Data Management Associate - Co-Op

Job Description

12 Month Co-Op Opportunity for an ELIGIBLE student in a Co-Op program – must maintain Co-Op eligibility until end of the Co-Op work assignment.

Summary:

Provide supports for Lab Operations (LO) activities such as SuccessFactors, Training records, Analytical Release Forms (ARF’s), Specification, Certificates of Analysis (CofA), Data Package Preparations, Compendial updates Elemental Impurities and Residual Solvents assessments.

Essential Functions: 

Training Record Management

• Support and maintain training records for Lab Operations
• Manage SuccessFactors Learning Management System (SFLMS) activities for Lab Operations
• Act as the Department lead and troubleshoots for SFLMS issues and provides support to end users
• Ensure Lab Operations aligns with SFLMS requirements
• Provide ongoing training and expertise to department users
• Develop Work Instruction (WI) related to Standard Operating Procedures (SOPs) or SFLMS as needed.
• Transfer the content SOP/WI to new Documentum template.
• Process SOP/WI to Documentum workflow.

ARF/Specification/CofAs/Compendial Updates, Elemental and Residual Solvent risk assessment Management

• Generate ARF/CoA based on Quality Record (QR)/Change Control requirements or new parts requests to meet MPS (Manufacturing Production Schedule) and On Time Delivery (OTD) of QRs
• Generate and revise Specifications/eCoAs per SharePoint requests
• Address client comments regarding ARFs/CoAs
• Review, update and maintain ARF index database
• Support Annual product review (APR) (as needed)
• Support indexing, filing and archival of obsoleted Artworks
• Support Gvault activities
• Support Compendial updates
• Support SampleManager activities

Data Package Management

• Prepare and create data package per Lab Operations requests by collecting data and information
• Work with lab and reviewer groups to addresses data package related client comments
• Maintain a safe working environment and report potential hazards.
• Perform alternating or rotating shift work (as required)

REQUIRED QUALIFICATIONS

Education:

High school diploma/General Educational Development (GED) Certificate is required

Working towards a College Diploma or University Degree in a Science related field.

Current enrollment in B.Sc. would be an asset

Experience:

Requires no previous related experience.

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills and Abilities:

Computer proficiency with Microsoft Office programs (e.g., Outlook, Excel, Word). Excellent interpersonal skills (verbal and written). Ability to multi-task. Detail Oriented and reliable. Works well independently and in a team environment. Proficiency with the English language.

Standards and Expectations:  

Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality systems SOP's and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion.  Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner.  Consistently strives to improve skills and knowledge in related field.    

Physical Requirements:

Light physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area.  There may be regular exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasionally.

Disclaimer: 

This job description is intended to present the general content and requirements for the performance of this job.  The description is not to be construed as a comprehensive statement of work, responsibilities, or requirements.  Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully align with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.