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 Stability Coordinator – Vaccines and Biologics
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.
Position Overview:
This role is responsible for successful management of stability programs at Biodextris following established Standard Operating Procedures and in accordance with Good Manufacturing Practice (GMP) guidelines, United States Pharmacopeia (USP) monographs and ICH guidelines.
The Quality Control Stability Coordinator will support new and established product stability studies through scheduling, monitoring and direct interaction with project managers. This position is offered as a permanent position.
Specific Responsibilities:
- Plans and monitors samples stability studies
- Reviews specifications, stability plans and stability reports
- Performs stability data trending
- Prepares / reviews certificates of analysis
- Documents deviations to the stability plans
- Notifies senior staff of sample non-conformances, protocol deviations and other major issues.
- Participates in investigation regarding OOS and atypical results
- Coordinates analytical samples reception and shipment
- Ensures proper samples storage
- Coordinates sample inventories and sample destruction
- Assess the impact of temperature excursions
- Collaborate with Supervisor to optimize QC processes.
- Adhere to GMP laboratory dress code requirements.
- Ensure that all safety guidelines are followed strictly and maintain a clean and orderly environment.
- 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.
- Report any out-of-specification (OOS), out-of-trend (OOT) or irregularities immediately to the Supervisor and participate in laboratory investigations, as required.
- 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
- Experience in sample management or in quality is a plus
- Experience in CRO is a plus
- Direct experience in the following:
- Following GMP guidelines
- Following Standard Operating Procedure
- GMP Documentation
- Writing and reviewing of deviations
- Sample handing and documentation procedures