Come and join our dynamic team of highly skilled, passionate, creative professionals who together are advancing rare cell diagnostics and making precision medicine a reality.
ANGLE has unique technology addressing critical needs in the rapidly growing liquid biopsy market which provides a simple and effective way to capture circulating tumor cells from cancer patient blood. The technology is being commercialized in both Europe and North America – initially to the research market.
ANGLE Biosciences is conveniently located near Pearson International Airport with access to some of Canada’s best academic and health researchers in the Greater Toronto Area.
We are an equal opportunity employer and provide a challenging and stimulating workplace environment.
The Quality Systems Associate performs quality functions and procedures, provides documentation control, works to resolve Quality related process issues by reviewing standard operating procedures, work instructions and performing audits as required
Essential Duties and Responsibilities:
- Coordinate product releases in compliance with cGMPs and company SOPs
- Monitor conformance to GMP under Quality System guidelines, compliance with ISO standards and adherence to organizational health/safety policies in the operational processes on a daily basis
- Monitor the implementation of Standard Operation Procedure (SOP) and update the SOPs in collaboration with other functional departments as needed
- Monitor and control acceptance of incoming materials and equipment
- Participate in qualification of suppliers
- Participate in validation of manufacturing processes and equipment qualification
- Participate in in-house calibration of measuring equipment and external calibration activities
- Ensure full documentation on QA related issues
- Work closely with R&D in identifying the needs of validation and perform the testing on operation process, materials or manufacturing equipment as needed.
- Maintain and update documents such as QA files, QC inspection records, production batch records, validation documentation, supplier notification, internal change notification, customer complaint history, and testing/validation reports
- Participate and support documentation for the regulatory audit, internal audit, management reviews, and supplier evaluation meetings
- Participate in change control procedures and administration of SOP
- Log complaints, work with complaint documentation
- Maintain QA related manufacturing records
- File and maintain in order QA records
- Maintain calibration and qualification records
- Coordinate maintenance of QA related equipment and measuring devices
- Maintain quarantined devices and raw materials
- Participate in corrective and preventive action activities. Maintain CAPA records
- Participate in design controls, verification and validation strategies in compliance with relevant regulatory guidelines and with minimal supervision
- Control and/or conduct in-process and final test related to the manufacturing of the consumables and reagents.
- Participate in verification and validation activities
- Perform such other duties and responsibilities that are consistent with the role of a Quality Systems Associate or as may be assigned from time to time
Required Experience, Education and Knowledge:
- in Life Sciences OR an equivalent combination of commercial experience and formal education
- 3 years’ experience working in a regulated environment in biomedical or pharmaceutical industry
- 1-3 years research lab experience, preferably in an industrial biotechnology or diagnostic company operating in a regulated manufacturing environment
- Familiarity with Canadian and international regulatory and quality assurance regulations
- Experience operating in an ISO certified environment
- Proficient in Microsoft Office (Excel, Word, Project, PowerPoint)
- Strong scientific/technical aptitude
- Exemplary customer service and interpersonal skills
- Good visual inspection skills combined with tolerance for repetitive work
- Strong verbal and written communication skills
- Ability to multitask and prioritize to meet deadlines
- Ability to work both independently with minimal supervision as well in a team environment
- An eye for detail and commitment to high quality data
- Continuous learner with a keen appetite for cross-disciplinary work
- Flexibility and a “can do” attitude
- Entrepreneurial thinking and work ethic
How to Apply
Please submit your resume, along with a cover letter to jobsABI@angleplc.com or apply directly to our website at https://angleplc.com/careers/
Please reference the position: “Quality Systems Associate”.
All applications will be kept confidential. We thank all candidates for their interest, but only candidates selected for an interview will be contacted.
Please NO recruiters.
At ANGLE Biosciences we value diversity and encourage applications from all qualified candidates including women, visible minorities, Aboriginal peoples, and persons with disabilities.
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.