Quality Control Inspector

Mallinckrodt Pharmaceuticals•Port Allen, LA

37d

About The Position

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 (cGMPs) 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 at the Port Allen, LA 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.

Requirements

Associate's Degree in technical or scientific related field required
At least 2 years of experience in a FDA regulated work environment is preferred
Understand and internalize drug cGMPs, OSHA, EPA, and FDA regulations/requirements as related to drug and medical device manufacturing.
Proficient in Word and Excel.
Mathematical skills
Mechanical aptitude
Excellent oral and written communication skills; interpersonal skills; and organizational skills.
Detailed-oriented.
Excellent team ethic and practice.
Collaborative, tactful, and able to communicate with various levels in the organization.
Assertive in enforcing regulations, policies, and procedures.
Basic knowledge of laboratory analyzers and inspection equipment used to perform chemical analyses and component inspections.

Nice To Haves

Bachelor's Degree (preferably in a science related field) preferred
Quality certificate preferred (ASQ CQE, CQA, etc.)

Responsibilities

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, product or equipment under evaluation or not in compliance is properly controlled.
Prepares and attaches material quality status on materials, including labeling.
Performs the verification of all labels after final printing is completed.
Executes assigned activities in accordance with production schedule and participates in production schedule planning, as needed.
Assists in the development, implementation, and maintenance of site quality procedures, standards, and controls.
Performs other tasks related to the assurance that product meets established standards for quality and efficacy as assigned by supervisor.
Assist in special projects and cross functional teams as assigned by supervisor to meet company and departmental goals.