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.
Monday- Friday 8:15am - 4:30pm
Salary Range $67,727.04 - USD $78,408.80/Yr.
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.
Be Accountable
Actively manages QA personnel by completing performance evaluations, performance management/feedback, bonus/merit recommendations, and training/competency files
Work Together
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.
Deliver Exceptional Service
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
Make It Happen
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
Think Smart
Perform observations to ensure adherence to procedure and policy, identifies and implement process improvements.
Be Accountable
Initiates, approves and completes impact assessments in the change management system
Think Smart
Ensure audit ready functions and supports internal/ external audits.
Make It Happen
Create and revise operating procedures and work instructions and forms in EDMS
Be Accountable
Interview, hire and assist with new employee development and training.
Deliver Exceptional Service
Maintain working knowledge of the processes he/she is responsible for
May provide back-up support in the absence of another Supervisor
Make It Happen
Performs additional duties, as assigned
Degree/Diploma Program of Study Equivalent
Bachelors
Minimum Years of Experience Area of experience
3 Years Quality Assurance or manufacturing related experience
2 Years Supervisory experience in a GMP regulated industry.
At MTF Biologics we provide comprehensive benefits and resources to support our employees physical, emotional, and financial health.