Inspection & Packaging Supervisor (1:30 pm-10 pm)

American Regent, Inc.•New Albany, OH

15h

About The Position

The Inspection & Packaging Supervisor is a member of the Manufacturing Team, which manufactures safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies, and cGMPs. The role oversees inspection, labeling, packaging, and cartoning, as well as cleaning, assembling, and collecting QC samples to manufacture sterile liquid and lyophilized pharmaceuticals according to established production records. The position oversees automated inspection, labeling, and packaging systems, manual glass-vial inspection, equipment teardown, and line clearances. The supervisor is responsible for the proper operation of inspection, labeling, and packaging equipment and for keeping processes compliant and inspection-ready. The role includes signatory approval of process activities, proper use of batch documentation, troubleshooting processes and equipment, making adjustments and minor repairs when needed, and contributing to Inspection and Packaging Batch Records. The supervisor also provides direction, training, and mentorship to Inspection and Packaging staff.

Requirements

High school diploma or G.E.D.
Experience with cGMP guidelines and FDA regulations.
Experience with HMI-PLC/SCADA control data systems in a relevant field.
1–3 years of experience in a leadership role in the Inspection/Packing area.
Good oral and written English communication and comprehension skills.
Ability to perform basic mathematical calculations.
Ability to take feedback constructively and function in a team-oriented work environment.
Ability to work overtime as needed.
Physical ability to wear laboratory protective gowning and equipment, including gowns, goggles, face shields, respirators, and protective gloves.
Ability to occasionally lift and/or move up to 50 pounds.

Nice To Haves

Bachelor’s degree in Pharmaceutical Science, Chemistry, (Micro) Biology, Engineering, or a related field.
Experience with fully automated inspection and packaging systems.

Responsibilities

Maintain equipment and supply inventories and ensure they are available in accordance with production schedules.
Ensure only approved materials, equipment, documentation, and procedures are used.
Ensure personnel perform only tasks for which they have accurate and approved training records.
Coordinate scheduling with the Filling Department to ensure timely processing of products.
Analyze department performance and implement strategies to improve employee safety, product quality, and productivity.
Identify and address individual and team training and development needs.
Staff Inspection and Packaging operating stations to support the production schedule.
Ensure proper QC sampling techniques and procedures are used and deliver samples to the QC laboratory on time.
Analyze staffing needs and make appropriate staffing adjustments.
Assure GMP-compliant operations by the Inspection and Packaging Team.
Attend training programs required by company SOPs, procedures, and policies.
Develop operational tactics for manufacturing startup activities.
Prepare for Pre-Approval Inspection and prepare for and participate in regulatory audits.
Ensure workplace safety and security across manufacturing areas in accordance with OSHA, EPA, DEA, and other applicable standards.
Interview, hire, and train employees; plan, assign, and direct work; appraise performance; reward and discipline employees; address complaints; and resolve problems.
Oversee and provide signatory approval for Inspection and Packaging process activities.
Troubleshoot manufacturing processes and equipment and make adjustments or minor repairs during setup and operations as necessary.
Provide input and assistance in creating Inspection and Packaging Batch Records.