MUST BE CURRENTLY ELIGIBLE TO WORK IN CANADA. This is not a remote position, candidate must be willing to work in Laval, Quebec.
Quality Control Technical Writer – Vaccines and Biologics
Employment Type: Full-time
Biodextris is a rapidly growing Contract Development and Manufacturing Organization specializing in biologics and vaccines. Specific service areas include analytical method development, molecular characterization, Quality Control testing, bioprocess development, and GMP manufacturing services for products in research, pre-clinical and early-phase clinical studies. Biodextris is a quality driven, responsive partner with strong global experience and deep scientific expertise. Our mission is to offer to our client transparency and a collaborative approach.
Biodextris is currently seeking a Technical Writer – Quality Control who under minimal supervision, will author and revise deviations, preventative actions, change controls, SOPs and other related cGMP documents associated to the analytical services division of the company. The Technical Writer – Quality Control will work in collaboration with Quality and Analytical Subject Matter Expert’s to support deviation investigations, root cause analysis and effective corrective preventative actions (CAPA). Compliance with established GMP, safety, and regulatory regulations is required.
This position is offered as a permanent position.
- Under minimal supervision, authors and revises deviation records, preventative actions and other related cGMP documents in a timely manner.
- Becomes familiar with analytical method development and qualification processes, stability testing, materials management, systems, and technologies to facilitate the accurate completion of responsibilities.
- Track/monitor and provide timely, accurate information regarding status of open tasks.
- Actively engage in Inspection Readiness activities and teams.
- Provide guidance to write and revise SOPs (Standard Operating Procedures) when gaps are identified.
- May provide support to internal and client audits as needed.
- Responsible for exhibiting professional behavior with internal and external associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Collaborate with Supervisor to optimize QC processes.
- Creates and reviews quality procedural documents and change control documents
- Follow company policies and procedures.
- Complete SOP training for new and revised procedures prior to activity performance.
- Adhere to established security policies.
- Maintain Good Documentation Practices when completing GMP documents.
- Maintain personal training file and assist in training of other staff.
- Perform additional duties as assigned.
Required Education skills and abilities:
- Minimum Education: BSc in life sciences with a minimum of 7 years experience
- Minimum of 2 years of relevant experience in cGMP quality control, documentation, biology, quality assurance, or equivalent
- Possess knowledge, understanding, and application of cGMP’s as it relates to Clinical and operations
- Experience in writing of deviations, CAPAs, Standard Operating Procedures
- Detail oriented and proficient in Microsoft Office applications
- Strong listening and interpretive skills to successfully translate events into clearly written documents
- Ability to work independently, within prescribed guidelines, or as a team member to meet timelines for completion and approval of documentation
- Experience in CRO is a plus
Application: Send resume and cover letter by email to firstname.lastname@example.org.