Quality Assurance Professional

6 days ago


Cambridge, Massachusetts, United States Voyager Therapeutics Full time
Join Our Team

Voyager Therapeutics is a rapidly growing biotech company looking for a Quality Assurance Specialist to join our team. This is an exciting opportunity to be part of a dynamic organization that is making a difference in the field of gene therapy.

The successful candidate will have a strong background in quality assurance and compliance, with a focus on GMPs. You will work closely with our Director, Quality Assurance to ensure company goals and objectives are met and compliance risks are identified and communicated to senior management.

The Quality Assurance Specialist will be responsible for conducting GMP compliance audits, reviewing and approving policies and SOPs, and participating in the development of technical quality agreements. The ideal candidate will have excellent communication and interpersonal skills, with the ability to work effectively in a team environment.

Responsibilities
  • Conduct and maintain New Employee Quality Orientation and Quality Refresher Training.
  • Develop and contribute to Policies and SOPs in support of the Quality Systems Manual.
  • Review and approve Policies and SOPs authored and developed by other functional areas.
  • Primary reviewer of CMO Master Batch Records (MBRs) and executed batch records, and approve when delegated by the Director, Quality Assurance.
  • Assist Clinical Operations in the development of Clinical Protocols, Investigator Brochures, Pharmacy Manuals, and other clinical documents as requested and directed.
  • Participate with Manufacturing Sciences and Clinical Operations in investigations of deviations ensuring the development of Corrective Actions and Preventative Actions (CAPA), as necessary.
  • Review and approve Technical Transfer Documents and CMO Protocols and Reports.
  • Conduct and support GMP audits of suppliers and CMOs. Assist in audits of Contract Research Organizations (CROs) and clinical sites, as necessary.
  • Participate in the company internal compliance audit program.
  • Participate in the development of Technical Quality Agreements for CMOs and CROs.
  • Represent Quality in various cross-functional Program Teams.
  • Support the preparation of Chemistry and Manufacturing Control (CMC) sections inclusive of data verification and audits.
  • Participate in the development of Regulatory Authority inspection strategies.
  • Assist in the development and implementation of Quality Metrics and overall Quality Compliance Strategy.
  • Maintain all associated tracking logs and files, as applicable.
Requirements

Estimated Salary: $110,000 - $150,000 per year.

A Bachelor's degree in chemistry, pharmacy, biochemistry or related discipline is required, with a minimum of 7 years QA GMP experience in a biotech/pharmaceutical environment. Excellent technical writing, attention to detail and problem-solving skills are essential.

Vacation time: competitive salary package.



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