Quality Control Inspector

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job 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 (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.

Essential Functions

• 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.

Minimum Requirements

Education / Experience / Skills:

• Associate's Degree in technical or scientific related field required

• Bachelor's Degree (preferably in a science related field) preferred

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

• At least 2 years of experience in a FDA regulated work environment is preferred

Competencies:

• 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.

Organizational Relationship/Scope

This position reports locally to the Quality Control Supervisor.

This position directly supports Manufacturing, Materials Management, and Quality Assurance functions.

Working Conditions

Majority of work will be in manufacturing environment, with some work performed in an office setting. Will be required to sit or stand for long periods of time, work with chemical reagents and compressed gas cylinders, and lift, push, or pull up to 50lbs.

Use of personal protective equipment (PPE), including but not limited to safety glasses, apron, face shield, and steel toed shoes will be required.

Keenova offers employees a Total Rewards package which includes competitive pay and benefits.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.