Manufacturing Quality Assurance Supervisor (overnights)
This role supports the business by performing all quality related activities, as well as leading staff required to perform the activities. Key activities include lead QA staff, collect/analyze/report quality metrics, facilitate quarantines & Deviations in collaboration with Operations and Maintenance, resolve Quality issues, complete documentation, interact with customers and regulatory agencies including audits, support CAPA, and customer complaints.
Specific Duties, Activities, and Responsibilities
- Lead shift QA operations, including scheduling of QA Specialists and QA Associates, batch record review, document change control, training, Deviations, CAPA, and quality metrics.
- Provide leadership, schedule, coordinate, direct, and review the activities and work assignments for QA Specialists and QA Associates in support of operations
- Investigate, analyze and report key quality metrics, troubleshoot, resolve and document as required all quality issues that arise. Work collaboratively with Operations, Maintenance, MQA Management and the customer to assure compliance and on-time delivery.
- Initiate, review, and complete documentation. Documentation includes Batch Records, SOPs, Work Instructions, Quarantines, Deviations, Validation Protocols, Customer Complaints, and Training Records.
- Communicate Quality issues on a timely basis to MQA and Operations Management
- Drive improvements in quality systems, business systems, and processes.
- Develop staff to increase teamwork, individual capability and organizational flexibility.
- Provide support for customer and regulatory audits
- Maintain effectiveness of the Quality System components relevant to this position.
- Other duties as assigned
Education or Equivalent
- Bachelor Science Degree or equivalent work experience; BS in science preferred
- 4-6 years of relevant work experience in the pharmaceutical industry
- Knowledge and experience in cGMP/FDA regulations. Experience in regulatory audits desired
- Excellent verbal, written and interpersonal communication skills
- Demonstrated ability to lead personnel
- Demonstrated ability to handle multiple complex tasks and make timely/appropriate decisions with respect to product quality, compliance, and the customer
- Strong math (statistical), root cause analysis, troubleshooting, and computer/software skills
- Demonstrated experience n handling and responding to customer complaints and inquiries.
- Ability to read, comprehend, execute and communicate English written SOP’s.
- Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening
- Occasional bending, grasping, carrying, stooping, kneeling, crouching
- Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 30 pounds
- Performance driven
- Customer focused
- Collaborative and inclusive