Quality Control Inspector

Description:

The Quality Control Inspector is responsible for assuring that activities, processes, and specific conditions related to the daily manufacturing, processing, packing, and holding of active pharmaceutical ingredient (API), drug product, and medical devices meet current Good Manufacturing Practices and comply with applicable procedures and standards such as to ensure the quality integrity of the products. The Quality Control Inspector engages in functional and analytical assessments to ensure quality is built into the products manufactured in manufacturing facilities. These activities support the goal of reliably and demonstrably providing safe and efficacious products to our patients and customers with the assurance that such is conducted in compliance with applicable government regulations and guidelines as well as with company policies and procedures.

Essential Functions:

If the starting position is in the incoming laboratory and in-process inspections:

Performs area clearances/line clearances, in-process inspections of manufacturing processes, and inspection and disposition of incoming material.

Monitors manufacturing process performance as relates to SPC/SQC, general compliance status of manufacturing and warehouse areas, as well as ensures components, products, or equipment under evaluation or not in compliance are properly controlled.

Prepares and attaches material quality status on materials, including labeling.

Performs the verification of all labels after final printing is completed.

Supports the quality audit function through occasional conduct of investigations of non-conformances or deviations and assists with corrective actions and preventive actions associated with site quality.

OR

If the starting position is in analytical laboratories:

Performs chemical analysis of raw material, in-process materials, finished drug product, stability, validation, and R&D samples in accordance with OSHA, EPA, FDA, cGMP, and other appropriate regulatory requirements within the Quality Control Laboratory.

Performs the collection, handling, and documentation of raw materials, chemical reagents, laboratory standards, and sample vessels (handles and moves compressed gas cylinders).

Performs the calibration and preventative maintenance of analytical instruments.

Education / Experience / Skills:

An associate’s Degree in a technical or scientific field is required. Bachelor’s Degree preferred.

Experience in a regulated work environment is preferred

Quality certificate preferred (ASQ CQE, CQA, etc.)

Understand and internalize drug cGMPs, OSHA, EPA, and FDA regulations/requirements as related to drug and medical device manufacturing.

Basic knowledge of laboratory analyzers and inspection equipment used to perform chemical analyses and component inspections.