SUMMARY: Responsibilities include supervision of incoming Quality Assurance activities and providing directions for cGMPs to direct reports. The QA Incoming Inspection Supervisor will have frequent contact with QA representatives from customers and vendors as well as internal Operations, Sales, Materials Management, Engineering and Quality Assurance associates concerning incoming inspection activities. Participate in audits by customers and other regulatory agencies. Scope of the position includes the Quality Assurance incoming inspection function at the local site. The impact of decisions relating to customer interface, quality inspections, and documentation requirements could expose the company to significant risk or economic loss. ESSENTIAL DUTIES AND RESPONSIBILITIES: The all-inclusive list of responsibilities may be distributed to multiple supervisors. Other duties may also be assigned. Responsible for the management of assigned subordinate Inspectors, including but not limited to: ● Training, scheduling and assignment of staff to meet all incoming inspection requirements. ● Oversight of Inspector operations to ensure timely review and disposition of incoming materials (including bulk products, raw material and components) ● Completion of annual performance reviews. ● Managing disciplinary action issues in conjunction with manager. ● Completion and documentation of subordinate training. Responsible for the incoming inspection process of DEA classified drugs, other drug products and medical devices. Responsible for the identity testing of containers and closures (films, foils, pouches, bottles, caps, etc.) used in the packaging of the company’s products. Responsible for overseeing the reject cage and supporting efforts to review and disposition nonconforming bulk products, components and materials. Responsible to ensure and enforce GMP compliance (including but not limited to gowning attire, personnel hygiene, handling/storage of materials and good documentation practices) throughout the inspection and warehouse areas. Responsible for processing applicable DMR’s (Deviated Material Reports), Investigations and any other applicable Quality Systems associated with QA Incoming Inspections. Responsible for maintaining bulk products, component and raw material specification and inspection files. Draft, review and revise SOP’s and specifications on a designated basis to ensure accuracy. Responsible for participating in internal and external audits at the discretion of management. Responsible for follow-up on audit observations specific to the related areas. Responsible for reporting departmental metrics to senior management monthly. Responsible for overseeing the Pest Control program for all applicable facilities. Responsible for assuring all test equipment is within the calibration due dates. Capable of using measuring tools, i.e. calipers, rulers, micrometers, etc. Capable of using the FTIR and Global Vision System to perform inspections on films, foils and printed components. Assist in appropriate problem-solving initiatives to address customer or regulatory quality issues as requested by Senior Management. REQUIREMENTS: Due to the nature of our work, all employees must be over the age of 18 and will be required to undergo a pre-employment drug test and background check.