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.
Opportunity
This position plays a major role in the company’s compliance systems. Responsible for administration of the document control department and compliance systems. This position reports to the Senior Director of Quality.
Responsibilities
The Document Control Manager is responsible for administration of documents in our electronic documentation system (Master Control) as well as the current paper systems. The Document Control Manager will be responsible for the implementation of electronic compliance systems for current the paper systems (CAPA, Change Control, Deviation, Complaints, and Training) and the administration of these systems. Drive efforts for continuous improvements by identifying ways to improve quality, throughput, and compliance. Work in an FDA regulated environment and support the company in meeting quality compliance requirements.
Facilitate the process of creating, reviewing, approving and archiving, SOP’s, WI’s, forms, specifications, batch records, and other quality documentation. Create document templates. Maintain training records and integrate training requirements into Master Control. Train staff on Document Control procedures. Create and update Document Control procedures. Maintain and manage paper systems. Assist in the implementation electronic quality system modules. Archive CMO and Suppler documentation. Facilitate the traceability of documents provided to suppliers and CMO’s. Issue and control laboratory notebooks. Prepare and present metrics for Management Review. Support internal, external, and regulatory audits. Be excited about making an immediate impact within the company!
Requirements
Bachelor’s degree in a life science or equivalent Experience using electronic compliance systems, Master Control experience preferred Minimum of 5 years related work experience, with a minimum 2 years as Supervisor or Manager Organized and detail oriented Curious and interested in learning new things Effective working independently or as part of a team Collaborative, flexible, and driven Working knowledge of scientific principles Excellent computer skills, MS Office proficiency Legally authorized to work in the US
Benefits
Work in a collaborative, learning environment with cutting edge technology, research and development Flexible scheduling and generous perks Medical, Dental, Vision coverage 401K