Quality Assurance Specialist
Nano Precision Medical, United States
Job Description
Nano Precision Medical is an emerging biopharmaceutical company located in Emeryville, CA. We develop very small, sub-dermal drug implants utilizing our proprietary NanoPortal TM technology platform which enables delivery of a broad range of medicines to treat chronic diseases for durations of six months or longer. Our products, designed to address poor adherence, will significantly improve patient's lives and provide assurance to the physicians who treat them. Come join us.
In this role, you will be responsible for implementing company and regulatory quality standards for product manufacturing. You are knowledgeable of industry and governmental quality regulations, and have experience conducting audits and reviewing quality data according to existing procedures and document results in required format. You will ensure that Quality Assurance programs and procedures are adhered to and followed to guarantee compliance to cGMP regulations and ICH guidelines. You’ll also work with QA Management to compile/track quality metrics.
To be successful in this role, you must be adept at working independently as well as collaboratively in a start-up environment. You’re a self starter who’s comfortable with multi-tasking and working with people at all levels. As part a small growing company, you must be highly effective and driven to meet objectives in an efficient and pragmatic manner.
As a Quality Assurance Specialist you will.
- Review executed batch records, specifications, and SOPs
- Conduct QA on the floor duties including but not limited to: line clearance, real time documentation reviews, spot audits
- Perform QA review and disposition of incoming raw materials
- Participate on various projects and support activities associated with manufacturing, testing and release of product
- Partner with Manufacturing, Process Development, Analytical Chemistry, Facilities, to meet clinical project and product needs
- Support activities related to qualification/validation of equipment and processes
- Revise quality systems procedures as required to maintain state of compliance with cGMP regulations
- Support training events related to quality procedures, cGMP regulations and guidelines
- Participate in internal audits
- Perform other QA responsibilities as assigned by management
Requirements
- Requires a bachelor's degree in a scientific discipline
- Minimum of 5 years of experience in a biotech, pharmaceutical, or medical device QA GMP function
- Strong working knowledge of cGMP regulations (e.g., 21CFR 4, 211, 820), ISO13485 and ICH guidelines
- Excellent verbal and written communication skills
- Strong computer skills
- Legally authorized to work in the US
Preferred:
- Experience in GMP for aseptic products in clinical studies (phase I - III) to commercial
- Experience with combination products a plus
Benefits
- Work in a collaborative, learning environment with cutting edge technology, research and development
- Flexible scheduling and generous perks
- Medical, Dental, Vision coverage
- 401k