Summary:
An innovative and growing biotech company in Emeryville specializing in the development of disposable health diagnostic hardware is urgently looking for a Sr. Document Control professional. The Sr. Document Control will be responsible for maintaining document control and archive functions, facilitate processes for change control, training systems, and quality metrics reports. This is a 6 month to hire position.
Responsibilities:
- Maintain GMP compliant document control functions and facilitate appropriate processes, practices, and procedures.
- Maintain and improve processes associated with an electronic document control/training system.
- Facilitate and maintain the process of creating, reviewing, approving and archiving of SOPs, Work Instructions, etc.
- Ensure current versions of controlled GMP documents are readily available.
- Responsible for Document Control and maintenance of quality records of both electronic and hardcopy files.
- Create and maintain monthly quality metrics reports including change control and training.
- QA system support during internal and external inspections.
Requirements:
- Bachelor's degree in a scientific discipline preferred.
- Experience in a GMP regulated environment.
- 3 - 6 years of experience in a professional workplace environment.
- Strong organizational and communication skills.
Competitive wage, full benefits, and excellent chance to grow within an innovative company in biotech.
