QA Specialist

**Quality Assurance Specialist - Document & Change Control: Full Time Position**

Based in Dartmouth, Precision BioLogic is a privately held medical device company that develops, manufactures, and markets a range of specialty diagnostic products used to assess blood coagulation disorders in clinical laboratories around the world. The company has developed a strong reputation in its niche and counts most of the major hospitals and reference laboratories in North America among its direct customers. On November 1, 2018, Precision BioLogic completed the acquisition of Affinity Biologicals Inc., a primary manufacturer of regents and kits used in hemostasis and thrombosis research and diagnostics located in Ancaster, Ontario.

**We are looking for**:
We are looking for a **Quality Assurance Specialist**who will support our company’s growth. The Quality Assurance Specialist manages documents to a high degree of reliability for security, version, visibility, availability with a controlled reliable audit trail. You will also manage the change control for improvements to quality procedures and processes while supporting GMP compliance and Quality Assurance.

**Your responsibilities**:

- Facilitates the company’s Change Review Board (CRB) meetings, including tracking progress/status for all change control activities.
- Provides Document Management which includes Change Control activities, document distribution, format, copy and file documents, implement change controls, etc.
- Responsible for implementation and maintenance of document control system in the electronic Quality Management System (eQMS).
- Provides QA support including room clearances, GMP document review, writing SOP, etc.
- Manages Archiving Documents.
- Technical Writing.
- Internal Audits.

**Requirements**:

- Works effectively independently and as part of a team.
- Respects the needs of co-workers and other teams.
- Interpersonal skills.
- Communication skills.
- Multi-tasking.
- Attention to detail.
- Flexible and adaptable.
- Time management.
- Desire to learn electronic Quality Management System (eQMS).
- Capable to perform with mínimal supervision.

**Education & Experience**:

- Bachelor of Science
- 1-3 years’ experience working in Quality Assurance Field is preferred
- Experience working in an electronic Quality Management System an asset
- Other equivalent experience and education may be accepted.

Compensation will be commensurate with experience.

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

**Benefits**:

- Casual dress
- Company events
- Employee assistance program
- Extended health care
- Flexible schedule
- On-site parking
- Profit sharing
- RRSP match
- Wellness program

Schedule:

- Day shift
- Monday to Friday

**Education**:

- Bachelor's Degree (required)

**Experience**:

- Quality Assurance: 1 year (required)

Work Location: In person

Application deadline: 2025-06-13