Origin: a Latin derivative
meaning "Gift of the Earth."
Job Description: Materials and product inspections and releases; document reviews and approval, pulling of samples, reporting of nonconformance, monitoring of GMP compliance.
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.
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.