Biodextris in the News

Quality Control Supervisor

MUST BE CURRENTLY ELIGIBLE TO WORK IN CANADA. This is not a remote position, candidate must be willing to work in Laval, Quebec.

Laboratory Support

Lauched in 2015, Biodextris is a specialized contract research and development organization for biological products and vaccines. Technical and consultative services offered include Analytical method development, Molecule characterization, Quality Control testing and Stability Studies, Bioprocess development, and Manufacturing services for products in research, pre-clinical or early-phase clinical applications.  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:

The Quality Control Supervisor is responsible for providing the necessary QC oversight for the clinical manufacturing activities at Biodextris. He or she supports the implementation, execution and maintenance of the Quality Controls analysis and programs ensuring continuous compliance with Canadian, US and European quality compliance regulations and requirements. In the absence of the QA Manager, the Quality Control Supervisor may act as a Deputy Head of Quality.

General Duties

  • Maintain an in-depth knowledge and understanding of current GxPs, including GUI-0036 and GUI-0001
  • Act as a catalyst for change and improvement in performance and quality
  • Ensures that all Gxp-impacting activities are performed in compliance with regulatory requirements and procedures
  • Ensures systems are in place and in use to provide adequate assurance of the integrity of the data generated
  • Ensures that activities, with GxP impact, are compliant

General Departmental Duties (to be performed upon request):

  • Serve as QC Representative, delegate to the QA Manager and Back-up to the QC Reviewer
  • Participated in the QC review and approval of Change Controls, Incidents, Deviations and CAPA’s
  • Support audits of Biodextris by external clients, regulatory bodies and other third parties
  • Oversee/perform internal and supplier audits
  • Maintain QC-related files and databased up to date; ensure that quality-related tasks are captured and follows up with stakeholders for timely completion
  • Manage QC records and documents (rendering documents effective, managing retention policies, records disposal)
  • Manage QC training activities

Role-specific Duties:

  • Schedule QC work, including in-life QC, on a daily basis, maintain it and ensure that it is efficient
  • Support, coach and mentor direct reports in the daily basis for completion of all laboratory studies as scheduled;
  • Work closely with Management to ensure the quality control staff work is efficient, ensure to communicate instructions to staff and ensure procedures are followed and are performed in compliance with protocols, SOPs and GLP’s and all applicable regulations
  • Perform QC review of bioanalytical data and all other QC associated task for bioanalytical project
  • With the collaboration of the subject matter experts, coach and optimize the usage of the software used in the data generation by the QC reviewer.
  • Propose and implement solutions to improve quality, safety and efficiency in the laboratory;
  • Ensure that any issues related to quality control of ongoing studies are resolved in a timely manner and communicate to the Management team;
  • Coordinate quality control training with assigned trainers and perform technical trainings as needed
  • Perform employee evaluations including career path development and provides feedback to Management
  • Observe all company guidelines and policies and keep up to date with respect to pertinent regulatory developments in the industry;
  • Perform any other duties as required

Required Education, Skills and Abilities:

  • B.Sc or equivalent in a Bioprocessing related filed such as Biology, Biotechnology, Biochemistry or Microbiology or equivalent and 8+ year pharma/biotech work experience.
  • At least 4 years prior experience in a QC (manufacturing or release) role, preferably in a biologic or a vaccine manufacturing facility.
  • Experience in the implementation or enforcement of HC GUI-0036 requirements
  • Experience in the implementation or enforcement of HC GUI-0001 requirements or USFDA CFR part 210/211 requirements
  • Experience with USFDA CFR 314 would be an asset

Application: Send resume and cover letter by email to info@biodextris.com.

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