Senior Operations Documentation Specialist

2 days ago


Whitby, Canada Thermo Fisher Scientific Full time
Job Overview:
Thermo Fisher Scientific is seeking a highly skilled Senior Operations Documentation Specialist to join our team in Pharmaceutical Manufacturing. This role offers an exceptional opportunity to leverage your expertise in creating and revising Standard Operating Procedures (SOPs) and supporting the operations department in achieving compliance with Good Manufacturing Practices (GMP).

Salary: $60,000 - $80,000 per annum

About the Role:
This position requires strong analytical and communication skills, as you will work closely with cross-functional teams, including Compliance, Technical Operations, and Quality, to ensure SOPs are up-to-date and compliant. Your ability to maintain accurate records, track progress, and identify areas for improvement will be vital to our success.

Key Responsibilities:
- Create, revise, and review SOPs to reflect current work activities and ensure compliance with GMP requirements
- Collaborate with the 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
- Identify process improvements and provide recommendations to enhance operational efficiency
- Maintain accurate records, track progress, and identify areas for improvement

Requirements:
- 2 years of related pharmaceutical experience, preferably in a manufacturing environment
- College/Technical School diploma in pharmaceutical manufacturing, science, or a related field; Bachelor's of Science or Bachelor of Applied Science or related field is an asset
- Equivalent combinations of education, training, and relevant work experience may be considered

Preferred Qualifications:
- Previous experience leading training in the pharmaceutical industry
- Strong knowledge of cGMP requirements and pharmaceutical processing regulations
- Excellent computer skills, including proficiency in Microsoft Office and spreadsheet development
- Excellent written and oral communication skills

Benefits:
- Competitive salary range: $60,000 - $80,000 per annum
- Opportunities for professional growth and development
- Collaborative and dynamic work environment

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