Job Description
Description:
Job Duty:
Perform in-process evaluations of production processes and controls. Document accurately in the batch record, reviewing visual processes of manufacturing area personnel. Verifies all components, raw materials, and in-process materials are accurate and meet the batch record requirements. Perform line clearances and shift verifications to ensure the processing is at all times in a state of control. Documents and or verifies inspection results in the batch record as required. Perform visual and statistical sampling and document verifications, ensuring all met the approved specifications and guidelines indicated in the batch record.
Completes the documentation for retains and storage processes of in-process material and finished goods. Review batch production records for accuracy and completeness. Performs the final compliance review and approval of all batch documentation. Assures that the release of final product and batch records meet processing and testing requirements, specifications, policies, and procedures before final product release. Recognizing non-conformances and reporting them immediately.
Obtain and retain samples as needed for Quality Analysis (Lab). Perform swab tests and any other tests to guarantee product compliance. Make sure special instructions, if any, are being followed. Responsible for the proper documentation of any quality issues.
Responsible for properly and immediately identifying any product with a perspective issue and controlling the quarantined product on the floor. Performs daily scale verifications. Performs daily visual inspections of assigned areas for cleanliness and safety hazards. Assure logbooks in all areas are completed and reviewed.
Perform OJT Quality Training as needed. Work closely with QC Management to ensure that deviations are received, if needed, in a timely manner to minimize downtime to production processing.
Strict enforcement of GMP/ cGMPs, SOPs, and CFR 21 Part 111. All other duties assigned.
Requirements:Education:
Associate degree or equivalent experience
One to three years of experience in the Quality Control pharmaceutical or dietary supplement industry is preferred.
5 or more years’ experience in a manufacturing/production environment.
Working knowledge of spreadsheet and word processing software, i.e., Excel and Word. Solid time management and verbal skills are required to effectively relate potential problems to production personnel and management. Must be able to perform calculations and use measuring instruments. Excellent communication, interpersonal skills, and strong team working skills. Should be able to think and operate independently.
Must be able to read, write, and speak English.
Bilingual English and Spanish a plus.
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