Clinical Line Leader 1

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The Clinical Line Leader (I, II, or III) role is a leadership position within the clinical operations department responsible for leading assigned packaging lines, rooms, and crews.  The Clinical Line Leader is the subject matter expert for their assigned batch record, and owns the completion of the packaging activity at the highest level of quality, including a “Right First Time” batch record.  The Clinical Line Leader position is critical to the successful execution of packaging campaigns.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

Prepares the line for production by receiving updates from the previous shift; gathering daily paperwork; reviewing work order jackets; performing system challenges and checks as required by the batch records; verifying equipment calibration expiration dates; ensuring product meets quality standards; and completing necessary documentation correctly and completely. Provides direction to Clinical Packer Technicians by ensuring the crew has executed and documented the appropriate activities as called out in the batch record, assigning crew members to the appropriate positions; ensuring Clinical Packer Technicians are trained and understand the batch record, randomization list and are prepared with the skills to perform job functions; and assisting Clinical Packer Technicians with questions or issues. Can lead multiple clinical production lines at the same time, with various types of work order activity. Works in a zero defect environment, ensuring each and every package meets clinical standards of precision and perfection. Manages the individual randomization lists in each work order to assure that all blinding activities within the work order comply with the randomization list. Performs and leads team to package and inspect quality into the product, as machines and technology are not utilized on every line. Can make judgment calls on package assembly and conform to standards required by the study blinding required in the work order. Ensures work is consistent between work orders to maintain clinical blinding requirements. Proposes creative solutions to problems and resolve issues for the working requiring zero defects. Works effectively in a clinical packaging environment that utilizes serialized kit numbers, when packaging lot is made up of multiple individual packaging lots. Work with frozen and refrigerated products, must be able to handle these products with any required procedures and gowning as directed by the product handling. Work with distribution team and Clinical Packer Technicians to facilitate the determination of best pack out for clinical distribution activities when not called out specifically in the batch record documentation. This includes making decisions on appropriate shipper box, partitions, dunnage, as well as how to sequence the kits into the proper order to ensure ease and accuracy of picking. Complete and manage ship case identification with clinical sequential and unique kit ID tags. Determine and follow pattern for storage on appropriate pallet, cage, cart or other. Performs Return to Stock activities on the line, with 100% accountability on bulk and labels typically required for all labeling jobs. Ensures practices within the work center ensures no potential issues with accountability issues or mixed up components. Keeps Supervisors aware of important information by communicating potential disciplinary issues, machine malfunctions, and quality issues. Completes necessary documentation by gathering and calculating scrap, recovery and production rates; completing batch record entries; ensuring that daily production reports are accurate and complete; and completing continuous improvement documentation. Leads and performs lot out by labeling and removing components; performing line clearances; determine component utilization for next work order; cleaning, sanitizing and inspecting the line area; and obtaining final quality inspection for line clearance. Performs mass completions as needed. Leads and performs lot in by obtaining work order jackets; communicating with necessary departments (e.g. Warehouse, Maintenance, Quality; setting up line according to line layout; performing system checks and challenges as required by the batch records; ensuring product meets quality standards; and obtaining Supervisory approval to begin production. Performs basic troubleshooting by notifying Maintenance