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Grand River Aseptic Manufacturing, Inc QA Specialist all shifts in Grand Rapids, Michigan

DescriptionuJOB SUMMARY/uSupport the quality systems as they relate to the manufacturing and testing of cGMP drug products. Provide quality oversight for terminal sterilization, visual inspection, labeling and packaging Operations of parenteral drugs. Perform the quality release of incoming materials. Review documentation and quality records.uESSENTIAL DUTIES RESPONSIBILITIES/uulliVerify compliance with terminal sterilization, visual inspection, labeling and packaging operations documentation during operations/liliReview executed batch records and other associated controlled documents/liliPerform clearances and start-up activities associated with Finishing Operations and Weigh and Dispense Booth operation./liliPerform QA review and approval of stability and finished products testing certificates of analysis/liliPerform QA review and material release for incoming materials/liliPerform routine tasks within the quality systems, such as Work Orders, Calibration Forms, etc./liliUnderstand and be able to perform job responsibilities in compliance with cGMPs, company standard operating procedures, and industry best practices./liliParticipate in deviation investigation teams to support quality investigations (NCRs, LIRs etc.)/liliOpen to a flexible and fluid work environment./liliSupport Agency, customer and vendor audits as needed./liliResponsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices./liliPerform all other tasks, projects, and duties as assigned./liliIdentify and suggest areas for improvement./li/ulRequirementsuDESIRED SKILLS ABILITIES/uulliAbility to complete tasks with accuracy and efficiency./liliAbility to understand quality standards./liliPortrays appropriate levels of integrity and professionalism./liliBasic written and verbal skills; Ability to communicate with management and staff./liliEnergetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment./liliResults oriented and efficient./liliCreative and open-minded individual who fosters an environment in which sharing of ideas is encouraged./liliDevelop an understanding of the decision making process and begin to build confidence in decision making ability./liliAbility to work independently and in a cross-functional team environment./liliMust have basic computer skills such as Microsoft Word, Excel and Outlook./li/ulQualified candidates have knowledge of QA principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment. This level of knowledge is normally acquired through completion of a Bachelor's Degree in Life Sciences or related field, and 1-2 years related work experience. In lieu of a Bachelor's Degree, equivalent GMP/related work experience may be considered.BR/GRAM supports Equal Opportunity Employment

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