Quality Assurance Associate

**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.
- Revise SOPs to ensure accuracy with current practice and regulatory requirements.
- 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**
- Work may periodically require attending to experiments outside standard working hours.

**Job Types**: Full-time, Fixed term contract
Contract length: 12 months

**Benefits**:

- Dental care
- Extended health care
- Vision care

Schedule:

- 8 hour shift
- Monday to Friday

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

Expected start date: 2025-07-07