Quality Assurance Inspector

Job DescriptionJob DescriptionPrincipal Duties and Responsibilities of The PositionGeneralMonitor all GMP activities in assigned areas and throughout Gemini facilities.Monitor temperature and humidity in all production and warehouse areas throughout Gemini facilities.Perform room clearance checks throughout manufacturing and packaging areas.Have basic familiarity with equipment used in the manufacturing and packaging of pharmaceuticals.Perform room clearance checks of manufacturing, and packaging rooms as applicable.Perform daily inspection checks to pest control stations.Perform daily scale checks.Ensure product quality, through visual inspection of goods in accordance with the ANSI/AQL sampling standard and requirements to determine a final disposition of finished bulk and/or packaging components.Should be able to wear filtering facepiece (dusk mask, surgical mask, respirator) throughout the day.Conduct Special Projects and or perform other functions as instructed by Quality Assurance Management. PharmacyEnsure raw materials are received, sampled, and status control per procedure.Monitor Sampling and Pharmacy operations.Creation of raw material inventory cards upon QC release of materials. ManufacturingPerform manufacturing checks of raw materials, product blends and capsule shells at set up as well as throughout manufacturing runs.Perform manufacturing checks during compression process, and limited to weight, hardness, thickness, and physical appearance checks.Perform manufacturing checks during encapsulation process, including but not limited to weight check, and physical appearance checks.Perform manufacturing checks during coating process.Pull test samples for Quality Control LaboratoryPerform process checks during bulk inspection process. PackagingPerform verification of packaging components at the line set up as well as throughout the packaging run.Perform verification of packaging components at the line set up as well as throughout the packaging run.Perform labels and carton conformation checks at start up as well as during packaging runs.Performs half-hour checks on products during the packaging process, including but not limited to: Label checks, cotton checks, barcode checks, product count, product name, proper seal etc.Performs clean room checks every hour to ensure there are no pills on the floor, no extraneous packing debris, or spillage.Pull Packaging retain samples. ReceivingSampling, Inspection, and Release of Component Materials; status monitoring of componentsReview packaging component inventory forms for accuracy and completion; resolve inventory discrepancies; approve and close out forms.Perform in-process inspection checks in the inspection department.Required Skills and Experience Strong verbal and written communication skillsStrong organizational skills and ability to prioritize and multi-task.Excellent analytical, problem-solving, and decision-making skillsPhysical Requirements – ability to bend, twist, reach, climb ladders, lift materials up to 50 lbs.Must have good vision, aided by glasses, if necessaryMust successfully pass the Color-Blind Test as (normal color vision)Additional SkillsBilingual is a plus.Experience in a pharmaceutical/ Food Safety (HACCP) environment preferred.Quality training or equivalent continuous improvement experience preferred.In-depth knowledge of cGMPs, FDA, CFR requirements OSHA, fire and general safety preferred.