QA Assistant Über die Tätigkeit Candidate will work with Quality Assurance as a Quality Assistant to ensure compliance of manufacturing processes in a GMP environment. This person will serve as reviewer and/or approver for required documentation in a plant setting. This position is very project orientated, so the QA Assistant can expect every day to be different with changing responsibilities and priorities. QA AssistantResponsibilitiesReview Certificate of Analysis for incoming goods and verify associated documentationVisually inspect all incoming goods to ensure that the packaging is not damaged, and that quality of the product is not compromised by the condition of the packagePhysically inspect packaging components to ensure all items meet quality standardsSample incoming goods (packing components and Active Pharmaceutical Ingredient)Send samples of API to third party lab for testingTrack status of API samples sent to third party lab for test resultsReview lab test results to ensure that sampled products meet quality standardsRelease products and API that meet quality standardsUse AX to complete checklists and input data as neededRevise and create SOPs for incoming quality processesInitiate investigations for Incoming QualityCommunicate and collaborate with Supply Chain, Production, Quality, and Quality Control on all Incoming Quality processes and the release status of raw materials tested for qualityData entry for raw material test results, incoming material inspection reject rates, and supplier qualification and management.New item setup in AX.Conduct facility and/or supplier assessments, raw material release, and line clearancesAuthor and update SOPs as neededFollow GMP guidelines and adhere to SOPs and GMP requirementsCommunicate QA issues to employees and managers in a tactful mannerWork on multiple projects at once with changing deadlines and priorities Ihr Profil RequirementsBS in science or 2-6 years of applicable experienceExperience working in a laboratory or process manufacturing settingExperience working in a regulated environment (GMP)Detail oriented, ability to get along with a variety of different personalities, multitasking skills, and works well under pressureStrong verbal and written communication skillsTechnical writing and review abilityDesire to work in an office setting as this position is not laboratory focused Mail-a-friend Stellenangebot weiterleiten: