Little Rock, Arkansas
Quality Assurance Manager - Supplier Quality Job Opening in Little Rock, Arkansas - Under the direction of the Director of Quality, the Quality Assurance Manager leads a cross-functional Quality Assurance team. The QA team supports Compounding Pharmacy Operations and is responsible for, but not limited to, on the floor auditing, batch record review, AQL inspections, Supplier Quality Assurance, Deviation and CAPA management. This key individual provides the Quality Management oversight when Compounding, Inspection, Packaging and Warehousing are in operation. Typically, the qualified person has experience managing a team of Quality Assurance personnel with a strong knowledge of cGMP.
Key Responsibilities:
Drives delivery of day-to-day Quality Assurance activities, ensuring adherence to plan and schedule.
Provides advice and knowledge in regard to interpreting Good Manufacturing Practice guidelines and regulations.
Primary contact for communication of supplier quality issues with all suppliers.
Reviews and approves raw material and finished product specifications.
Proactively looks for opportunities to identify change, increase efficiency, influence decisions and deliver results while ensuring compliance.
Provides oversight and works directly in the incoming Quality Assurance program to assure that all specifications are developed and adhered to.
Manages the review of batch records and associated documentation for release of finished product(s). Ensures that all necessary documentation for release of product is completed, all deviations are resolved, and all specifications have been met prior to release of any product.
Monitors on the floor inspection of product and provides timely input to ensure proper completion.
Responsible for site internal audit program.
Schedules employees in regards to workload and backlog to ensure efficiency.
Mentors direct reports as needed.
Serves as facility expert in assessing the impact of excursions and deviations throughout the manufacturing process.
Drives to root cause during process investigations.
Demonstrates skill in maintaining internal customer relationships.
Effectively leads and trains employees.
Maintains strong communication network with peers.
Additional responsibilities as assigned
Qualifications
Knowledge: Familiarity with regulatory requirements for a 503B Compounding Outsourcing Facility, or applicable experience in sterile pharmaceutical, medical device, or biotech manufacturing and a thorough knowledge and understanding of cGMP.
Skills: Leadership, critical thinking, decision-making, effective communication, .
Minimum Education: 4 year degree in life sciences, engineering, or related discipline.
Minimum Management Experience: 3 years of management experience.
Minimum Quality Experience: 5 years of quality experience in pharmaceutical, medical device or other related industries.
Strong written and verbal communication skills.
Some exposure to regulatory agency inspections (e.g. FDA, notified bodies, etc.).
Proven ability to work cross-functionally to achieve business outcomes.
Job Type: Full-time
Required education:
Bachelor's
Required experience:
management: 3 years
Job Type: Full-time
Required education:
Bachelor's
Required experience:
Quality Assurance: 1 year
management: 3 years
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