Quality Assurance Associate

3 weeks ago

Toronto, Canada Custom Biologics Full time

This is an exciting growth opportunity for a BSc-level scientist to join the Quality Assurance group at an innovative and rapidly growing biopharmaceutical contract testing laboratory located in Toronto, Canada.

**KEY DUTIES AND RESPONSIBILITIES**
- Assist with management and organization of laboratory documentation.
- Issue controlled forms and maintain document control.
- Perform vendor qualifications following established procedures.
- Revise SOPs for clarity and to ensure accuracy with current practice and regulatory requirements.
- Ensure changes to the Quality Systems are documented through change control procedures.
- Initiate CAPA’s resulting from deviations, identified non-conformances, and audit observations.
- Prepare and file deviation reports and assist with the documentation of OOS investigations.
- Assist with responses to external, internal and audit observations.
- Assist with qualification (IQ, OQ, PQ) and verification of instruments; ensure all equipment is maintained and within calibration.
- Conduct data review prior to issuing Certificates of Testing, Analytical Reports and Study Reports.
- Perform data restoration checks to verify the completeness/accuracy of the backup data.
- Maintain up-to-date inventories of all temperature-controlled units.
- Liaise with other lab personnel, scientists, suppliers, clients/customers about quality-related matters.
- Assist with general lab and housekeeping routines.

**INTERPERSONAL SKILLS/CONTACTS**
- Excellent interpersonal, verbal, and written communication skills.
- Self-motivated and comfortable working in a fast-paced environment.
- Excellent team player.
- Willing to accept additional responsibilities outside of initial job description.

**WORKING CONDITIONS**

**EDUCATION/EXPERIENCE/CREDENTIALS/SKILLS**:

- A minimum of a BSc in biological sciences.
- A minimum of two years of experience as a laboratory technician/technologist or pharmaceutical quality assurance associate.
- 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.
- Working knowledge of FDA, ICH and Health Canada guidelines and regulations pertaining to pharmaceutical GMPs.

**Job Types**: Full-time, Permanent

**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)

**Experience**:

- quality assurance: 1 year (preferred)

Work Location: One location

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