Technical Writer Operations Specialist

4 weeks ago

Whitby, Canada Thermo Fisher Scientific Full time
Job Summary:

We are seeking a skilled Technical Writer to join our Operations team at Thermo Fisher Scientific. As a Technical Writer, you will be responsible for preparing and revising Standard Operating Procedures (SOPs) based on Deviation Reports (DR) and Corrective Action Preventative Action (CAPA) initiatives. You will also assist Production Management groups through completion of administrative tasks as assigned.

Key Responsibilities:

Review, revise, and prepare procedures/SOPs for compliance to Good Manufacturing Practices (GMP) and to reflect current work activities in Operations department
Ensure procedures/SOPs for Operations department are of sufficient detail for technical content, accuracy, clarity, completeness, and flow
Ensure procedures/SOPs are regularly reviewed and kept up to date with proper approvals
Work closely with Compliance Department to ensure SOPs are reviewed and revised appropriately and training is provided
Work closely with Technical Operations, PPT Engineers, and processing and packaging departments in the generation and approvals of SOPs and CCs
Track status of in-process SOPs, training, and other activities
Create change controls

Department Contributions:

Work with Operations Personnel to identify process improvements
Attend key project meetings, client teleconferences, and on-site visits
Support production department with logbook system, retrieval, and management for audits and storage purposes
Act as a back-up to any department coordinators
Perform alternating or rotating shift work (as required)
Maintain a safe working environment and report potential hazards
Maintain a personal project list of assignments with target completion dates

Metrics:

Collect and analyze Operations Administration metrics and identify potential projects/solutions

Requirements:

College/Technical School diploma in pharmaceutical manufacturing, science, or related field
Bachelor's of Science or Bachelor of Applied Science or related field an asset
2 years of related pharmaceutical experience, preferably in a Manufacturing environment
Previous experience leading training in the pharmaceutical industry an asset

Knowledge, Skills, and Abilities:

Knowledge of cGMP requirements, ability to follow Standard Operating Procedures (SOPs), and pharmaceutical processing regulations
Strong team building and organization skills
Excellent computer skills, including the ability to develop spreadsheets, presentations, and reports
Excellent written and oral skills
Detail-oriented and organized, with a high degree of accuracy and thoroughness
Excellent interpersonal skills
Proficiency with Microsoft Office
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 Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP)
Maintain workspace in a clean and orderly fashion
Effectively 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 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 related fields

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about lab/lab office locations
Ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time
Manipulation (lift, carry, move) of light to medium weights of 10-35 pounds
Arm, hand, and finger dexterity, including ability to grasp and type for prolonged periods of time
Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time
Ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time
Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally

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