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

American Regent•New Albany, OH

16h

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 team maintains aseptic and sanitary conditions where required, accurate manufacturing-area and equipment records, and safe, professional conduct while helping meet production schedules and company goals. The supervisor participates in and oversees inspection and packaging activities for sterile liquid and lyophilized pharmaceuticals. These activities include inspection, labeling, packaging, cartoning, cleaning, assembly, QC sample collection, equipment teardown, and line clearances. The process uses fully automated inspection, labeling, and packaging equipment as well as manual vial inspection. Manufacturing equipment in New Albany uses HMI-PLC/SCADA controls. The supervisor approves activities associated with the process, directs and mentors staff, and is responsible for proper equipment operation, compliant and inspection-ready processes, and correct use of batch documentation. The role also troubleshoots processes and equipment, makes adjustments and minor repairs when needed, and contributes to the creation of Inspection and Packaging Batch Records.

Requirements

High school diploma or GED.
Experience with cGMP guidelines and FDA regulations.
Experience with HMI-PLC/SCADA control data systems in a relevant field.
1–3 years of leadership experience in the Inspection/Packaging area.
Good oral and written English communication and comprehension skills.
Ability to perform basic mathematical calculations.
Ability to accept feedback constructively and work in a team-oriented environment.
Ability to work overtime as needed.
Ability to wear laboratory protective gowning and equipment, including 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 in accordance with production schedules.
Ensure only approved materials, equipment, documentation, and procedures are used.
Verify that personnel perform only tasks for which they have accurate, approved training records.
Coordinate schedules with the Filling Department to ensure timely product processing.
Analyze department performance and identify 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 samples are delivered to the QC laboratory on time.
Analyze staffing needs and make appropriate staffing adjustments.
Ensure 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 participate in regulatory audits.
Ensure workplace safety and security meet OSHA, EPA, DEA, and other applicable governing-body standards across manufacturing areas.
Interview, hire, train, plan and assign work for, and direct employees; appraise performance; reward and discipline employees; and address complaints and resolve problems.
Oversee and approve activities associated with the Inspection and Packaging process.
Direct, train, and mentor Inspection and Packaging staff as needed.
Ensure proper operation of inspection, labeling, and packaging equipment and keep processes compliant and inspection-ready.
Ensure proper use of batch documentation.
Troubleshoot manufacturing processes and equipment and make adjustments and minor repairs during setup and operations when necessary.
Provide input and assistance in creating Inspection and Packaging Batch Records.