Specialist/Senior Specialist, Quality Assurance
About The Position
Axsome Therapeutics is seeking a Quality Assurance Specialist/Senior Specialist to focus on ensuring compliance with Good Manufacturing Practices (GMP) with all work performed. The QA Specialist/Senior Specialist will provide the Quality Assurance team oversight of external manufacturing activities to ensure consistent compliance with company procedures, regulations, and industry expectations. This role is based at Axsome’s HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.
Requirements
- Bachelor’s degree required with a preference within a scientific discipline
- 2-5 years of relevant Quality Control or Quality Assurance experience in a GMP- regulated commercial environment
- Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles
- Proficient knowledge of GMP regulations and guidance documents
- Strong attention to detail
- Excellent interpersonal and communication skills (both written and verbal)
- Proven ability to multitask projects of varying complexity
Nice To Haves
- At least 1 year experience reviewing manufacturing batch records is preferred
- Experience working in Quality Assurance Operations with a strong focus on Batch Record Review and Shop Floor support
- Experience supporting clinical manufacturing operations is a plus
Responsibilities
- Review executed batch production records for completeness, GDP and ALCOA requirements
- Communicate and resolve discrepancies with third-party CMOs
- Perform release of all manufactured, packaged and tested materials (including but not limited to raw materials, intermediates and drug products)
- Ensure timely escalation to management of all applicable incidents
- Review test and stability data ensuring data accuracy, conformance to test procedures, specifications, and documentation standards
- Initiate and track quality events (deviations, change controls, CAPAs) in Axsome’s eQMS through closure
- Work collaboratively with internal departments to respond to and resolve deviations and OOSs
- Provide support in the review and approval of cGMP-controlled documents such as master batch records, test methods, and specifications
- Provide support in the review of change controls related to manufacturing, analytical test methods, and specifications to meet cGMP and internal standards
- Support the annual product review process
- Provide QA support for process validations including reviewing protocols and reports
- Contribute to the refinement and ongoing improvement of manufacturing processes and documentation at various CMO locations
- Write and review Standard Operating Procedures, as needed
- Support the development, implementation, and improvement of corporate quality management systems that support late phase clinical and commercial programs.
- Support regulatory agency inspections as needed
- Support the development and reporting of site Quality Metrics
Benefits
- Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
251-500 employees
