Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Summary:

Provide support for Lab Operations (LO) Organization activities.

Essential Functions:

Document Management

• Scan, electronically store, photocopy, distribute, file and archive Laboratory Operations (LO) documents as needed.

• Manage document storage at off-site location

• Support in drafting effective Good Manufacturing Practices (GMP) documents

• Create and manage Notebooks and Logbooks

• Scan Lab Notebooks and Logbooks and maintains database

• Assign Document ControlNumbersand CTMLP Numbers

• Type testing results into CoA as requested

• Distribute Internal/External Mails for Laboratory Operations

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

• Support the Analytical ReleaseForm (ARF’s) activities such as scanning, obsoleting, making effective, removal of superseded ARF’s and index update.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 Developement Component Specifications (PDCSs) (scanning, making effective, superseding, obsoleting, index update)

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

• Manage testing methods

• Maintain a safe working environment and report potential hazards.

• Perform alternating or rotating shift work (as required)

REQUIRED QUALIFICATIONS

Education:

College Diploma in Sciences or related field

Experience:

Previous experience in a science related environment

Minimum 1 year experience in the administrative function preferably in a pharmaceutical environment

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 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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.