Sr. Packaging Specialist

Sr. Packaging Specialist

The Sr. Packaging Specialist must be able to work in a team environment to offer quality packaging and labeling of customer's clinical trials. This position is expected to lead production rooms and ensure quality product is outputted from production batch records. Additionally, this role will have responsibilities for label control and training of new staff. 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 product and capsule manufacturing. These individuals must be detail oriented in order to work with multiple look-alike products at the same time.

Roles and Responsibilities:

• Lead production rooms and runs from pre-line, execution, to post-line activities
• Perform production EBR review
• Responsibilities for label control including label printing, creation of master blinding forms, and initial/final inspection of labels
• Fastchain Productions and Management of 3-day Turnaround Time
• JDE SME for production activities
• Responsible and perform OJT for production team members
• Shared responsibilities with the Production Manager on maintaining the production schedule and management of staff in rooms on a day-to-day basis
• May be responsible for assisting investigations related to any deviations or customer complaints from the result of operational processes
• Inspect blister cavities for missing products, burnt product, holes in foil, print registration, missing print, crushed blisters and seal integrity.
• Fill tablet, bottle, desiccant and closure hoppers. Hand count product using counting trays.
• Manufacturing responsibilities include de-inking product, tablet breaking, product placement into oversized capsules and capsule inspection.
• Inspect bottles for misalign closures, print registration and missing print copy.
• Inspect seal integrity of pouch, print registration and missing print copy.
• Inspect blister units and place them into properly assigned card locations for multi-fill operations.
• Responsible for cleaning machine equipment and production rooms as stated in cleaning SOP's.
• Fill in all appropriate information in the cleaning logbooks.
• Responsible for cleaning product contact parts.
• When working on look-alike products you are only allowed to work with your assigned product. Multi-fill projects require that employees do not touch or help other employees that are assigned different products.
• Responsible for cleaning production rooms with three bucket sponge mop cleaning system which includes ceilings, walls and floors.
• All clinical labels must be inspected and require 100% accountability. Clinical labels can be either manually or automatically applied.
• Sealed clinical cards must be inspected for missing copy, poor seal, smudges and dirt, misalign blister units and burnt product.
• Inspection required for vials, ampoules and syringes utilizing black and white light boxes.
• Cold storage packaging will also be required working with cold products, both outside and inside refrigeration conditions.
• Assembly work required, which may include utilizing barcode scanning equipment and computers.
• Other duties as assigned.

Must Have: Education or Experience:

• Bachelor's degree preferred.
• Minimum of 6 years of relevant industry experience in a cGMP environment, or comparable pharmaceutical or clinical knowledge and experience.
• Minimum of 4 years of operating and maintaining packaging equipment (blistering, bottling, carding) or relevant packaging equipment experience.