Quality Assurance Specialist

Job Description

Job Summary:

• This role is responsible for executing Quality function deliverables to support Contract Manufacturing Organizations (CMOs) involved in the production of drug substance in support of rapidly growing Clinical and Commercial Programs.
• This position will manage QA tasks such as deviations, change controls, and investigations involved in production of drug substance.
• In this role, the person will be responsible for internal QA review and approval of documentation required to support batch manufacturing and disposition.
• The QA Specialist role ensures that establishes standards and practices and maintains documented procedures and instructions to satisfy cGMPs and Good Documentation Practices for all clinical and commercial drug disposition activities.
• This individual will work closely with Quality Assurance, External Manufacturing, Quality Control, Process Sciences and Regulatory teams.

Duties and Responsibilities:

• Ensure product quality at drug substance contract manufacturing operations, while developing and maintaining relationships.
• Perform functions and make decisions consistent with cGMPs, GDPs and quality governance.
• Provide QA support for the transfer of manufacturing processes and analytical methods for products to CMOs.
• Independent review and approval of change controls, deviations, OOS, CAPA, and metrics.
• Gather and provide metric information.
• Perform Batch Disposition in accordance with all applicable SOPs.
• Review and approval of Master Batch Records and executed Batch Records.
• Support SOP generation and revisions.
• Review of Protocols, Reports, Stability data and associated reports as needed.
• Support of Process performance qualification (PPQ) activities, including review of relevant validation protocols and reports.
• Support and preparation for company and Agency Inspections conducted at our CMOs, as needed.
• Maintain 100% training compliance.
• Additional duties as assigned.

Qualifications:

• A minimum of bachelor’s degree in sciences or engineering.
• A minimum of 3 years of QA operations experience in a GMP manufacturing facility.
• Excellent understanding of FDA, EMA regulations and ICH guidelines.
• Excellent organizational, communication, and interpersonal skills.
• Experience with electronic Quality Management Systems (experience with Veeva is a plus).
• Experience with electronic enterprise resource planning systems (experience in SAP is a plus.

Schedule Notes:

• This hybrid role is expected to support Monday – Friday during the hours of 8am to 4pm.
• Expected to be on-site in Cambridge, MA location, three (3) days per week with Thursday being a required on-site day.
• The remining 2 on-site days can be discretionary.