Supervisor, Quality Assurance

 

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This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

 

Your Role:

The Supervisor, Quality Assurance position is responsible for leading the Quality Assurance Issuance and Product Release team within a complex parenteral manufacturing facility and providing functional leadership of Batch Record Review and Product Release, Batch Record Issuance, and related investigations/CAPAs. The individual champions continuous improvement activities with quantitative results that consistently deliver low cost, defect free products on-time. The position is a working supervisory position that supports production and related activities to product release. The position collaborates with other QA personnel, Quality Control, Operations, Clients and Suppliers to establish and maintain requirements for product release. Responsible for ensuring that all product manufactured and/or supported meet established specifications and regulatory requirements.

 

Responsibilities include:

• Oversee/perform activities for QA product release and issuance of GMP documentation
• Provide direct QA oversight over product release and issuance teams
• Ensure all duties are performed in accordance with cGMP
• Oversight of the issuance and release of GMP documentation for execution by Manufacturing personnel and other functional departments
• Ensure batch records are reviewed by Quality in a timely fashion, with established targets and visibility to stakeholders
• Supervise and perform the activities of the department including customarily and regularly directing, advising, and managing direct subordinates, as well as providing performance feedback
• Assess departmental productivity and efficiency in order to provide on time delivery of services by the department
• Participate in the appropriate selection and usage of resources (materials, systems and/or equipment) required for the effective operation of the department
• Provide for team member safety by promoting safe work practices, monitoring compliance with EHS policies, and minimizing physical hazards to promote an overall safe work environment
• Monitor Quality Assurance programs to ensure process controls are met, documents activities, and brings about corrective action as needed
• Assist in audits, documents audit results, and provides input and recommendations for necessary corrective action as needed
• Ensure adherence to the manufacturing schedule through effective planning and on-time issuance of GMP documentation
• Schedule and track conformance to batch release schedules, establish milestones and escalation processes
• Manage and/or support process-related investigations
• Train and qualify individuals on department activities
• Participate in the oversight and governance of the overall site quality systems, partner with quality colleagues to ensure communications between operations quality and product support quality personnel are effective
• Perform special projects and other duties as assigned
• Carry out all supervisory responsibilities in accordance with the organization’s policies and applicable laws

Who You Are:

Minimum Qualifications:

• Bachelor’s Degree in any discipline
• 3+ years quality assurance experience
• 1+ years supervisory experience

Preferred Qualifications:

• Bachelor's Degree in a Scientific discipline (Biology, Chemistry, Microbiology, etc.)
• Ability to operatie with a high level of autonomy
• Ability to work collaboratively with others
• Essential knowledge of cGMPs
• Experience with continuous improvement efforts
• Experience in client interactions
• Strong oral and written communication skills
• Strong ability to train/qualify others in activities related to pharmaceutical manufacturing quality

 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access