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Job Title:

Clinical Label Control Coordinator

Department/Group:

Clinical Ops

Location:

Assembly

Reports to:

Labeling Control Manager

FLSA Status:

Non-Exempt

Summary of Objective:

Direct point of contact for customers and vendors relating to clinical labeling to effectively communicate technical requirements for packaging purposes by understanding equipment functions, component designs, material structure, code and coding areas, and barcode data structures.

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.

Demonstrate facilitation of various component label copy revisions and successful management of customer art and vendor print proof files by understanding different processes defined by customer and vendor requirements. Independent decisions to complete technical approval reviews including component drawings and vendor die lines, customer artwork, and vendor print proofs to ensure component design, barcode, and coding areas align with PCI packaging process as well as performing barcode scans and verifying barcode type, encoded data, density or cell size, and structure are accurate. Design labels to print internally (PCI Label Room); label copy and barcode data structures created per GS1 (Global Standards) and customer logistics, distribution center requirements that include standards for track and trace (serialization), HDMA (Healthcare Distribution Management Association), and HIBCC/UDI (Healthcare Industry Business Communications Council/Unique Device Identification). Direct point of contact to process internal drawings and vendor die lines through customer approvals. Proofreading accuracy and ability to multi-task in a fast paced environment. Manage clinical randomization files including creation and comparison inspections. Schedule and host conference calls, meetings with customer and vendor representatives, as needed. . Participate in Clinical trial operation planning meetings as required, interact with project manager, QC/QA, production, planning, validation and warehouse to ensure that jobs are completed in a timely manner minimizing delays to production. Assisting in the hosting of external and internal audits of the Labeling Department Complete component specification, LE form, and batch record reviews within SmartProd-Pilgrim. Conduct efficient and accurate departmental handover meetings prioritizing workload in line with production scheduling Assist in the training of others to use the label printing systems. Work in a safe manner at all times and highlight any safety issues to the appropriate person as soon as possible. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. This position may require overtime and/or weekend work. 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: 3/4 of the day and up.
• Move, Traverse: Up to 1/4 of the day.
• Operate, activate, use, prepare, inspect, or place: 3/4 of the day and up.
• Install, place, adjust, apply, measure, use, or signal: From 1/4 to 1/2 of the day.
• Ascend/Descend or Work Atop: Up to 1/4 of the day.
• Position self (to) or Move (about or to): From 1/4 to 1/2 of the day.
• 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

less than 1/4 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 is primarily performed at a desk and/or in an office environment. for 3/4 of the day and up.
• The noise level in the work environment is typically, very quiet.

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:

• High School Diploma or GED and/or 3-5 years related experience and/or training.

• Basic Mathematical Skills
• Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.

Preferred

• Ability to effectively present information to various people as the job requires.
• Ability to display a willingness to make decisions.
• Ability to work independently and/or as part of a team.
• Ability to exhibit sound and accurage judgment.
• Ability to demonstrate attention to detail.
• Ability to identify and resolve problems in a timely manner.

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