Quality Assurance Inspector

Job Description

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.

M anufacturing

• 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.