Quality Control Inspector

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

The Quality Control Inspector, for incoming laboratory and in-process inspections, 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.

This position also engages in functional and analytical assessments to ensure quality is built into the products manufactured at the Port Allen, LA manufacturing facility. 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.

• Supports the quality audit function through occasional conduct of investigations of nonconformances or deviations and assists with corrective actions and preventative actions associated with site quality.

• Performs other tasks related to the assurance that product meets established standards for quality and efficacy as assigned by supervisor.

• Performs special projects as assigned by supervisor to meet company and departmental goals.

Minimum Requirements

Education / Experience / Skills:

• Associate's degree in a technical or scientific field required.

• Quality certification preferred (e.g., ASQ CQE, CQA).

• Knowledge of drug cGMPs, OSHA, EPA, and FDA regulations.

• Strong mechanical aptitude and familiarity with laboratory analyzers and inspection equipment.

• Excellent teamwork and communication skills.

• Collaborative and tactful in interacting with all organizational levels.

• Assertive in enforcing regulations, policies, and procedures.

Preferred Skills:

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

• Experience in a regulated work environment

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. To learn more about our Total Rewards benefits please visit: Keenova Careers | Serve and Grow with Purpose | Keenova

This position is eligible for a bonus in accordance with the terms of the applicable program. Bonuses are awarded at the Company's discretion.

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.

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At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support-showing up in big moments and small to help patients find comfort and confidence.

We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology,men's health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.

We are Keenova-keen to solve, keen to serve. Learn more atwww.keenova.com.