Manufacturing QA Specialist

Laboratoire Guerbet•Raleigh, IL

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

Monitors compliance to meet or exceed site SOPs/cGMPs during production and warehouse operations.
Supports required QA inspections, i.e. Sample defect detection.
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.