Quality Assurance Specialist

The Quality Assurance Specialist will actively contribute to the implementation and maintenance of the Quality Systems Manual and conduct GMP compliance audits as directed. The QA Specialist will have oversight of and involvement in, GMP compliance for production of Clinical Trial Material (CTM), including work performed by Contract Manufacturing Organizations (CMOs). Provide assistance in the audit and oversight of Contract Research Organizations (CROs) as directed. The incumbent will work closely with the Director, Quality Assurance to ensure company goals and objectives are met and compliance risks are identified and communicated to senior management. This position is located in Cambridge, MA.

Key Responsibilities:

• Conduct and maintain New Employee Quality Orientation and Quality Refresher Training with primary responsibility for the Training System including documentation.
• 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
• Effectively communicate progress and issue resolution to the Director, Quality Assurance and key stakeholder of the Program Teams.

Skills & Requirements

Qualifications and Experience:

• BS in chemistry, pharmacy, biochemistry or related discipline
• Minimum 7 years QA GMP experience in biotech/pharmaceutical environment required. GCP and GLP experience a plus.
• Demonstrated knowledge and understanding of quality compliance principles with specific focus on GMPs (CRO compliance knowledge a plus).

Additional Experience Desired:

• Biological Drug Substance production
• Production of Injectable Products
• Performance of GMP compliance audits (suppliers, CMOs, etc.)
• Oversight and interactions with CMOs (CROs desirable)
• Excellent technical writing, attention to detail and problem-solving skills

Domestic travel required (approximately 20%)