Senior Packaging Specialist

About the role

The Sr. Packaging Specialist for our Clinical Supply Services group will work in a team environment to offer quality packaging and labeling of customers’ clinical trials. This person will lead production rooms and ensure quality product output from production batch records. Additionally, this role will have responsibilities for label control and training of new staff.

Responsibilities

• Lead production room activities from pre-line setup through execution and post-line closeout, ensuring smooth daily operations.
• Maintain and manage the production schedule in partnership with the Production Manager, including staff coordination and room oversight.
• Serve as JDE subject matter expert (SME) for production-related system transactions and workflows.
• Conduct on-the-job training (OJT) for production team members and ensure adherence to SOPs and operational standards.
• Perform EBR reviews, support deviation or complaint investigations, and ensure accurate completion of required logbooks and documentation.
• Manage label control processes, including label printing, creation of master blinding forms, and initial/final label inspections with 100% accountability for clinical labels.
• Inspect sealed clinical cards, labels, and associated packaging components for print accuracy, seal integrity, and overall quality.
• Execute assembly operations utilizing barcode scanners and computer systems, including Fastchain production tasks with a 3-day turnaround requirement.
• Fill hoppers with tablets, bottles, desiccants, and closures; conduct hand-counting activities and perform specialized manufacturing tasks such as de-inking, tablet breaking, and capsule oversizing.
• Clean production rooms, equipment, and product-contact parts per SOPs, including three bucket mop procedures, while maintaining strict segregation protocols for lookalike and multi fill products.

Requirements

• A High School Diploma/GED or equivalent required.
• A Bachelor’s degree preferred.
• Minimum of six (6) years of relevant industry experience in a cGMP environment, or comparable pharmaceutical or clinical knowledge and experience.
• Minimum of four (4) years of operating and maintaining packaging equipment (blistering, bottling, carding) or relevant packaging equipment experience.
• Basic knowledge is required in Microsoft Office software and query-based systems activities as well as electronic batch record (EBR) software.
• Must be able to follow written and oral instructions in an accurate manner and problem-solve using analytical skills.
• Must be able to work overtime as required.

Qualifications

• Able to perform duties which include standing, walking, sitting, kneeling, push/pulling frequently and significant amount of use of office equipment.
• Able to lift up to 35lbs and work in temperature-controlled freezers/fridges frequently.

Skills

• Microsoft Office software proficiency.
• Query-based systems activities.
• Electronic batch record (EBR) software.

Benefits

Employees will be involved with handling look-alike products and labeling. Clinical operations can be run as a blister fill, bottle fill, pouch, carding, vial/syringe inspection or hand assembly. Employees will also be involved with de-inking of products and capsule manufacturing.

Pay

The anticipated salary range for this role in San Diego, CA is $55,000 to $65,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.