Content Writer

About BioVectra

BioVectra is a pharmaceutical company that seeks a skilled Technical Author to join its team.

The successful candidate will be responsible for creating and managing technical documents, working with the project team, and ensuring compliance with cGMP guidelines. They will also provide training to manufacturing employees and conduct orientation for new employees.

Salary

The estimated annual salary for this position is $80,000 - $100,000 based on industry standards and location.

Job Description

The Technical Author will be responsible for:

• Writing and managing the change control of technical documents that directly support manufacturing and special projects.
• Working with the project team in identifying specifications and requirements for materials/equipment destined for use in the manufacture of APIs.
• Ensuring documentation is in place for management of receipt, traceability and compliance under cGMP guidelines.
• Consulting and communicating with suppliers and external sales reps concerning the technical details of the scope of service or deliverable and aligning internal documents accordingly through new document creation or change control.
• Preparing validation protocols, associated reports, and other documentation required to support the successful execution of projects.
• Providing training to manufacturing employees and conducting orientation for new employees in standard operating procedures and technical process procedures.
• Facilitating continuous improvement and best practice development within the Production unit.
• Preparing spreadsheets to track critical project data, preparing summary reports, and identifying process improvement opportunities using statistical methods.
• Working with the project team in the identification of instruments, equipment and process aids for the maintenance and manufacturing departments for the Facility and recommending supplier options.
• Providing administrative support for the facility staff and sourcing, purchasing, negotiating equipment and process aids for API processes.
• Adhering to BIOVECTRA's Health and Safety Policy as outline in CP0010 Occupational Health and Safety Policy, Statements of Principle, and Responsibilities.
• Additional duties assigned, based on business needs and the department manager's request.

Required Skills and Qualifications

To be successful in this role, the candidate should have:

• Postsecondary education in technology, science, or related field.
• Two (2) years' experience working in the pharmaceutical industry.
• Familiarity with Q7A "Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients" and the ability to apply the Q7A guidance to project requirements is desired.
• One year of technical writing experience considered an asset.

Benefits

BIOVECTRA offers a competitive benefit package, including health insurance, retirement plans, and paid time off.

Others

We value diversity and recognize that experience comes in many forms and skills are transferable. Please view this description as a general overview, but not a mandatory comprehensive list.