Job Description

Job Description: Materials and product inspections and releases; document reviews and approval, pulling of samples, reporting of nonconformance, monitoring of GMP compliance.

Job Responsibilities:

  • Gives work assignments to area inspectors and resolves issues.

  • Performs duties related to documentation creation, document review and approval, identification and communication to management of non-conforming materials and products; cGMP compliance.

  • Maintains records in an orderly and easily retrievable manner

  • Oversees incoming AQL inspection on raw materials/finished goods/components according to written standard operating procedures, work instructions and specifications in Receiving.

  • Coordinates pulling and submitting a representative sample for at least identity and microbial testing.

  • Approves and releases incoming coming raw materials/finished goods/components.

  • Verifies and performs checks on cleaning processes as established in procedures pertaining to operation area before, during and after production.

  • Performs batch record review and approval as outlined to product specification.

  • Performs, monitors and documents 1st article inspection and in-process checks in batching, mixing and filling rooms in operation area.

  • Verifies calibration and verifications on equipment logs in operation area.

  • Responsible for pulling in-process and finished good samples for QC testing to verify purity, identity, specificity and conformance to product specification.

  • Responsible for performing AQL inspection on finished product.

  • Responsible for reviewing and releasing finished product for shipping.

  • Responsible for label control; process for received and released labels from Quarantine are followed.

  • Reports deviations, product, and in-process issues to Quality management.

  • Works with and supports Operation functions which involve Quality.

  • Complies with FDA, cGMP and other requirements and enforcing adherence to requirements.

Qualifications:

Job Qualifications

  • Three year's acceptable performance as Technician II or equivalent experience.

  • Knowledge and experience with applicable FDA regulation and cGMP requirements required.

  • High School Diploma or GED required.

  • Attention to detail and organization of tasks and workloads.

  • Excellent communication skills in writing, listening, and responding with feedback.

  • Strong organizational abilities.

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Application Instructions

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