Operations Technical Writer - 12 month contract
- Whitchurch-Stouffville, ON, Canada
The typical hiring range for this position is $60,480-$75,600. · Full-time
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Job details
- Pay
- The typical hiring range for this position is $60,480-$75,600.
- Job type
- Full-time
- Apply by
- Posting language
- English
- Posted
Original job description
We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.
Our Team, Your Impact
We are seeking an Operations Technical Writer to support our Manufacturing team in a GMP-regulated pharmaceutical production environment. In this role, you will be responsible for creating, revising, and maintaining controlled manufacturing documentation while supporting investigations related to deviations, non-conformances, and quality events. This position is ideal for someone who enjoys technical writing, problem-solving, and collaborating across multiple departments to drive compliance and operational excellence.
How You’ll Spend Your Day
Technical Documentation
- Author, revise, and maintain controlled GMP documentation, including:
- Standard Operating Procedures (SOPs)
- Work Instructions (WIs)
- Job Aids
- Equipment Manuals
- Cleaning Procedures
- Manufacturing Support Documents
- Forms and Templates
- Training Materials
- Ensure documents meet site quality standards, formatting requirements, and regulatory expectations.
- Translate complex technical processes into clear and user-friendly instructions for operational personnel.
- Lead and support investigations involving manufacturing deviations, non-conformances, procedural events, equipment issues, and quality concerns.
- Gather and assess information from batch records, equipment logs, electronic systems, environmental data, and employee interviews.
- Perform Root Cause Analysis (RCA) using tools such as:
- 5 Whys
- Fishbone Diagrams
- FMEA
- Assess impact on product quality, compliance, patient safety, and operational performance.
- Author investigation reports and support timely closure of quality events and CAPAs.
- Develop and update training materials.
- Partner with subject matter experts to document best practices and manufacturing standards.
- Support document lifecycle management within electronic quality management systems.
- Promote consistency and standardization across manufacturing documentation.
Your Skills and Experience
- College Diploma in Science or a related discipline.
- Minimum 1 year of experience in a GMP-regulated pharmaceutical, biotechnology, medical device, or manufacturing environment.
- Experience authoring and revising controlled documentation.
- Strong technical writing and editing skills.
- Knowledge of Good Manufacturing Practices (cGMP).
- Proficiency with Microsoft Office (Word, Excel, PowerPoint, and Visio).
- Bachelor's Degree in Science, Engineering, or a related field.
- 4+ years of pharmaceutical manufacturing experience, preferably in oral solid dosage manufacturing.
- Experience using quality systems such as TrackWise, Veeva, MasterControl, or similar platforms.
- Experience conducting investigations and developing CAPAs.
- Technical Writing Excellence
- Root Cause Analysis & Investigations
- Critical Thinking & Problem Solving
- Attention to Detail
- Document Control & Quality Systems
- Knowledge of Health Canada, FDA, ICH, and PIC/S GMP requirements
- Understanding of oral solid dose manufacturing processes, including dispensing, granulation, compression, coating, encapsulation, packaging, and cleaning
At Teva Canada we provide a rewarding and collaborative work experience, with career growth and development opportunities for employees, in a safe and caring environment! The typical hiring range for this position is $60,480-$75,600. The base pay offered may vary depending on job-related knowledge, skills, experience, education, and internal equity. In addition to base salary, this role may qualify for an annual bonus based on employment type. Certain positions may also be eligible for a sales commission structure as part of the overall compensation package. Beyond base pay, Teva also offers a comprehensive suite of wellness and benefits programs tailored to role and employment type, that continue to rank among the best in our industry! Our competitive offerings are designed to provide flexibility, security, and meaningful choices, empowering employees to thrive both personally and professionally throughout their journey with us.
As part of our commitment to well-being, employees may have access to:
- Teva Canada’s choices Benefit Plan including Health, Dental, Disability, Life Insurance
- Employee Assistance Program & Virtual Health Programs
- Retirement Savings Programs
- Employee Stock Purchase Plan (ESPP)
- Time for yourself or those you care about, through paid time for Vacation, Wellness days, Care/Sick days, Teva Days and Volunteer Days
- Education Assistance Program
- Recognition programs such as Employee Service Awards
- Employee Discounts
- And much more!
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Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
More about this job
Responsibilities
Create, revise, and maintain controlled GMP manufacturing documents, training materials, and related records, ensuring they meet site quality and regulatory requirements. Lead or support investigations into manufacturing and quality events, perform root cause analysis, assess impacts, and help close investigations and CAPAs.
Requirements
A college diploma in science or a related discipline and at least one year of experience in a GMP-regulated pharmaceutical, biotechnology, medical device, or manufacturing environment are required. Candidates should have controlled-documentation experience, strong technical writing skills, and cGMP knowledge; a science or engineering bachelor’s degree, four or more years of pharmaceutical manufacturing experience, and quality-system or investigation experience are preferred.
Skills
- Technical Writing
- Controlled Documentation
- Good Manufacturing Practices
- Root Cause Analysis
- Investigations
- Corrective and Preventive Actions
- Document Control
- Quality Systems
- Critical Thinking
- Problem Solving
- Attention to Detail
- Microsoft Office
- Regulatory Compliance
- Training Material Development
- Oral Solid Dosage Manufacturing
Benefits
- Health Insurance
- Dental Insurance
- Disability Insurance
- Life Insurance
- Employee Assistance Program
- Virtual Health Programs
- Retirement Savings Programs
- Employee Stock Purchase Plan
- Paid Vacation
- Wellness Days
- Care and Sick Days
- Volunteer Days
- Education Assistance
- Employee Recognition Programs
- Employee Discounts
Visa sponsorship
Not detected in the job text
Categories
- Manufacturing
- Healthcare
- Science & Research
Keywords
- GMP
- cGMP
- Standard Operating Procedures
- Work Instructions
- Job Aids
- Equipment Manuals
- Cleaning Procedures
- Manufacturing Documentation
- Document Lifecycle Management
- Electronic Quality Management Systems
- TrackWise
- Veeva
- MasterControl
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
- Microsoft Visio
- Root Cause Analysis
- 5 Whys
- Fishbone Diagrams
- FMEA
- Deviations
- Non-Conformances
- CAPA
- Batch Records
- Health Canada
- FDA
- ICH
- PIC/S
- Oral Solid Dosage Manufacturing