Position SummaryWoodstock Sterile Solutions is seeking an MQA Supervisor to lead day shift quality assurance operations and support the consistent manufacture of safe, compliant, high-quality sterile pharmaceutical products. This role provides day-to-day leadership for QA Specialists and QA Associates while partnering closely with Operations, Maintenance, MQA Management, customers, and regulatory agencies.
The MQA Supervisor coordinates quality activities across the manufacturing environment, including batch record review, document control, training, deviations, CAPA, quarantines, quality metrics, customer complaints, audits, and continuous improvement initiatives. This position will be scheduled for Monday through Friday, 6:00AM - 2:30PM.
Key Responsibilities- Lead shift QA operations, including scheduling and work assignments for QA Specialists and QA Associates.
- Provide leadership, direction, coordination, and review of QA team activities in support of manufacturing operations.
- Perform and oversee batch record review, document change control, training, deviation, CAPA, quarantine, and quality-metric activities.
- Investigate, analyze, troubleshoot, resolve, and document quality issues in collaboration with Operations, Maintenance, MQA Management, and customers.
- Initiate, review, and complete quality documentation, including batch records, SOPs, work instructions, quarantines, deviations, validation protocols, customer complaints, and training records.
- Communicate quality issues promptly to MQA and Operations Management and support timely, appropriate decisions related to product quality, compliance, and customer commitments.
- Support customer and regulatory audits and contribute to effective responses and follow-up actions.
- Maintain the effectiveness of quality-system components relevant to the position and drive improvements in quality systems, business systems, and processes.
- Identify, evaluate, and manage product-quality risk; communicate applicable risk policies and processes throughout the organization.
- Develop staff capability, teamwork, flexibility, and individual performance through coaching, training, and daily leadership.
- Perform other duties as assigned.
Required QualificationsEducation and Experience- Bachelor of Science degree preferred, or equivalent combination of education and relevant work experience.
- Four to six years of relevant experience in the pharmaceutical industry.
- Experience with cGMP and FDA regulations.
- Experience supporting regulatory audits preferred.
Knowledge and Skills- Demonstrated ability to lead personnel and coordinate work across multiple functions.
- Excellent verbal, written, interpersonal, and communication skills.
- Ability to manage multiple complex tasks and make timely, appropriate decisions involving product quality, compliance, and customer needs.
- Strong statistical/math, root-cause analysis, troubleshooting, and computer/software skills.
- Experience handling and responding to customer complaints and inquiries.
- Ability to read, understand, execute, and communicate written English SOPs.
- Ability to read, write, and speak clear English.
Physical and Work Environment- Frequent sitting, standing, walking, reading written documents, using a computer monitor, reaching, talking, writing, and listening.
- Occasional bending, grasping, carrying, stooping, kneeling, and crouching.
- Frequent lifting and/or moving up to 10 pounds, with occasional lifting and/or moving up to 30 pounds.
- Fast-paced, performance-driven, customer-focused, collaborative, and inclusive work environment.
