Quality Assurance Specialist II - Materials

Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.

The Quality Assurance Specialist II will provide QA oversight of the development, planning, implementation, and maintenance of the materials supporting all Cook Myosite processes to ensure procedural and external regulatory requirement compliance.

• Understand, interpret, and apply regulatory requirements pertaining to materials use in support of production of a cell therapy product, in a FDA-regulated environment
• Function as a quality subject matter expert in the use of materials supporting processes and methods as a quality representative on project teams
• Review and approval of material related quality documents including validation documents, stability program documentation, retention and storage documents/Specs
• Review and approval of reports for critical control points, critical quality attributes, the stability program, retention, storage, etc., within the organization to ensure the material is managed, and qualified/validated in a compliant manner
• Facilitate authoring of investigations, especially those pertaining to material deviations, and assist in identification of appropriate CAPAs to address problems
• Perform review and approval processes for investigations for both CAPA implementations and closure activities related to material
• Review and approval of material related change controls/requests, SOPs, and forms to ensure that test methods are performed in a compliant manner and meet their intended purpose
• Author Quality System documents
• Participates in risk assessment processes
• Review and approve prepared material, and cell therapy intermediate and final product batch records and associated records and disposition accordingly
• Perform additional activities related to overall Quality Assurance as requested by management, e.g. audits, vendor qualifications
• Promote GLP/cGMP environment and follows procedural guidelines

• Bachelor's degree in any life science, related engineering field and 1-3 years’ experience in pharmaceutical/biopharmaceutical industry or 6 years direct, relevant experience in pharmaceutical/biopharmaceutical quality assurance to provide a comparable background

• Minimum of 1-3 years' experience in applying GMP requirements and sufficient biology/biochemistry to understand the methodology associated with manufacturing a cell therapy product in an FDA-regulated environment

• Project Management skills preferred

• Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing
• Proficient knowledge of Microsoft Office software, and other general office equipment
• Ability to learn and support new systems and applications, and the ability to provide technical training to end users

Physical Requirements:

• Laboratory Setting (Non-Production: General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II

• Ability to conduct and hear ordinary conversation and telephone communication
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required
• Ability to work under specific time constraints
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time
• Visual and manual acuity for working with computers and equipment
• Ability to spend majority of day standing in laboratory setting or sitting in biological safety hood setting
• Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations
• Must be able to lift/push/pull up to 50 pounds on an occasional basis with or without reasonable accommodations
• Must be capable of performing PPE gowning procedures on a frequent basis to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and facial mask (if required) on a regular basis
• Must be able to extend arms outright for extended periods of time, periodically at intervals for up to 3 hours at a time