What are the responsibilities and job description for the Quality Assurance Inspector position at Gemini Pharmaceuticals Inc?
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.
Salary : $22 - $25