QA Consultant

at  Raland Compliance Partners

Functions as a technology and process subject matter expert.

• Provides on-the-floor and on-site technical support to manufacturing when necessary.
• Author, review and approve, as needed, various documents (eg. Batch records, SOPs).
• Author, and approve protocol and reports in accordance with internal and external regulatory expectations (APS, Engineering, Tech Transfer).
• Analyze and summarize manufacturing data to support impact assessments and investigations.
• Owner of change controls for process and procedure changes.
• Lead and executes CAPA system investigations.
• Leads technology transfer efforts for new processes and product implementation.
• Performs tech transfer facility fitness, gap analysis, and risk assessment when on-boarding new programs.
• Applies continuous improvement tools to identify and close procedural and compliance gaps
• Identify opportunities for process improvements and operational efficiencies, and lead implementation efforts.
• Represent MSAT and interface with other functions such as Process Development, Supply Chain, Quality, Validation, and Facilities & Engineering.
• Support equipment and systems validation activities, including review of equipment qualification documents, drafting user requirement specifications, and participating on impact assessments.
• Ability to perform gowning activities and enter the manufacturing plant.
• Some travel will be required.

Education or Equivalent Requirements:

• BSc and/or Advanced degree in Science or Chem/Bio Engineering
• Minimum 5 years of industry experience.
• Minimum 3 years relevant experience in GMP biologic/cell therapy manufacturing technical or process support.
• Advanced degree(s) preferred

Knowledge/Skills Requirements:

• Scientific understanding in bioprocessing principles. Familiarity with cell therapy processes and cGMP is strongly preferred.
• Experience in Process qualification, validation
• Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities is a huge plus
• Experience with program management software and tools are a plus
• Experience working with external parties and/or cross-functional teams
• Experience interfacing with clients
• Possess strong verbal/written communication skills and ability to influence at all levels
• Ability to think strategically and to translate strategy into actions
• Ability to prioritize tasks in a highly dynamic environment

Please refer the Job description for details