Sr. Specialist, Quality Assurance

Boston, MA

Description:

The Senior Specialist will assist in leading the GXP quality program by providing support for assuring current Good Manufacturing Practice (CGMP), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) compliance with all regulatory statutes including state, federal, and international regulations, and company policies that govern the development of drugs, biologicals and other company products. The main focus of this role is to support GMP activities but experience in GCP and GLP is a plus. In addition, the incumbent will be responsible for assisting in the development and maintenance of the company’s Quality Systems, including preparation and maintenance of Standard Operating Procedures (SOPs), the internal training program, internal and external auditing program, review and approval of batch-related documentation, Quality Event review and disposition, process validation and establishment and maintenance of the QA files. The Senior Specialist may also participate in the development and generation of regulatory submissions to governmental agencies worldwide, as required.

Essential Function & Duties:

  • Work with cross functional departments and external partners and vendors on CMC related activities or functions. Manage the Quality Event System and documentation related to but limited to change control, CAPA, deviations and investigations as it related to GMP.
  • Work with QA clinical supply function and Technical Operations to maintain acceptable CMC material/inventory in support of clinical development programs. Verify that drug substance and drug product are manufactured according to CGMPs and perform review of CMC related documentation and the release of drug substance, drug product and finished drug product (labeled CTM).
  • Manage the GMP vendor and vendor audit program in conjunction with our CMC partner and perform vendor audits as required.
  • Assure that activities conducted on behalf of the company are in compliance with applicable laws, regulations and company policies by conducting audits of vendors, including manufacturers, contract labs and nonclinical and clinical research sites.
  • Oversight of Stability Program and associated activities such as expiry and shelf life determination. Audit regulatory submissions to assure accuracy
  • Report findings and risk assessment of deficiencies and deviations from company standards to the head of Quality.

Skills:

  • The ability to analyze data, determine root cause of deficiencies, and provide recommendations for resolution.
  • Demonstrated ability to independently review manufacturing and testing records, review and approval of batch-related documentation, and disposition of clinical trial material. Work with Partners to resolve any CMC related issues.
  • Manage the Quality Event System and documentation related to but not limited to change control, CAPA, deviations and investigations.
  • Ability to manage and/or support the document management system, and maintenance of quality-related files
  • Demonstrated ability to manage the quality aspects of process and analytical method validation and/or process and method transfer activities.
  • Excellent communication skills, both verbal and written, including appropriate use of medical and scientific terminology
  • Excellent interpersonal skills.
  • The ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events
  • Understand the drug and biologic development process, clinical research process including medical & clinical terminology, non-clinical research process including terminology, manufacturing processes including terminology
  • Knowledge and experience using EDM Systems is a plus.

Education & Experience:

  • Bachelor’s degree (BA/BS) in a scientific discipline, and a minimum of 3 to 5 years’ experience in quality assurance, or equivalent appropriate experience. A broad understanding of the drug development process is required.

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