Manufacturing QA Specialist - 2nd shift

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

Manufacturing Quality Assurance Specialist

The Manufacturing Quality Assurance Specialist will operate in full compliance with applicable hygiene, safety, quality and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for. The Manufacturing Quality Assurance Specialist provides on‑floor quality oversight across cGMP manufacturing operations, including formulation, filling, sterilization, packaging, and warehouse activities. The role ensures compliance with site SOPs and regulatory requirements through real time monitoring, review of critical process documentation, and verification of product and process controls. The position also supports sample inspections, responds to atypical quality events and nonconformance, facilitates containment and issue escalation, and partners with operations to ensure timely sampling, effective defect management, and continuous adherence to quality standards. This is a 2nd shift role.

Responsibilities

• Monitors compliance to meet or exceed site SOPs/cGMPs during production and warehouse operations.
• Ability to participate in internal audits, as requested.
• Provides primary daily support to the production and warehouse area, up to and including tasks such as packaging line clearance verification, material segregation/containment, low product fill response, rework reconciliations/accountabilities, and documentation real time review.
• Primary QA event response personnel that will respond to exceptions within the operations/packaging areas, having functions of initial exception impact assessment, product containment, bracketing, initial scope identification, and direction of immediate actions to take prior to resuming processing.
• Assists personnel in the generation of operations/packaging area related exceptions.
• Supports minor exceptions and phase II manufacturing investigations.
• Attends daily operations staff communication meetings.
• Team member of Facilities meetings regarding operations Preventive Maintenance/Calibration/Work Order status and scheduling.
• Team members during area shutdown or maintenance projects as needed.
• Assisting in punch list generation & verification, as well as area inspections pre/post activity.
• Perform weekly walkthroughs of the operations/packaging area and communicate any observations to associated area management.
• Ability to pass visual acuity exam for production and identification of quality product purposes.
• Ability to support the batch release functions on an as needed basis.
• Supports site and departmental initiatives.

Qualifications

Required Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline (e.g., Biology, Chemistry, Microbiology, Pharmaceutical Sciences) required.
• 3-6 years of experience in pharmaceutical manufacturing, quality assurance, or aseptic operations required.
• Hands‑on experience providing QA oversight on the manufacturing floor, including formulation, filling, sterilization, packaging, or warehouse GMP operations required.
• Prior experience performing or verifying line clearances, room clearances, and/or batch record review required.
• Familiarity with deviation management, root cause analysis, and execution of corrective and preventative actions (CAPA) required.
• Skilled competency with computers, MS Office software required.

Preferred Qualifications

• Experience observing and evaluating aseptic behaviors, gowning qualification, environmental controls, and contamination control practices preferred.
• Experience working with ISO, FDA, or EU Annex‑1 regulated environments preferred.
• Experience with pharmaceutical CAPA systems (e.g., Trackwise, Metric Stream, etc.)

Benefits

Much more than a competitive salary.

We offer continued personal development. When you join Guerbet, you:

• Are choosing a global leader with recognized expertise in diagnostic and interventional imaging.
• Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world.
• Are joining a company where we value diversity of talents coming from various horizon.

EEO Statement

Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to [e-mail] or you can also call this number+19843443717