QA PRODUCT MANAGER

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    "requisitionDescription": "<div><div><p id=\"isPasted\"><strong>PRIMARY PURPOSE:</strong></p><ul><li>Provide customer service and serve as primary QA point of contact for customers.</li><li>Review and approve quality documents for customers such as Deviations, Master Batch Records, Change Controls, Validation Protocols and Reports, FG specifications and Test Methods.</li><li>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.</li><li>Develop Technical Quality Agreements and collaborate with customers to align customer and FS quality systems.</li><li>Develop and nurture customer partnership to ensure alignment and consensus.</li><li>Participate and coordinate meetings with customers as part of QA oversight for customer products.</li><li>Generate quality metrics, trackers, and reports for management and customers to characterize the health of the client relationship and state of quality systems.</li><li>Promote Compliance within the site at all levels and cross functional Teams.</li><li>Participate in the Internal Audit Program by performing site audits as required by QA Management.</li><li>Provide support during customer audits and Health Authorities inspections.</li><li>Support EHS audits (regulatory and customers) to scribe- file documents as required.&nbsp;</li><li>Conduct Investigations/CAPAs for quality events, ISO event, calibration events and safety quality related events as required by management.</li><li>Promote GMP and safety throughout the facility by training and coaching personnel to quality, regulatory and safety as tasked.&nbsp;</li><li>Accurately reviews and records data.&nbsp;</li><li>Promote continuous improvement and customer satisfaction.&nbsp;</li><li>Participate in other activities as assigned by the Director of QMS.</li></ul><p>&nbsp;<strong>QUALIFICATIONS:</strong></p><ul><li>Experience working in Quality Assurance, QMS, Validation and Compliance.</li><li>Experience in a regulated industry (e.g., Food and Drug Administration).</li><li>Bachelor&rsquo;s Degree in Science (Chemistry, Microbiology or Biology preferred) required</li><li>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.</li></ul><p><strong>&nbsp;</strong><strong>CRITICAL SKILLS AND ABILITIES:</strong></p><ul><li>Working knowledge of FDA regulations for drugs and/or medical devices.</li><li>Skill in written and oral communications and in establishing effective interpersonal relationships.</li><li>Ability to use a personal computer and peripheral equipment to accurately enter and analyze data and produce reports. &nbsp;</li><li>Ability to make quality decisions and act accordingly.</li><li>Ability to establish priorities, work independently, productively, and proceed with objectives without supervision.&nbsp;</li><li>Ability to perform effectively under conditions of fluctuating workload.</li><li>Ability to handle and resolve recurring problems.</li><li>Communicate with others clearly and concisely.</li><li>Ability to work in a fast-paced environment &ndash; sometimes rapidly shifting priorities. Ability to concentrate in such an environment and perform quality work.</li><li>Strong initiative, technical commitment and contribution to company and departmental goals</li></ul></div></div>\n",
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