Performs and leads activities in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and company Standard Requirement Documents.
• Represent Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution.
• Represents the IOPS organization on behalf of QA with external partners to communicate IOPS QA policy and procedures; liaise with external partners and provide input on regulatory communications.
• Train and/or mentor employees, including providing insights and education on processes and procedures, and conveying expectations of QA organization.
• Provides consultation or advice in alignment with QA policies.
• Perform activities associated with disposition of raw materials and product (e.g., manufacturing record review, receipt, inspection, document review, shipping, etc). Activities may be on the floor or at a desk.
• Review, edit, or approve company controlled documents.
• Review and approve investigations associated with raw materials, product, laboratory, or facilities.
• Perform status labelling of raw materials and product.
• Continually evaluating company processes and procedures with an eye toward continuous improvement.
• Bachelor’s degree in Engineering, Chemistry, or Life Sciences with 5+ years of related experience within the fields of computers and biotechnology for the Specialist level, 5+ years’ experience for Senior level.
• Experience with IT/Automated Enterprise systems desirable. Will substitute relevant experience for education. Level is determined based on qualifications relevant to the role.
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