Quality Assurance Specialist II

BioTime, Inc., a pioneer in regenerative medicine, is a clinical-stage biotechnology company.  BioTIme and its subsidiaries are leveraging industry-leading experience in pluripotent stem cell technology and a broad intellectual property portfolio to facilitate the development and use of cell-based therapies and gene marker-based molecular diagnostics for major diseases and degenerative conditions for which there presently are no cures.  Its broad platform of stem cell technologies is developed through subsidiaries focused on specific fields of applications. BioTime is pursuing a CE Mark approval for Renevia™cell delivery device in the EU.  In order to support an effective ISO 13485 compliant quality system and GMP manufacturing of the Renevia™ device at contract manufacturing organizations, BioTime is hiring a Quality Assurance Specialist.

POSITION

  • Perform daily document control activities, including but not limited to:
    • Generating, issuing, tracking, scanning, and filing controlled documents used in development, clinical, regulatory, Quality Assurance, and operations
    • Document word processing and formatting
    • Document review for accuracy and consistency
    • Document change request initiation, processing, and timely completion
    • Maintaining the company’s document control system and physical records
    • Communicating document status company wide
  • Perform activities pertaining to external contract manufacturing organization (CMO)’s documentation:
    • Processing external documents for BioTime review and approval
    • Communicating with CMO on the status of document approval
    • Interfacing with CMO to address documentation issues
    • Receiving and filing CMO manufacturing and test records
  • Contribute to the maintenance and improvement of company’s Quality System
  • Contribute to company’s training program and maintenance of training records
  • Contribute to compilation and maintenance of product design history files
  • Assist in preparation for supplier audits and maintaining supplier management files
  • Assist in preparation for regulatory inspections and regulatory submissions
  • Support in-house research and development process work such as processing R&D documents and forms, assigning R&D process work part numbers & lot numbers
  • Perform other duties as assigned

QUALIFICATIONS

  • BS degree in related scientific field with 1 to 3 years of experience in a GMP regulated biotechnology, pharmaceutical, or medical device organization with experience in Document Control / Quality Assurance
  • Attention-to-detail is a must as is the ability to perform work accurately.
  • Excellent computer and word processing skills
  • Strong organizational and interpersonal skills
  • Ability and willingness to be compliant with procedures and regulations
  • Ability to be a team player with a collaborative approach and comfortable working in a dynamic and fast paced environment

Benefits and Compensation:

  • Health and Dental insurance fully paid by the company for employee and dependents
  • Eligible to participate in company’s 401k plan and up to 5% ER match with no waiting period
  • 15 PTO days and 10 Holidays annually
  • BTX stock options