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Perrigo External Quality Supervisor - First Shift in Allegan, Michigan

bPerrigo/bbr/br/Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold. Help us do it.Please note this is a first shift position, but has direct reports on first, second, and third shifts. Flexibility in work hours will be required in order to keep in touch with all direct reports on off-shifts.The External Quality Supervisor is responsible to ensure that company products meet defined quality standards through supervision of product auditing and product release processes, as well as for the staff completing the auditsrocesses.Major Duties / Responsibilities will include:ulliDevelops and maintains auditing methods which ensure identity control in raw materials, packaging, manufacturing and finished goods, with approval of final release of product for shipment./li/ululliReviews and approves controlled documents, including SOPs, SWIs (Standard Work Instructions), Job Aids, SCRF (SAP Change Request Form), SBRF (Split Batch Request Form), RWand#8217;s (Rework) Notifications, planned deviations, and ORAFand#8217;s (Operational Risk Assessment Form)./li/ululliPerforms risk assessment and containment for Quality Events./li/ululliIdentifies any non-conformances or variances, recommends corrective action, and ensures follow up actions are taken by working with staff and management in those areas./li/ululliManages/trains Technician staff to ensure that all documentation meets cGMP and FDA standards. Selects, mentors, and evaluates performance of Technician staff./li/ululliAssists with FDA inspections as requested and ensures FDA readiness in Operations. Also, assists with 3suprd/sup party Audits (Customer, Contract)./li/ululliManages day to day work load of Technician staff and manages shifting priorities to support internal external customers, and Initiate and Executes and oversees projects as required./li/ulRequirements and Qualifications:ulliHigh School Diploma or GED is required. Bachelorand#8217;s or Associateand#8217;s degree, within a scientific discipline, strongly preferred./li/ululliMinimum of three (3) years of experience working in an FDA regulated industry, including a minimum of one (1) year in a QC/QA role and some previous supervisory experience, will be required./li/ululliGood oral and written communication skills, and excellent interpersonal skills./li/ululliDemonstrated ability to interpret and apply FDA regulations relevant to company processes, and a familiarity with quality assurance, release methods, auditing, risk assessment and SAP./li/ulbr/br/Equal Employment Opportunity/M/F/disabilityrotected veteran status. img src="https://analytics.click2apply.net/v/k5lnWwCO5E8EFMQh47x4" brbrPI128339050

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