Technical Writer I - Operations

How will you make an impact?

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe and you’ll be valued and recognized for your performance. With dedicated managers and inspiring coworkers to support you, you’ll find the resources and opportunities to make significant contributions to the world while building a vibrant career!

What will you do?

Prepare and revise Standard Operating Procedures (SOPs) based on Deviation Reports(DR)/ Corrective Action Preventative Action (CAPA) and Change Control (CC) initiatives within the ops department. Assist Production Management (Processing or Packaging) groups through the completion of
Administrative tasks as assigned.

Responsibilities:

• Review, revise and prepare procedures/SOPs for compliance with Good Manufacturing Practices (GMP) and to reflect current work activities in the Operations department
• Ensure procedures/SOPs for the Operations department are of sufficient detail for technical content, accuracy, clarity, completeness, and flow. In particular, procedures in response to Tri-Annual Reviews, DRs, comments/audits by clients and regulatory agencies, change controls (CCs), new/modified equipment, and general changes in procedures
• Ensure SOPs are regularly reviewed and kept up to date with proper approvals
• Coordinate with Compliance Department to ensure SOPs are reviewed and revised appropriately and training is provided
• Work with Technical Operations, PPT Engineers and processing and packaging departments in the generation and approvals of SOPs and CCs.
• Work closely with quality and investigations to understand requirements for each CAPA/DR/SOP.
• Track the 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 coordinator
• 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

How will you get there?

Requirements

Education:

• College/Technical School diploma in pharmaceutical manufacturing etc.
• Bachelor of Science or Bachelor of Applied Science or related field an asset

Experience:

• 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 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.
• Diligent and organized, with a high degree of accuracy and thoroughness.
• Excellent interpersonal skills.
• Proficiency with Microsoft Office.
• Proficiency with the English language.

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or augmenting efficiency in their laboratories, we are here to support them. Our distributed team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. We share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve sophisticated scientific challenges, drive technological innovation and support patients in need. #StartYourStory at ThermoFisher Scientific, where diverse experiences, backgrounds and perspectives are valued!

Apply today! Please visit us at http://jobs.thermofisher.com

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.