Documentation Coordinator

4 weeks ago

Mississauga, Canada PCI Pharma Services Full time

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:
Document Coordinator

Locations:
Mississauga

Business Type:
Commercial

Department/Function:
Production - Ops

Reports to:
Director of Operations

Exempt

Exempt

Prepared By:
Jamie Heisz

Approved By:
Olivia Burgess

Summary of Objective:
Performs all duties related to the compiling of appropriate documents, issuing of Production Batch Records, printing labels, and coordination between departments in order to provide a fully issued Production Batch Record. Creates production orders in the Optel Site Master for packaging to execute.

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.

Proactively evaluates availability of drug & components to meet production schedule. Works with Buyer and/or Account Reps to ensure availability of components for production. Copies Master PBR's for issuance. Creates Production Orders in Tropos & issues Pick Lists to the warehouse. Troubleshoots and communicates clearly to the appropriate departments when any production delays are identified as a result of missing/unreleased components. May assist the production team with batch closures and Tropos transactions as required. Develop master shipping case labels using Label View / Bartender Software. Prints shipping case labels for production orders according to customer specifications. Receives Shipping Cases labels into Tropos. Maintains master shipping case label specifications Records and maintains documentation as per QA and other audit requirements. Maintains label and ribbon stock. Follows up with Project Managers on customer releases for drug / components. Creates production orders in the Open Site Master for serialized products. Works on projects and other duties as assigned. 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: 3/4 of the day and up.
- Move, Traverse: From 1/4 to 1/2 of the day.
- Operate, activate, use, prepare, inspect, or place: Up to 1/4 of the day.
- Install, place, adjust, apply, measure, use, or signal: Up to 1/4 of the day.
- Ascend/Descend or Work Atop: Up to 1/4 of the day.
- Position self (to) or Move (about or to): Up to 1/4 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 10 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

MENTAL EFFORT REQUIRED TO PERFORM THE JOB

Concentration and visual discernment during the scrutinizing and proofing of work.Attention to detail when entering data.Mental attentiveness and professionalism when providing commentary or coordinating people and tasks.

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.
- Work is performed in areas with moderate risk or discomfort that may require special safety precautions, such as wearing protective clothing or gear for up to 1/4 of the day.

The noise level in the work environment is typically, 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:

- 1 to 3 years’ experience in manufacturing, preferably in

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