Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

Summary:  

Provide support for Lab Operations (LO) Organization activities. 

 

Essential Functions:   

Document Management 

Scan, electronically store, photocopy, distribute, file and archive LO documents as needed. 

Manage document storage at off-site location 

Support drafting effective Good Manufacturing Practices (GMP) documents 

Create and manage Notebooks and Logbooks 

Scan Laboratory Notebooks and Logbooks and maintain database 

Assign Document Control Numbers and CTMLP Numbers 

Type testing results into CoA as requested  

Distribute Internal/External Mail for Laboratory Operations 

ARF’s, PDCSs, PDTF’s,  Artwork, Management  

Support the Analytical Release Form (ARF’s) activities such as scanning, obsoleting, making effective, removal of superseded ARF’s and index update. 

Support Annual product review (APR) by gathering relevant documentation 

Support tracking logs such as list of all ARf’s, metrix creations, etc. 

Support indexing, filing and archival of obsoleted Artworks/Acetate 

Manage Packaging Development Component Specifications (PDCSs) (scanning, making effective, supseding, obsoleting, index update) 

Manage Packaging Development Test forms (PCTFs) (scanning, making effective, supseceeding, obsoleting, index update) 

Manages testing methods 

Maintain a safe working environment and reports potential hazards.  

 

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. 

 

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). Good interpersonal skills (verbal and written). Ability to multi-task. Detail oriented with a focus on accuracy.  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 Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion.  Actively engage in and adhere to departmental systems 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.