Quality Inspector

Job Description

The Quality Assurance Inspector (QAI-Level 1) holds responsibility for ensuring Good Manufacturing Practice (GMP) compliance across all Gemini facilities. This role encompasses the receipt and control of incoming components, as well as ongoing inspections at setup, during, and upon completion of manufacturing and packaging processes, in accordance with established company procedures and FDA regulations. The inspector performs these duties under the guidance of the Quality Assurance Manager.

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 at 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 a 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 setup as well as throughout manufacturing runs.

• Perform manufacturing checks during the compression process, 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 the coating process.

• Pull test samples for Quality Control Laboratory

• Perform process checks during the bulk inspection process.

Packaging

• Perform verification of packaging components at the line setup as well as throughout the packaging run.

• Perform verification of packaging components at the line setup 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 multitask.

• 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 (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.