QA Specialist

Job Title: QA SpecialistLocation: Groveport, OHRate: $26-28/hr. + BenefitsShift: Mon-Fri | 7am-3:30pmPOSITION SUMMARYThis position is responsible for providing support to the Quality Assurance group, to include the inspection, sampling and testing of products.MAJOR RESPONSIBILITIESSupports the Distribution Center operation:Sampling and testing of bulk and packaged productsOccasional testing of labels, components, and packaging materialsMaking product status changes (Quarantine, Hold, Release, and Reject) as required.Witnessing and documenting product destruction as necessaryReviewing contract manufacturer Certificates of Analysis (CofAs) and Certificates of Manufacture for release of productMaintaining packaging equipment documentation and log booksMaintaining all related documentation for each product evaluation and ensure that all logs and databases are correctCreating and maintaining FDA required reserve samplesTraining new employees on approved QA SOPsCreates, writes and/or revises SOPs and Batch Records as needed to maintain compliance with all related FDA, etc. regulationsInteracts daily with cross-functional teams within Shaklee to gather information and understand product timelinesMaintains all QA systems related to regulated activities within the facility and all associated documentation, with particular attention to those QA/QC activities related to the receipt, inspection, testing, packaging, assembly, storage and distribution of regulated products and their packaging components:Tracking and updating employee trainingIssuing and tracking variances, including closure and completion of corrective and preventative actionsIssuing and tracking equipment logsControlling and updating issued SOP and Form bindersProcessing and issuing approved Groveport Work InstructionsRoutinely reviewing the pest control recordsMaintaining facility housekeeping recordsConducts investigations as required:Issuing and tracking Non-conformance reports, including closure and completion of corrective and preventative actionsIssuing deviations for product releaseProvides support for the packaging process:Performing line clearancesPerforming in-process inspectionsReviewing documentation regarding line cleaning and set upPulling packaging samples for inspection and reconciliation involving quantities, proper assembly, complete seals and quality defectsRelease of packaged product in the inventory control systemCreates and revises work instructions for the warehouse operationsDay-to-day support of the distribution center:Monthly Facility Audits (exterior and interior)Cleaning and maintaining Packaging RoomEquipment and environmental swabbing and testingLine-Clearances for Packaging RoomAttends meetings to communicate with facility management, QA management, Planners, and/or cross-functional teams, when a product issue arises.POSITION REQUIREMENTS Listed in order of importance3-5 years related experience in a regulated industry preferred2-3 years of QA/QC experienceEffective writing and interpersonal communication skillsAbility to effectively use MS Word, Excel and Access (preferred)Organized with specific attention to detail skillsAbility to travel up to 2% domestically for training

Created: 2024-11-10