Quality Assurance Specialist (Document Control)
BlueRock Therapeutics, Canada
Job Description
Who is BlueRock?
BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases.
The convergence of cell biology and genetic engineering is creating fundamental new ways to impact disease. Founded in 2016 to capitalize on these technological breakthroughs, we are advancing our novel cell+gene platform to develop, manufacture, and deliver an entirely new generation of authentic and engineered cell therapies across three therapeutic areas: neurology, cardiology, and immunology.
What Are We Doing?
Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit.
We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options.
We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients’ lives.
Description of Position:
The Toronto, Canada site is seeking a QA Specialist focused on Document Control and the maintenance of the QMS.
This is an outstanding opportunity for a talented individual to contribute to bringing a new class of medicines to patients and gain valuable career experience in translational medicine. Collaboration with a highly-motivated, world-class team of scientists and engineers promises an exciting and engaging work environment for motivated, self-starting candidates.
The QA Specialist will be responsible for assisting in the maintenance of the Quality Management System (QMS) to support the production and testing of cell therapies under current Good Manufacturing Practices (cGMP). Duties include maintaining GMP documentation and coordinating the revision, review, issuance, and approval of SOPs and other GMP documents that are necessary for ensuring compliance with applicable U.S., Canadian and global standards.
Responsibilities:
- Issuance of controlled documents, document tracking, processing, and archiving.
- Provide support to other team members for document change control and coordinate the revision, review, and approval of SOPs and other GMP documents.
- Assign, schedule and support training of new hires and current staff, maintain training files
- Assist in organizing and maintaining accurate and reliable systems for archiving cGMP records in paper and/or electronic format.
- Provide support for coordinating review, approval, and archiving of qualification and validation reports.
- Assist in notebook issuance and data archival activities.
- Other duties as assigned
Requirements
- BS in Biology, Biochemistry, Engineering, or related field.
- 2+ years of experience working in document management in a regulated industry (life sciences and/or med device preferred) with direct document control experience.
- Experience with Good Documentation Practices is required. Experience reviewing cGMP documentation is highly desirable.
- Must be well-organized and proficient at reviewing and editing documentation.
- Can maintain excellent attention to detail while executing multiple tasks.
- Excellent written and oral communication skills and the
- Strong technical writing skills with working knowledge of MS office programs, such as Word, Excel, SharePoint, Smartsheet and Adobe Acrobat professional are required
- Self-motivated with the demonstrated ability to work effectively with people from multiple departments to ensure deadlines are met, and handle multiple, potentially changing, priorities. Ability and desire to work in a fast paced, dynamic team environment is required.
- Experience with Master Control is highly desirable.
Equal Opportunity Workplace:At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.