Quality Control Coordinator

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI. 

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Job Title: Quality Control Coordinator

Department/Group: Quality Operations

Location: Assembly

Shift: 1ST SHIFT

Summary of Objective:

The Quality Assurance Coordinator is responsible for properly maintaining critical Quality Assurance Inspection systems including the PCI Non-Conforming Material Report (NMR) system and the PCI retain / customer sample programs.  These systems are to be maintained in accordance with PCI, Customer and GMP requirements.

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.

Properly pack for shipment daily customer samples including cold chain Review customer standards, procedures and specifications relative to customer sample and retain requirements. Responsible for organizing and maintaining proper storage and disposal of PCI and customer retain samples. Maintain adequate inventory of cold shipment supplies. Perform annual visual inspection of retains per APR requirements. Organize and maintain NMR associated paperwork including samples and ensuring proper close out. Maintain accurate logs of all NMR’s. Perform all NMR associated transactions within JDE. Coordinate with appropriate Business Unit representatives, Purchasing, Warehouse and Quality on NMR details and disposition. Maintain required Quality Metrics related to NMR’s and report to Management on a routine basis. 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: From 1/2 to 3/4 of the day.
• Move, Traverse: From 1/2 to 3/4 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: From 1/2 to 3/4 of the day.
• 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

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 performed in areas with moderate risk or discomfort that may require special safety precautions, such as wearing protective clothing or gear for 1/2 to 3/4 of the day.
• Work is primarily performed at a desk and/or in an office environment. for 1/4 to 1/2 of the day.
• Work near moving mechanical parts for up to 1/4 of the day.
• Work in high, precarious places for 1/4 to 1/2 of the day.

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 at approved gr