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Material Handler

Akebia Therapeutics

Material Handler

Cambridge, MA
Paid
  • Responsibilities

    The Sr. Quality Assurance Compliance Specialist QA Operations is primarily responsible for providing appropriate oversight to ensure cGMP compliance of Commercial Materials and Clinical Trial Material (CTM) and Contract Manufacturing Organizations (CMOs).  The position will work in collaboration with the QA leads, CMC and Regulatory to provide QA oversight to Chemistry, Manufacturing, and Controls department to develop and implement programs for appropriate regulatory cGMP compliance.

    Required Skills

    • Review and approve CMO Master Batch Records (MBRs) and Executed Batch Records (EBRs) to support the commercial and clinical programs at Akebia
    • Review cold chain and temperature excursions related to investigational products
    • Support internal and external cGMP audit plans for Akebia development programs.
    • Regulatory Inspection preparation–support CMOs and Akebia internal preparation in the overall regulatory inspection management (pre-approval inspections, general GMP inspections) covering inspection preparations, execution of regulatory inspections, preparation of responses to health authorities and inspection follow-up.
    • In cooperation with CMOs and other functions within Akebia, support the CMOs in devising and executing remediation actions to ensure compliance to regulatory and Akebia expectations and requirements. Approve CAPAs and regularly review progress and continue to give ongoing support in all compliance matters.  Organizing internal investigations and assure complete and accurate documentation.
    • Provide guidance, advice, and support for GMP Quality Compliance matters. As a member of the CMC team, participate in the agreed projects and activities designed to support Quality aspects of CMC objectives within Akebia.
    • Quality Metrics – participate in metrics, reporting, reviewing, and trending of cGMP-related Quality Key Performance Indicators (KPIs) in support of the QMS.
    • Perform data audits of CMC documentation intended for submission to regulatory health authorities (e.g., FDA, EMA).
    • Maintain associated tracking logs, audit files, as applicable.
    • Assist in development and implementation of pre-approval inspection readiness plans and assist senior staff during regulatory inspections.
    • Domestic and international overnight travel is required

    Required Experience

     

    Basic Qualifications: 

    • BS in chemistry, pharmacy, biochemistry, biology, or related discipline 
    • Minimum 5 years of QA experience in the biotech/pharmaceutical environment 
    • Experience in hosting GMP regulatory inspections desirable

    Preferred Qualifications:

    • Demonstrated strong understanding of US cGMPs and knowledge of EU GMPs
    • Experience in the following is highly desirable:
      • Chemical drug substance operations
      • Solid oral dosage form manufacturing
      • Investigational product distribution/supply chain logistics,
      • Experience with external CMO environments and as a part of a CMC team,
      • Technology transfer, scale-up and late phase clinical development, commercial GMP drug release
    • Excellent technical report writing skills
    • Strong Communication, interpersonal and problem-solving skills and detail oriented

     

    Akebia Therapeutics is an equal opportunity employer and welcomes all job applicants.  All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

     

  • Qualifications
    • Review and approve CMO Master Batch Records (MBRs) and Executed Batch Records (EBRs) to support the commercial and clinical programs at Akebia
    • Review cold chain and temperature excursions related to investigational products
    • Support internal and external cGMP audit plans for Akebia development programs.
    • Regulatory Inspection preparation–support CMOs and Akebia internal preparation in the overall regulatory inspection management (pre-approval inspections, general GMP inspections) covering inspection preparations, execution of regulatory inspections, preparation of responses to health authorities and inspection follow-up.
    • In cooperation with CMOs and other functions within Akebia, support the CMOs in devising and executing remediation actions to ensure compliance to regulatory and Akebia expectations and requirements. Approve CAPAs and regularly review progress and continue to give ongoing support in all compliance matters.  Organizing internal investigations and assure complete and accurate documentation.
    • Provide guidance, advice, and support for GMP Quality Compliance matters. As a member of the CMC team, participate in the agreed projects and activities designed to support Quality aspects of CMC objectives within Akebia.
    • Quality Metrics – participate in metrics, reporting, reviewing, and trending of cGMP-related Quality Key Performance Indicators (KPIs) in support of the QMS.
    • Perform data audits of CMC documentation intended for submission to regulatory health authorities (e.g., FDA, EMA).
    • Maintain associated tracking logs, audit files, as applicable.
    • Assist in development and implementation of pre-approval inspection readiness plans and assist senior staff during regulatory inspections.
    • Domestic and international overnight travel is required
  • Industry
    Transportation / Trucking / Railroad