Technical Document Specialist

7 days ago

Windsor, Ontario, Canada BioVectra Full time
Job Overview:

The successful candidate will play a crucial role in the development and maintenance of technical documents that support manufacturing and special projects at BioVectra. This position requires strong communication skills, attention to detail, and the ability to work collaboratively with cross-functional teams.

About Us:
BioVectra is a leading biopharmaceutical company dedicated to delivering high-quality products and services to our clients. We are committed to creating an inclusive environment and building a team that represents a variety of backgrounds, perspectives, and skills.

Job Description:
  • Develop and manage technical documents that directly support manufacturing and special projects.
  • Collaborate with project teams to identify specifications and requirements for materials/equipment used in the manufacture of APIs.
  • Ensure documentation is in place for management of receipt, traceability, and compliance under cGMP guidelines.
  • Consult with suppliers and external sales reps concerning technical details of scope of service or deliverable and align internal documents accordingly.
  • Prepare validation protocols, associated reports, and other documentation required to support project execution.
  • Provide training to manufacturing employees and conduct orientation for new employees on standard operating procedures and technical process procedures.
  • Facilitate continuous improvement and best practice development within the Production unit.
  • Prepare spreadsheets to track critical project data, prepare summary reports, and identify process improvement opportunities using statistical methods.
  • Work with project teams to identify instruments, equipment, and process aids for the maintenance and manufacturing departments.
  • Provide administrative support for facility staff and source, purchase, and negotiate equipment and process aids for API processes.

Required Skills and Qualifications:
  • Postsecondary education in technology, science, or related field.
  • Two years' experience working in the pharmaceutical industry.
  • Familiarity with Q7A 'Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients' and ability to apply guidance to project requirements.
  • One year of technical writing experience considered an asset.

Benefits:
We offer a competitive salary and benefit package to our employees. If you feel passionate about our efforts and believe you have the skills to contribute and lead in this role, we encourage you to apply.

Estimated Salary:
$80,000 - $110,000 per annum

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