Quality Supervisor

To supervise the activities of quality staff responsible for developing and implementing quality programs in accordance with applicable requirements, Standard Operating Procedures (SOPs), Good Laboratory Practices (GLPs, current Good Manufacturing Practices (cGMPs) and in compliance of ISO 17025 to ensure integrity and consistency of quality systems and training.

Full responsibility for supervising assigned quality staff.  This includes hiring, coaching, scheduling/delegating work, conducting performance reviews and determining pay/ promotions. Responsible for insuring all staff is in compliance with SOPs and Iso standards.

Essential Duties and Responsibilities:

• Applies ISO17025/cGMP/GLP in all areas of responsibility, as appropriate
• May be required to assume responsibilities of Quality Director in the absence of the Quality Director.
• Coordinates with multiple locations and Business Units
• Develops appropriate training plans and ensures staff are trained
• Assists with performance evaluations, staffing decisions and other supervisory activities for the assigned functional group
• Trains and mentors staff, sharing expertise in quality compliance
• Schedules staff and assigns resources
• Compiles and communicates corporate quality metrics
• Conducts internal audits, both Technical and QMS
• Generates management review reports and facilitates management review meetings
• Develops and implements SOPs
• Determines SOP applicability, peer reviews SOPs and other controlled documents
• Identifies process improvement opportunities, recommends solutions, and implements action plans to improve quality
• Manages proficiency testing (PT) schemes, scheduling, reporting results, updating PT database and communicating results to operations
• Participates in external audits and evaluates responses to audit reports
• Manages customer feedback/ complaints
• Manages non-conformity documentation, creating, completing, reviewing and approving where applicable
• Ensures complaint and non-conformity documentation remains under control through periodic communicating of status/metrics to operations.
• Manages vendor/ subcontractor qualifications
• Generates other quality metrics as required (e.g. change control / control chart / OOS / standard/reagents etc.)
• Performs monthly review of USP updates (USP-NF & Standards) and communicates to operations
• Performs other duties as assigned