A well-established contract research organization (CRO) that provides services to the pharmaceutical, biotech, medical device, and regenerative medicine industries specializing in research and testing for small molecules, large molecules, biologics, medical device, and cell and gene therapy is looking for a Quality Assurance Specialist to join the team at the new Woburn, MA facilities. The ideal candidate may perform initial review and preparation of records and events, but will not need to perform technical approvals, high level Quality decisions, or release of GxP material or documentation, unless specifically authorized in writing by the Quality Systems Manager. This is a 6 month contract-to-hire role with full benefits.
- Perform tasks to support ASB Quality Systems Manager in maintaining all key ASB Quality Systems.
- Review Standard Operating Procedures (SOPs), Validation and Sample Analysis Reports, as well as the individual data.
- Assign document change numbers, coordinate review and approval according to established document review matrices, and track document change events to completion.
- Review SOPs for administrative accuracy.
- 1-5 years of biotech, pharmaceutical or medical device industry experience.
- Highly detail oriented.
- Ability to work independently and on teams.
- Ability to take direction from, and work with multiple functions, at all levels of the organization.