MUST BE CURRENTLY ELIGIBLE TO WORK IN CANADA. This is not a remote position, candidate must be willing to work in Laval, Quebec.
Analytical Quality Control Specialist
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.
Quality Control Specific Responsibilities:
- Follows company policies and procedures.
- Completes SOP training for new/revised procedures prior to activity performance.
- Maintains an up-to-date curriculum vitae (CV) and training records.
- Reports any deviations from effective procedures and policies, OOT/OOS, in a timely manner.
- Adheres to physical and logical security policies.
- Ensures cGMP compliance.
- Ensures the integrity and traceability of data generated.
- Practices safe work habits and adheres to company safety procedures and guidelines.
- Maintains a current working knowledge of the regulatory environment and requirements.
- Participates to Laboratory Investigation and CAPA process when needed.
- Works in alignment with specific objectives and priorities from lab management.
- Performs QC testing for the purpose of material/product release and/or stability protocols, according to testing schedule and priorities.
- Responsible for maintenance of accurate documentation of all project work according to internal procedure.
- Participates in the review of new versions SOPs.
- Participates in performing technical training, as requested.
- Participates in Laboratory Investigation and CAPA testing plan, when needed.
- Collaborates with lab management to optimize laboratory efficiencies, maintain a clean environment, and adopt an appropriate Dress Codes in Laboratory and GMP areas.
Required Education skills and abilities
- Education: Minimum BSc
- Experience: 2+ years in GxP compliant laboratory activities.
- Experience with a broad array of immunoassay and physicochemical techniques, instrumentation, sample handling and preparation, interpreting of data, and adherence to objectives/timelines.
- Technical knowledge in key areas sufficient to enable QC testing for physicochemical and immunogenicity assays.
- Ability to maintain clear and efficient method development documentation.
- Ability to follow scientific directions, participate in technical training for new employees and colleagues.
- Ability to complete documentation per GMP (Good Manufacturing Practices) requirements.
- Ability to adhere to SOPs (Standard Operating Procedures).
- Ability to follow verbally communicated or draft procedures.
- Experienced in all routine laboratory procedures.
- Excellent attention to detail, team worker and communication skills.
- Ability to establish and maintain effective working relationships with coworkers and managers.
- Must be proficient in using various types of computer software (Word, Excel. PowerPoint & Outlook).
- Proven ability to manage and coordinate multiple projects in a fast-paced, highly professional environment.