ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications. ViaCyte’s product candidates are based on the derivation of pancreatic progenitor cells from stem cells, which are then implanted in durable and retrievable cell delivery devices. Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels. ViaCyte has two product candidates in clinical-stage development. The PEC-Direct™ product candidate (also known as VC-02) delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes. The PEC-Encap™ (also known as VC-01) product candidate delivers the same pancreatic progenitor cells in an immunoprotective device and is being developed for all patients with diabetes, type 1 and type 2, who use insulin. ViaCyte is also developing immune-evasive ‘universal donor’ stem cell lines, from its proprietary CyT49 cell line, expected to further broaden the availability of cell therapy for diabetes and other indications. ViaCyte is headquartered in San Diego, California. The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF. For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.
The QA Specialist will support ViaCyte’s clinical and manufacturing development activities by ensuring that ViaCyte’s quality systems/procedures are following the applicable regulations/standards (e.g., US FDA, EU, and Canada). The QA Specialist will communicate and interact with cross-functional teams by providing support in the following activities: supplier management, employee training, internal/external audits, SOP development and review, design control, statistical analysis, and other quality activities that may be assigned by Quality Management.
Essential Duties & Responsibilities
1. Provides support in supplier management activities (e.g., continuous monitoring of supplier performance, analyze supplier trends and coordinate improvement activities, maintenance of supplier files, monitoring of change notifications from suppliers, etc.). Presents supplier status to Quality Management.
2. Responsible for SOP development/revision and evaluation of their appropriateness in the development phase.
3. Assists in the review of batch records and ensures that the review observations/comments noted during review are documented and communicated to the appropriate personnel to prevent future document errors/discrepancies.
4. Conducts internal and external audits to maintain compliance with ViaCyte procedures and applicable regulations and ensure active follow-up on findings/recommendations including CAPAs observed during the audits.
5. Develop metrics on audit findings and provides report in preparation for Management Review Meeting.
6. Coordinates the training of all GMP employees and ensure that training is conducted in sufficient frequency and develops methods on how to evaluate QA-led training effectiveness of employees.
7. Assists in the coordination and scheduling of Management Review Board (MRB), Change Control Board (CCB), and Quality System Incidents Review Board (e.g., deviations, NCMRs, OOS, etc.).
• Experience working in a team environment and with proven ability to provide guidance that will promote good communication and cooperation among different teams.
• Strong knowledge of FDA and international regulations and standards.
• Must be skilled in Microsoft Office, including Word and Excel, with PowerPoint experience and Visio are preferred.
• Strong verbal and written communication skills are required.
• Self-motivation and independent initiative while often working without the benefit of established procedures.
• Strong knowledge of statistical techniques with relevant experience in data analysis, and trending quality metrics for continuous improvement.
• Must possess mobility to work in laboratory and office settings and to use equipment commonly found in these environments.
• Compliance with GMP protocols is required in certified cleanrooms.
• Laboratory and office space requiring adherence to standard safety and laboratory practices, with possible exposure to chemicals, blood borne pathogens, and other risks typically associated with working in a biological sciences research facility.
• A bachelor’s degree in a scientific or related discipline, or a certification in a quality discipline (e.g., CQE, CQA).
• A minimum of 7 plus years of relevant work experience in biologics, combination product, medical device or pharmaceutical product manufacturing is strongly preferred.
For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code 2021-18 and your full name. Send to firstname.lastname@example.org. Our mailing address: ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.
It is the policy of ViaCyte to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, ViaCyte will provide reasonable accommodations for qualified individuals with disabilities.
ViaCyte’s goal is to increase representation of women, people of color, veterans and individuals with disabilities. Our programs are designed to comply with all applicable federal, state and local laws, directives and regulations and cover all human resource actions including employment, compensation, benefits, training, education, promotions and social/recreational programs.