Quality Assurance Inspector
2 months ago
Commack
Job Description Principal Duties and Responsibilities of The Position General • Monitor 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. Pharmacy • Ensure 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. Manufacturing • Perform 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 Laboratory, • Perform process checks during bulk inspection process. Packaging • Perform 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. Receiving • Sampling, Inspection, and Release of Component Materials; status monitoring of components, • Review 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 skills, • Strong organizational skills and ability to prioritize and multi-task., • Excellent analytical, problem-solving, and decision-making skills, • Physical Requirements – ability to bend, twist, reach, climb ladders, lift materials up to 50 lbs., • Must have good vision, aided by glasses, if necessary, • Must successfully pass the Color-Blind Test as (normal color vision) Additional Skills • Bilingual 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.