Overview/Risks

The Supervisor- QA Release responsibilities will include the daily management of Quality Assurance Release Specialists and Analysts. It will also be the responsibility to ensure that the daily Quality Assurance functions of: 1) Review, release, and rejection of tissue and medical devices for inventory, 2) Tissue HOLD process; 3) Tissue and medical device testing compilation; 4) goals and strategic metrics are performed efficiently, correctly, timely, and in compliance with MTF specifications and all governing regulatory and industry standards bodies. Other quality responsibilities include document control approvals/reviews, procedure writing, collaboration with business units, and input for product/process improvement teams.

Responsibilities

• Actively manages QA personnel in the daily functions including; review of processing and testing records; and release and rejection of tissue and medical devices according to current SOPs and Work Instructions, finished good (FG) specifications and in-process finished goods (IFG) specifications, in accordance with applicable regulatory requirements. Ensures schedule attainment.
• Actively manages QA personnel by completing performance evaluations, performance management/feedback, bonus/merit recommendations, and training/competency files
• Meet with employees 1: 1 on a routine basis to promote job enrichment and goal obtainments. Conduct team meetings to keep the team well informed of current goals and any relative information to promote a teamwork environment.
• Interacts with internal MTF departments and business units to organize, review and analyze data pertaining to the release of tissue and medical devices in compliance with MTF procedures, product specifications, and applicable regulatory requirements
• Investigates, performs root cause analysis, provides evidence, and verification of effectiveness of actions related to NCRs, CAPA, audit findings, improvements and trends requiring action of all activities associated with the QA functions above
• Perform observations to ensure adherence to procedure and policy, identifies and implement process improvements.
• Initiates, approves and completes impact assessments in the change management system
• Ensure audit ready functions and supports internal/ external audits.
• Create and revise operating procedures and work instructions and forms in EDMS
• Interview, hire and assist with new employee development and training.
• Maintain working knowledge of the processes he/she is responsible for
• May provide back-up support in the absence of another Supervisor
• Performs additional duties, as assigned 

Qualifications

• Bachelor's Degree
• 3 years Quality Assurance or Manufacturing related experience
• 2 years Supervisory experience in a GMP regulateed industry
• Must be able to supervise employees in a fast paced environment
• Must be proficient in data entry, Microsoft Outlook, Word, and Excel
• Must exhibit attention to detail, organizational, critical thinking, problem-solving, People management, and effective communication skills.