manufacturing Quality Assurance Specialist to oversee cGMP manufacturing activities, including formulation, filling, sterilization, packaging, and warehouse operations. The role ensures compliance with site SOPs and regulatory requirements through real-time monitoring and document review.

The candidate will support batch release, deviations, CAPA, and defect management while collaborating with operations to ensure quality is maintained across production and packaging areas.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related technical discipline.
• 3-6 years of experience in pharmaceutical manufacturing, quality assurance, or aseptic operations.
• Hands-on QA oversight on the manufacturing floor (formulation, filling, sterilization, packaging, or warehouse GMP).
• Experience performing or verifying line/room clearances and batch record review.
• Familiarity with deviation management and CAPA execution.
• Proficient with MS Office.

Responsibilities

• Monitor compliance to site SOPs/cGMPs during production and warehouse operations.
• Participate in internal audits as requested.
• Provide primary daily support to production and warehouse areas, including packaging line clearance verification and material segregation.
• Act as QA events lead for exception assessment, containment, and immediate actions to resume processing.
• Assist in generation of area-related exceptions and support CAPA investigations.

Skills

QA oversight

GMP operations

CAPA familiarity

MS Office

Education

Bachelor’s degree in Life Sciences or related field

Tools

Trackwise / Metric Stream CAPA systems

Job description

Guerbet is seeking a Manufacturing Quality Assurance Specialist to oversee cGMP manufacturing activities, including formulation, filling, sterilization, packaging, and warehouse operations. The role ensures compliance with site SOPs and regulatory requirements through real-time monitoring and document review.

The candidate will support batch release, deviations, CAPA, and defect management while collaborating with operations to ensure quality is maintained across production and packaging areas.