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Grand River Aseptic Manufacturing, Inc Labeling, Packaging, Inspection Supervisor 2nd Sh in Grand Rapids, Michigan

DescriptionuJOB SUMMARY/uSupervise multi-finishing operations of parenteral liquid drug products. All activities must comply with cGMP's and regulatory requirements. The position requires employee supervision to ensure products comply with cGMP's, SOP's, and batch record instructions, and also that labor and material standards are met. Ensure that planned production occurs on time to meet the forecasted schedule. The individual must have the requisite technical skills to supervise both manual and automated processes in a pharmaceutical or FDA regulated environment and must have the ability to make informed decisions. Must be able to work overtime and some weekends; 2nd shift premium available.bruESSENTIAL DUTIES RESPONSIBILITIES/uulliSupervise all Finishing activities for small and/or large volume parenteral liquid drug products./liliEffectively coordinate activities by communicating with other operational departments./liliEnsure adequate levels of operating supplies to meet production needs./liliTrain staff on good safety practices and enforce all safety regulations./liliWrite and/or revise departmental procedures and batch records for their corresponding department./liliAssist with training employees in all departmental procedures, product inspection and cGMPs/liliPractice good housekeeping techniques/liliAccurately document data and complete batch records as needed./liliAssist in the scheduling and performance of routine maintenance of production equipment./liliParticipate in client communications, including problem solving, schedule development, and project status updates./liliDefine and uphold disciplinary actions for poor performance of direct reports, as necessary./liliFoster a positive team environment that promotes productivity and employee satisfaction/liliActively participate in Continuous Quality and Safety Improvements./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./li/ulbrRequirementsuDESIRED SKILLS ABILITIES/uulliExperience in pharmaceutical packaging of regulated products with a thorough understanding of cGMP, FDA guidelines and multinational regulatory standards is preferred./liliAbility to interpret and relate Quality standards./liliMust be detail oriented./liliStrong verbal and written communication skills./liliKnowledgeable of GMP standards and the ability to follow CFR guidelines./liliComputer proficient and familiar with Microsoft applications./liliExcellent time management skills./liliResults oriented and efficient./liliCreative and open-minded who fosters an environment in which sharing of ideas is encouraged./liliAbility to work closely with a diverse team./liliAbility to work well in a cross-functional team environment./li/ulQualified candidates possess a Bachelor's degree in life sciences or equivalent training and/or experience in a related environment. Minimum of 1-year experience as a qualified inspector of parenteral products preferred. Two to five (2-5) years of relevant experience in pharmaceutical or FDA regulated industry. Available for off-shift and/or on-call work, as needed.brbrlt

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