Senior QA Specialist, Quality Document Management

Cambridge, MA, United States
Jun 30, 2020
Required Education
Bachelors Degree
Position Type
Full time
Senior QA Specialist, Quality Document Management

This is a full-time position located in Cambridge, MA in the Quality Systems & Compliance Department.

This position is responsible for the development, improvement, and maintenance of CRISPR Quality Document Management System in compliance with Health Agencies regulations and company policies and procedures. This position reports to the Head of Quality Systems & Compliance.

Primary Duties and Responsibilities:
  • Develop & maintain procedures to ensure that Quality System documents are originated, revised, reviewed, distributed, and meet all regulatory requirements.
  • Develop and administer the EDMS (Veeva QualityDocs)
  • Develop and maintain archival systems for all records assigned to the Document Control department.
  • Support cross-functional teams in processing documentation requests and document approval.
  • Ensure the harmonization of Document Control systems across all sites.
  • Develop and maintain databases or other computerized systems that improve document/records control systems.
  • Prepare periodic summaries or trend analyses of document and record control activities.
  • Train employees on use of Document Control System.
  • Coordinate periodic reviews of documents
  • Review controlled documents and records to ensure proper formatting.
  • Maintain expert knowledge of regulations involving document and records control.
  • Develop and maintain systems for issuance of critical product labels including package inserts, packaging artwork, etc.
  • Work with functional areas leads to develop and revise templates for controlled documents and records.
  • Support audits and inspections of the CRISPR Quality Management System.

Education and Experience Requirements:
  • A minimum of five (5) years direct document control experience in a pharmaceutical, medical device or biotechnology company.
  • B.S. degree in Life Sciences preferred.
  • Extensive knowledge of US, EU and other International Compliance Regulations and industry practices pertaining to Document Management.
  • Knowledge and experience in use of Part 11 Compliant validated computer systems.
  • Excellent attention to detail, time management, organization skills, and able to manage multiple priorities with aggressive timelines.

CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

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