QA PRODUCT MANAGER

PRIMARY PURPOSE:

• Provide customer service and serve as primary QA point of contact for customers.
• Review and approve quality documents for customers such as Deviations, Master Batch Records, Change Controls, Validation Protocols and Reports, FG specifications and Test Methods.
• Coordinate required functions across the site and with customers to ensure timely review and approval of deviations, change controls, audits CAPAS, corrections and effectiveness checks.
• Develop Technical Quality Agreements and collaborate with customers to align customer and FS quality systems.
• Develop and nurture customer partnership to ensure alignment and consensus.
• Participate and coordinate meetings with customers as part of QA oversight for customer products.
• Generate quality metrics, trackers, and reports for management and customers to characterize the health of the client relationship and state of quality systems.
• Promote Compliance within the site at all levels and cross functional Teams.
• Participate in the Internal Audit Program by performing site audits as required by QA Management.
• Provide support during customer audits and Health Authorities inspections.
• Support EHS audits (regulatory and customers) to scribe- file documents as required.
• Conduct Investigations/CAPAs for quality events, ISO event, calibration events and safety quality related events as required by management.
• Promote GMP and safety throughout the facility by training and coaching personnel to quality, regulatory and safety as tasked.
• Accurately reviews and records data.
• Promote continuous improvement and customer satisfaction.
• Participate in other activities as assigned by the Director of QMS.

QUALIFICATIONS:

• Experience working in Quality Assurance, QMS, Validation and Compliance.
• Experience in a regulated industry (e.g., Food and Drug Administration).
• Bachelor's Degree in Science (Chemistry, Microbiology or Biology preferred) required
• A minimum of five to ten years related experience and/or training and/or equivalent combination of education and experience in the QA pharmaceutical industries.

CRITICAL SKILLS AND ABILITIES:

• Working knowledge of FDA regulations for drugs and/or medical devices.
• Skill in written and oral communications and in establishing effective interpersonal relationships.
• Ability to use a personal computer and peripheral equipment to accurately enter and analyze data and produce reports.
• Ability to make quality decisions and act accordingly.
• Ability to establish priorities, work independently, productively, and proceed with objectives without supervision.
• Ability to perform effectively under conditions of fluctuating workload.
• Ability to handle and resolve recurring problems.
• Communicate with others clearly and concisely.
• Ability to work in a fast-paced environment - sometimes rapidly shifting priorities. Ability to concentrate in such an environment and perform quality work.
• Strong initiative, technical commitment and contribution to company and departmental goals