Manufacturing QA Specialist

About the role

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.

Responsibilities

• Maintain compliance with site SOPs/cGMPs during production and warehouse operations.
• Support required QA inspections, including sample defect detection.
• Participate in internal audits, as requested.
• Provide primary daily support to the production and warehouse area, including tasks such as packaging line clearance verification, material segregation/containment, low product fill response, rework reconciliations/accountabilities, and documentation real-time review.
• Respond to exceptions within the operations/packaging areas, conducting initial exception impact assessments, product containment, bracketing, initial scope identification, and directing immediate actions before resuming processing.
• Assist personnel in generating operations/packaging area-related exceptions.
• Support minor exceptions and phase II manufacturing investigations.
• Attend daily operations staff communication meetings.
• Participate in Facilities meetings regarding operations Preventive Maintenance/Calibration/Work Order status and scheduling.
• Assist during area shutdown or maintenance projects as needed.
• Generate and verify punch lists, and conduct pre/post activity area inspections.
• Perform weekly walkthroughs of the operations/packaging area and communicate any observations to associated area management.
• Pass visual acuity exams for production and identify quality product purposes.
• Support batch release functions on an as needed basis.
• Participate in site and departmental initiatives.

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.
• Skilled competency with computers, MS Office software required.

Qualifications

• Familiarity with deviation management, root cause analysis, and execution of corrective and preventative actions (CAPA) required.
• 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.) preferred.

Skills

• Strong attention to detail.
• Excellent organizational and problem-solving skills.
• Ability to work independently and as part of a team.
• Proficiency with computer applications, particularly MS Office.

Benefits

At Guerbet, we offer a competitive salary, along with continued personal development opportunities. Join us to be part of a global leader in medical imaging, dedicated to improving the lives of patients worldwide.

Pay

Competitive salary based on qualifications and experience.

Schedule

Second shift schedule.