Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Summary:

Responsible for receiving, filing, controlling, and retrieving of executed GMP documents such as batch records and validation reports, including off-site storage. Maintains the controlled document library (archives), which includes routine filing. Manages the process for the disposition of GMP documents, including shipment of documents to Clients or destruction of Client and Site documents. Supports Compliance Auditors in audit preparations including document retrieval and assembly. Compliance projects as required.

Essential Functions:

Accurately maintain document database and archives.
Retrieve documents in a timely manner.
Enforce procedures governing document management and compliance requirements including records retention policies. Must collaborate cross-functionally to reinforce site requirements.
Responsible for maintaining access to the controlled Document Library including the removal and return of records stored within. Includes offsite storage of documents.
Support onsite Customer and Regulatory audits.
Receive, file, and retrieve documents.
Manage process for disposition of GMP documents that have reached their retention periods, including shipment of documents to Clients or destruction of Client and Site documents.
Prepare documentation for offsite storage.
Secure required documentation on time to maintain client deadlines. Work with other departments to locate documents.
Respond to regulatory, customer or internal requests for document information and to general questions pertaining to document control.
Facilitate periodic review (reconciliation) of controlled documents in accordance with site procedure.
Maintain a safe working environment and report potential hazards.

REQUIRED QUALIFICATIONS

Education:

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

Experience:

Requires no previous experience.

Equivalency:

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

Knowledge, Skills, and Abilities:

Organized and detail-oriented. Demonstrated computer proficiency in Microsoft Office products (Word, Excel, PowerPoint). Ability to work on multiple projects simultaneously. Exceptional communication and interpersonal skills. Proficiency with the English Language.

Standards and Expectations:

Follow all Environmental Health \& Safety Policies and Procedures. Work collaboratively with fellow team members, modeling 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 engaging in problem-solving. Model positive thinking and be 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 strive to improve skills and knowledge in the related field.

Physical Requirements:

Moderate physical effort and fatigue. Walks, sits, or stands for limited periods. May require recurring stretching or reaching. Regular movement of files, binders, and boxes of documentation to and from off-site storage. Climbing of ladders to reach upper shelves. 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 occasion.

Thermo Fisher Scientific

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