Quality Assurance Specialist II/III
BlueRock Therapeutics, Canada
Job Description
The Toronto, Canada site is seeking a Quality Assurance Specialist II/III. 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 Quality Assurance Specialist will be responsible for assisting in the development and maintenance of the Quality System (QS) to support the production and testing of cell therapies under current Good Manufacturing Practices (cGMP). Duties include the drafting, review, and approval of documents used to support cGMP manufacturing, performing quality investigations, maintaining the electronic Quality Management System, and other duties as assigned.
Responsibilities:
- Perform quality review of batch records and close-out of deviations
- Lead GMP investigations, CAPA, and change management actions for internal and external manufacturing
- Quality contact for external contract manufacturing laboratories, responsible for Quality oversight of activities performed at third party sites
- Work with Manufacturing, QC, and Supply Chain document the receipt, quarantine, inspection and release of raw materials and manufactured materials used for cGMP manufacturing and QC testing.
- Responsible for release of starting materials, intermediates, drug product and finished goods
- Represent the QA department on CMC and Joint Project Teams
- Draft SOPs and work with team members to draft documents for cGMP manufacturing and Quality Control testing. Review documents and coordinate the document review and approval processes.
- Work with team members to draft, review and approve specifications and protocols for qualification and validation studies. Coordinate review, approval, and archiving of qualification and validation reports.
- Perform risk assessments and close out of engineering work orders for equipment and areas used for cGMP manufacturing.
- Audit internal facilities and systems for compliance to SOPs, cGMP regulations, and other applicable regulations.
- Assist in the development and operation of the Quality Management System, including maintaining and reviewing metrics to monitor performance.
- Other duties as assigned
Requirements
Minimum Requirements:
- Minimum of a Bachelor’s degree in Biology or relevant scientific or engineering discipline
- Minimum of 5 years of hands-on experience in a quality role within a regulated life sciences environment (biotechnology/pharmaceutical/medical device) is required; previous experience with biologics and aseptic processing is highly desired
- Experience with deviations, investigations, CAPA and change control and electronic quality management systems is desired
- Experience with MasterControl is an asset
- Must be detail-oriented with excellent organizational skills
- Strong technical writing skills with working knowledge of MS office programs, such as Word, Excel, SharePoint, Access and Adobe Acrobat professional are required
- Must be self-motivated with the demonstrated ability to work effectively with people from multiple departments, ensure deadlines are met, and manage multiple, potentially changing, priorities.
- Proven ability to identify quality issues and effectively and proactively resolve issues in a team setting.
- Ability to travel if needed to contract manufacturing sites, or to other BlueRock sites in Cambridge, MA and New York City (up to 20%)