We have a one-year contract opportunity for a BSc-level Quality Assurance Associate to join the Quality Operations Division. The successful candidate will be a key contributor to the organization, administration and execution of the quality system in place at Custom Biologics.
Custom Biologics is an innovative and rapidly growing biopharmaceutical contract testing laboratory located in Toronto, Canada. We are a Health Canada audited, GMP-compliant, global service provider for functional testing of biotherapeutics, biosimilars and antibody drug conjugates. Since 2004 our scientists have been designing and validating sophisticated bioanalytical assays to characterize and measure the therapeutic potential of large and small molecule biotherapeutics. Our work supports regulatory drug submission applications from global biopharmaceutical companies.
Scientific excellence[CM1] and uncompromising quality are the pillars of the Company. The ideal candidate will be joining a team of highly motivated individuals and a workplace culture driven by collaboration, achievement, quality and growth. S/he is highly motivated with a strong ‘can-do’ personality, excellent laboratory, critical thinking, results driven, and works well within a team to deliver excellence to our clients.
KEY DUTIES AND RESPONSIBILITIES
· Maintain the Quality System by adhering to Standard Operating Procedures (SOPs).
· Issue controlled forms and maintain document control.
· Assist with management and organization of laboratory documentation.
· Conduct data review activities prior to issuing Certificates of Testing/Analysis, Analytical Reports and Study Reports.
· Prepare and review SOPs and study documentation to ensure compliance with current procedures and regulatory requirements.
· Ensure changes are properly documented through change control procedures.
· Prepare and file deviation reports and assist analysts with out of specification or suspect result investigations.
· Contribute to the validation of computerized systems by performing 21 CFR 11 compliance checklists, preparing risk assessments, and assessing user permission levels prior to finalizing SOPs.
· Provide support to Lab Operations, as needed, by assisting with:
· Preparation of equipment qualification (IQ, OQ, PQ) documentation
- Equipment maintenance and calibration
- Performing daily temperature verification checks (fridges, freezers, incubators, cryopreservation tanks, lab space, etc), as required
- Maintaining up-to-date inventories of all temperature-controlled units
· Perform data restoration checks to verify the completeness/accuracy of the backup data.
· Perform vendor qualifications following established procedures.
· Liaise with other lab personnel about quality-related matters.
· Assist with general lab and housekeeping routines.
· Ensure Excel spreadsheets are validated following written procedures, as required.
· Maintain the confidentiality of all documents pertaining to the work conducted at the company.
· Participate in training activities pertaining to this position and the overall Quality System and maintain complete and accurate training records.
· Maintain compliance to health and safety standards, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) and Custom Biologics’ Quality System.
· Other duties as assigned.
SKILLS & COMPETENCIES
· Excellent interpersonal, verbal and written communication skills.
· Advanced technical report writing capabilities.
· A proven ability to be highly productive and successful in a high pace work environment with excellent attention to details.
· Competency in computer skills and familiarity with Microsoft Office programs (Word, Excel, Project, PowerPoint).
· Self-motivated and comfortable working in a fast-paced environment
· Excellent team player. Willing to support co-workers with other projects. Shares relevant information and seeks technical advice and input when necessary.
· Willing to accept temporary responsibilities outside of initial job description.
EDUCATION & EXPERIENCE:
· A minimum of a BSc in biological sciences required.
· Post-graduate diploma or certificate in Quality Assurance preferred.
· Industry experience as a laboratory technician/technologist or pharmaceutical quality assurance associate considered an asset.
· Working knowledge of FDA, ICH and Health Canada guidelines and regulations pertaining to pharmaceutical GMPs.
· Familiarity with GMP/GLP regulations is desired but not required.
WORKING CONDITIONS
· Successful candidate will be working in a controlled regulatory compliant biosafety level 2 laboratory environment and office.
· Work may periodically require attending to experiments outside standard working hours.
The annual salary range for this position is $50,000 to $60,000, commensurate with qualifications and relevant experience.
Please submit resume and cover letter to [email protected].
Custom Biologics is an equal opportunity employer. Only those candidates considered for employment will be contacted.
Pay: $50,000.00-$60,000.00 per year
Benefits:
- Dental care
- Extended health care
- Vision care
Ability to commute/relocate:
- Toronto, ON: reliably commute or plan to relocate before starting work (required)
Education:
- Bachelor's Degree (preferred)
Licence/Certification:
- post-graduate diploma or certificate in Quality Assurance (preferred)
Work Location: In person
