The Incoming Quality Assurance (IQC) Operator 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, contract products, and retained finished products. The jobholder is expected to immediately notify Quality Assurance management of any deviations the jobholder becomes aware of. The operator must be able to quickly and concisely relate inspection/sampling information because the work performed by the jobholder impacts other departments. The jobholder may be required to train other IQC operators, assist other Departments, or assist in conducting standard operating procedure training.
Quickly and accurately completes sampling and inspection activities of incoming raw materials, packaging components and contracted manufactured products.
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.
Assures proper safety techniques are used during sampling.
Determines sample quantities per written, approved procedures and pulls the appropriate amounts for inspection.
Performs and documents incoming inspections per written, approved specifications.
Keeps IQC Supervision informed of quality issues surrounding incoming raw materials /components /contract manufactured products.
Perform yearly inspections of finished products.
Working knowledge of Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), International Organization for Standardization (ISO) regulations and cGMPs.
Must be familiar 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.
Proficiency in basic mathematical techniques.
Experience with hand-held measuring devices, such as rulers, calipers, etc.; sampling devices; pallet jack and scales.
The jobholder must be able to lift approximately 50 lb. manually, be able to move raw material/component pallets using a pallet jack, move full drums using a drum dolly and use a drum roller, and wear a respirator as needed. Sampling activities may require standing for prolonged periods of time.
Supports schedule commitments with minimum supervision through organizing and planning work assignments and teamwork.
Requires a high school diploma or equivalent.
EO Employer M/F/Vets/Disabled
Medical, dental, vision, 401k with company match, vacation and holiday pay.