Coordinate Product Release functions and assign daily tasks to Product Release personnel.
• Perform in-depth evaluation of the Device History Record (DHR) based on criteria in the Device Master Record (DMR) and applicable Standard Operating Procedures (SOPs) by auditing the electronic system and representative sample and obtain any additional documentation and signatures needed.
• Interface with other departments to help identify, clarify, and resolve documentation issues or nonconformances with Device History Records and representative sample documentation.
• Prioritize backorders batches and notify if any problem which holds the product to be released.
• Ensure compliance of Product Release personnel with training curriculum.
• Discuss with QA Techs II and QA Techs I all important information and issues concerning the QA Department.
• Prepare monthly reports of Product Release Area.
• Work with Product Inventory Control concerning release schedules and with Warehouse/Traffic concerning product shipment.
• Communicate observations or changes on applicable SOPs.
• Observe safety precautions and maintain good housekeeping within area and encourage the involvement of employees Safety activities.
• Provide feedback on the performance of Product Release personnel.
• Assist in the dissemination of the management goals and the objectives.
• Observe and maintain Good Manufacturing and Documentation Practices.
• Update and maintain daily report to track all batches received in the department.
• Environmental, Health & Safety (EHS): Must observe all federal, state, and company EHS policies and regulations. Must follow the proper indications established in the related EHS SOP’s. Follows and support all guidelines established in the organization for the implementation and continuous improvement of the EHS and BEST program.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
• Other duties as assigned with or without accommodation.
MINIMUM REQUIREMENTS:
Education required/ preferred: Bachelor degree or equivalent
Experience preferred: 1 year or more in Quality System functions in a FDA regulated industry
Preferred Skills/Qualifications:
• Supervisory skills.
• QA Product testing, line audit and documentation knowledge.
• Technically and people oriented.
• Ability to use and operate office equipment.
• Computer literate.
Skills/Competencies: Action Oriented, Creativity, Customer Focus, Decision Quality, Ethics & Values