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

Nature and Scope

This position is a member of the Manufacturing Team. The Manufacturing Team is responsible for activities associated with the manufacture of safe, effective and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs.

The Manufacturing Team ensures aseptic and sanitary conditions are maintained where required, that appropriate manufacturing area and equipment records are neat and accurate and that safe, effective and professional behavior is displayed at all times. In conjunction with Production Management the Manufacturing Team provides input and assistance to other Departments as needed, playing a critical role in maintaining production schedules and meeting Company goals. The Supervisor - Inspection / Packaging will be able to participate in all aspects of the Inspection / Packaging Process. The process includes inspection, labeling, packaging and cartoning along with cleaning, assembling and collecting QC samples in accordance with established production records in a concerted effort to manufacture sterile liquid and lyophilized pharmaceuticals.

The Inspection / Packaging Process includes fully automated inspection, labeling, and packaging, as well as manual inspection glass vials, and the tear-down and line clearances of the manufacturing equipment. The manufacturing technology utilized in New Albany includes HMI-PLC/SCADA controlled Inspection, Labeling, and Packaging equipment. The Supervisor - Inspection / Packaging will be able to oversee and provide signatory approval of all activities associated with the Inspection / Packaging process. The Supervisor - Inspection / Packaging will be able to provide direction, training and mentorship to all Inspection and Packaging Staff as needed.

The Supervisor - Inspection / Packaging will be the responsible person for the proper operation of the Inspection, Labeling, and Packaging equipment and ensure that all processes are in a compliant and inspection ready state. The Supervisor - Inspection / Packaging will be the responsible person for the proper use of batch documentation. The Supervisor - Inspection / Packaging will be able to troubleshoot most manufacturing processes and equipment and where necessary make adjustments and minor repairs during setup and during operations. The Supervisor - Inspection / Packaging provide input and assistance in creating Inspection and Packaging Batch Records.

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. [Bulleted list item]
• 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.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf

• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)

• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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