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.
This position will focus on quality control activities supporting the manufacture of therapeutic cell products, implantable devices, and cell therapy combination products.
We are currently seeking a QC associate to work in both laboratory and cleanroom environments under strict SOP’s for performing environmental monitoring. Responsibilities include; sampling using EM equipment, sample handling, reporting results with accurate documentation, maintaining database of results, investigation of OOS’s, and determination of root cause as appropriate.
Other responsibilities include quality review and release of all incoming GMP materials; Inventory control management and preventative maintenance activities. Raw material, In-process and lot release sample handling, testing and tracking. Assisting with other duties as needed.
A hands-on approach is required for most job tasks, such as environmental monitoring. Knowledge and experience with aseptic technique is required. The ideal candidate is self motivated, detail oriented, resourceful, flexible and able to handle multiple priorities at once. Flexibility to handle shifts in manufacturing schedules is essential. Weekend work will be required due to the biological nature of the products.
- Adhere to all company policies, quality policies, and SOPs.
- Perform Environmental monitoring.
- EM sample handling.
- Report results and database management.
- Receiving activities for GMP supplies/materials-including proper documentation review, and disposition.
- Quarantine and storage of materials as required.
- In- process and release test sample handling, testing and tracking.
- Raw material sample handling, testing and tracking.
- Inventory control of retains/ raw materials and other QC materials.
- Assist with purchasing general supplies and EM supplies.
- Responsible for preventative maintenance general upkeep of the QC EM equipment and areas.
- Perform other duties as assigned.
- Minimum of 3 years working experience in quality control or environmental monitoring in a biotechnology or pharmaceutical company.
- Experience in an aseptic manufacturing clean room
- College degree in a scientific discipline
- Experience in handling of biological/raw materials.
- Ability to work well in a team environment
- Strong written and oral communication skills
- Excellent record keeping skills and attention to detail
- Must be skilled in Microsoft Windows and Office, including Word and Excel.
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 by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code 2019-13 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.