Associate, Quality Assurance
ViaCyte, Inc., a leader in the emerging field of regenerative medicine, is a private, venture-capital backed company headquartered in San Diego, California, focused on profoundly improving the way patients with diabetes are treated. For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.
Under limited supervision, incumbent shall utilize their Quality Assurance experience in the medical device and/or pharmaceutical industry to support the Quality Management System for a complex combination product while ensuring compliance with both medical device and biologic product regulations and ISO 13485 standards.
1. Perform QA review of manufacturing and QC batch documentation and disposition of final and intermediate product lots.
2. Perform QA review of executed Quality Records.
3. Assist with internal and regulatory audits/inspections to comply with FDA and ISO 13485 requirements.
4. Implement discrepancy management program by performing investigations, root cause analyses, and tracking implementation of corrective and preventative actions, as required for Deviations, NCMRs, CAPAs, and other Quality Incidents.
5. Throughout the course of all job activities, maintain accurate records and documentation required to support regulatory submissions and comply with regulatory requirements and the QMS.
Bachelor’s degree in science preferred with 3+ year’s Quality Assurance experience and/or training or equivalent combination of education and experience in a regulated environment. Pharmaceutical or biologics experience desired.
- Must be self-motivated, detail-oriented, and have demonstrated success with managing multiple priorities.
- Working knowledge of US and European medical device regulatory requirements, including ISO 13485 requirements. Experience with US, Canadian and EU GMP requirements.
- Experience working with combination products desired.
- Must be skilled in Microsoft Office, including Word and Excel. PowerPoint experience is helpful.
- Strong verbal and written communication skills are required.
- Be able to be gown qualified for entry into controlled manufacturing areas to perform quality functions as assigned. Provide floor support for GMP activities
- Must possess mobility to work in laboratory and office settings and to use equipment commonly found in these environments.
- Strength to lift and carry equipment and supplies weighing up to 30 pounds.
- Vision to read printed materials and a computer screen; and hearing and speech to communicate in person and over the telephone.
Our dynamic workplace is attractive to those who are self-motivated and resourceful. You will be expected to set priorities within your job scope and to meet critical deadlines. Flexibility to handle rapidly changing objectives and timelines is essential.
For submission through BioSpace portal, please attach your resume and cover letter as a Word or PDF file.
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.