Document Control Specialist Ii

6 days ago

Markham, Canada Fluidigm Full time

**Job Description**:
**Would you like to join an innovative team creating technology to power groundbreaking insights in academic, clinical, pharma and biotech research?**

It is an extraordinary time for Standard BioTools. Our technology is empowering customers to improve life through comprehensive health insight. We invite you to join a leading provider of indispensable life sciences tools that is accelerating global research on multiple frontiers of human health.

At Standard BioTools, we are building a positive culture where our people can do the best work of their careers, informed, and influenced by our core behaviors:

- Keep customers front and center in all of our work
- Be accountable and deliver on commitments
- Drive continuous improvement
- Be collaborative and work as one team: fostering communications in a learning, coaching, and helpful environment

Standard BioTools is looking for a **Document Control Specialist II.** This is a hybrid role (work from home and office), and it will support multiple executives located in the US. This position works cross-functionally to support efforts to setup and maintain a centralized document management system. In this role you will manage day-to-day documentation strategies, training, and activities to ensure compliance to medical device ISO 13485 requirements.

**Description**:

- Coordinate the site’s document Change Order processing (CO), tracking, review, approval, distribution, and archiving.
- Manage document control/quality system activities using ComplianceQuest (CQ) Software.
- Review documents for accuracy, completeness, and compliance.
- Administrate the company’s Electronic Quality Management System (users’ permissions ,access sets, training groups, etc...).
- Assist with the authoring and revision of quality system procedures, item specifications, SOPs and forms; identify changes needed for existing documentation and processes to support continuous improvement.
- Coordinate site’s day-to-day quality assurance documentation activities to ensure compliance to ISO 13485.
- Implement Quality Records management policies.
- Monitor, conduct and maintain employee training as required for quality system compliance. As applicable, conduct training on use of ComplianceQuest Software.
- Administration and tracking of site’s Product Device Master Record (DMR) and Design History File (DHF) quality management activities.
- Serve as a change agent, assisting associates’ company-wide with understanding and adopting records management practices in alignment with recommended policies.
- Performs filing and scanning of quality system documentation.

**Minimum requirements**:

- Knowledgeable about quality practices and procedures, including 21 CFR Part 820, other FDA Regulations and ISO 13485.
- Bachelor's Degree in Biochemistry, Biology, Chemistry, Engineering or equivalent knowledge gained through industry experience.
- Understanding and working with electronic, documentation systems at the same time.
- Clear proficiency at composition, reviewing and editing documentation; developing and maintaining accurate tracking systems
- Knowledge in Good Documentation Practices (GDP).
- Proven ability to maintain attention to detail and organization
- The Company is committed to providing an inclusive and barrier free recruitment process to applicants with accessibility needs in accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act (AODA). If you require an accommodation during this process, please inform The Company of your requirements. We are an equal opportunity employer._

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