Incoming Quality Control Operator

Ferndale Pharma Group•Warren, MI

5d•Onsite

About The Position

Ferndale Laboratories, Inc. is currently seeking a Incoming Quality Control Operator (IQC Operator). The Incoming Quality Control Operator (IQC) is required to follow written procedures, current company policies and procedures, and current Good Manufacturing Practices (cGMPs). The jobholder is required to utilize these policies, procedures, and cGMPs to inspect and sample raw materials, components, and finished products. The jobholder is expected to immediately notify Quality Assurance management of any deviations the jobholder becomes aware of. The jobholder must be able to quickly and concisely relate inspection/sampling information, as the work performed by the jobholder directly impacts other departments. Quickly and accurately completes sampling and inspection activities of incoming raw materials, packaging components, finished products, bulk products and contracted manufactured products per written, approved specifications. Uses proper sampling techniques to sample raw materials for submission to the Quality Control Laboratory for testing. Must use aseptic sampling techniques to ensure samples/containers for microbial testing are not compromised. Must be able to handle inspection activities with the highest degree of accuracy. Assures proper safety techniques are used during sampling. Inspect FLI products for yearly review of product integrity. Determines sample quantities per written, approved procedures and pulls appropriate amounts for inspection. Uses handheld measuring devices such as rulers, calibers and must be proficient in basic mathematical techniques. Performs equipment and room inspections. Keeps IQC Supervision informed of any quality issues surrounding incoming raw materials, components and contract manufactured products. Maintains calibration schedules of scales, calipers, & gauges.

Requirements

Working knowledge of Food and Drug Administration (FDA), regulations and cGMPs.
Familiarity with American National Standard Z1.4 or equivalent sampling plans.
Basic computer skills, including knowledge of word processing, spreadsheet and database management.
Self-motivated, detail oriented and accurate with good written and verbal communication skills.
Valid driver's license.
Proficiency in basic mathematical techniques.
Experience with hand-held measuring devices, such as rulers, calipers, etc.; sampling devices; pallet jack and scales.
Ability to lift approximately 50 lb. manually.
Ability to move raw material/component pallets using a pallet jack.
Ability to move full drums using a drum dolly and use a drum roller.
Ability to stand for prolonged periods of time.
Ability to use respirators.
High School diploma or equivalent.
Demonstrated strong mathematical skills.
Onboarding requires a pre-employment drug screen/physical (10-panel test including marijuana) and criminal background checks.

Nice To Haves

Experience in Pharmaceutical or related industry experience helpful.

Responsibilities

Inspect and sample raw materials, components, and finished products.
Immediately notify Quality Assurance management of any deviations.
Quickly and concisely relate inspection/sampling information.
Complete sampling and inspection activities of incoming raw materials, packaging components, finished products, bulk products and contracted manufactured products per written, approved specifications.
Use proper sampling techniques to sample raw materials for submission to the Quality Control Laboratory for testing.
Use aseptic sampling techniques to ensure samples/containers for microbial testing are not compromised.
Handle inspection activities with the highest degree of accuracy.
Assure proper safety techniques are used during sampling.
Inspect FLI products for yearly review of product integrity.
Determine sample quantities per written, approved procedures and pull appropriate amounts for inspection.
Use handheld measuring devices such as rulers, calibers and must be proficient in basic mathematical techniques.
Perform equipment and room inspections.
Keep IQC Supervision informed of any quality issues surrounding incoming raw materials, components and contract manufactured products.
Maintain calibration schedules of scales, calipers, & gauges.
Support schedule commitments with minimum supervision through organizing and planning work assignments and teamwork.