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Summary of Objective:

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. PAPR Certification is required as many products require PAPR use. 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 and Supervisors of mechanical issues; taking product samples; performing and diagnosing quality checks and tests; observing and monitoring the CDC: performing basic adjustments; and complying with quality-alert instructions. Leads Clinical Packer Technicians by operating a variety of packaging machinery; assisting in the set-up/changeover of packaging machinery or equipment by using layout schematic; leading rework efforts; and interpreting statistical process control charts. This position may require overtime and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Attendance to work is an essential function of this position Performs other duties as assigned by Manager/Supervisor.

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions

• Stationary Position: None
• Move, Traverse: 3/4 of the day and up.
• Operate, activate, use, prepare, inspect, or place: 3/4 of the day and up.
• Install, place, adjust, apply, measure, use, or signal: 3/4 of the day and up.
• Ascend/Descend or Work Atop: 3/4 of the day and up.
• Position self (to) or Move (about or to): 3/4 of the day and up.
• Communicate or exchange information: 3/4 of the day and up.
• Detect, distinguish, or determine: 3/4 of the day and up.

On an average day, the individual can expect to move and/or transport up to 25 pounds

between 1/2 and 3/4 of the day.

This position may have the following special vision requirements.

• Close Vision Distance Vision Color Vision Peripheral Vision Depth Perception
• Ability to focus No Special Vision Requirements

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.

• Work near moving mechanical parts for 3/4 of the day and up.

The noise level in the work environment is typically, moderate.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• Skills testing requirements met at approved grade level for position.
• Basic Mathematical Skills
• Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs.
• Limited Working Proficiency: The ability to satisfy routine social demands and limited work requirements. The ability to read simple prose, in a form equivalent to typescript or printing, on subjects within a familar context.
• Basic Reasoning: Ability to apply common sense understanding to carry out uninvolved written or oral instructions. Ability to deal with problems that involve only a few concrete variables in standardize situations.

Preferred:

• Ability to follow instructions and respond to management direction.
• Ability to identify and resolve problems in a timely manner.
• Ability to work independently and/or as part of a team.
• Ability to show success in managing employees.

• High School Diploma or GED and/or 1-3 months related experience and/or training.

Join us and be part of building the bridge between life changing therapies and patients.

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.