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

Nature and Scope

This position is a member of the Manufacturing Team, responsible for activities associated with the manufacture of safe, effective and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs. The Supervisor – Inspection / Packaging will participate in all aspects of the Inspection / Packaging Process, including inspection, labeling, packaging and cartoning, cleaning, assembling and collecting QC samples in accordance with established production records.

The manufacturing technology utilized in New Albany includes HMI-PLC/SCADA controlled Inspection, Labeling, and Packaging equipment. The Supervisor will oversee and provide signatory approval of all activities associated with the Inspection / Packaging process, provide direction, training and mentorship to Inspection and Packaging Staff, and be responsible for the proper operation of equipment and use of batch documentation.

Essential Duties and Responsibilities

• Ensures equipment and supply inventories are maintained and available for use in accordance with production schedules.
• Ensures only approved materials and equipment are utilized at all times.
• Ensures that personnel do not perform tasks for which they do not have accurate and approved training records.
• Ensures that only approved documentation and procedures are utilized at all times.
• Coordinates scheduling activities with Filling Department to ensure timely processing of all products.
• Analyze department performance and proactively identify and implement strategies to improve employee safety, product quality and productivity.
• Identify and address individual/team training and development needs.
• Staffs Inspection and Packaging operating stations in support of production schedule.
• Ensures proper QC sampling techniques and procedures are utilized and ensures timely delivery of samples to the QC laboratory.
• Analyze staffing needs and make appropriate staffing adjustments.
• Assure GMP compliant operations are being performed by the Inspection / Packaging Team.
• Attends all training programs as required by Company SOPs, procedures and policies.
• Develop operational tactics for manufacturing start up activities.
• Prepare for Pre-Approval Inspection.
• Prepare for and participate in regulatory audits.
• Ensure workplace safety and security within OSHA, EPA, DEA and all applicable governing body standards across manufacturing areas.
• Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Education Requirements and Qualifications

• High School Diploma or G.E.D. required.
• Bachelors' Degree in Pharmaceutical Science, Chemistry, [Micro] Biology, Engineering or a related field preferred.
• Experience with cGMP guidelines and FDA regulations required.
• Experience with HMI-PLC/SCADA control data system in a relevant field required.
• 1-3 years of experience in a leadership role in the Inspection/Packing area required.
• Experience in fully automated inspection and packaging systems preferred.
• Possesses 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 Environment and Requirements

Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. Employee must be able to occasionally lift and/or move up to 50 pounds.