Quality Disposition and Investigations Specialist

QUALITY DISPOSITION AND INVESTIGATIONS SPECIALISTDEVENS, MA Candidate will be remote until COVID restrictions are lifted, and the site is reopened. MUST HAVE:

• Candidate MUST HAVE exp in and worked directly with SAP/Electronic Applications.
• Demonstrated proficiency in common computer tools such as word processing, spreadsheet, and web-based applications, as well as ERP solutions such as SAP.

• Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, related discipline, or its equivalent.
• Experience in a laboratory, manufacturing, quality, or warehouse environment desired.
• Ideal candidate is recommended to have a minimum of 2 years of directly relevant experience in a regulated environment.
• Prior evidence of successful participation on work/study teams where combined contribution, collaboration, and time bound results are expected.
• Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web-based applications, as well as ERP solutions such as SAP.
• Work/study experience where attention to detail and personal accountability were critical to success.
• Previous work experience where attention to detail and personal accountability were critical to success.
• Strong communication skills and the ability to follow written and verbal instructions.

• Assist in the startup of the Devens Cell Therapy facility, including:
  • Review of Standards, Procedures, Work Instructions, and Training modules.
  • Establishing new procedures.
  • Establishing business processes to monitor and track routine workload.
• Compile and/or review of disposition deliverables for incoming materials and finished Drug Product.
• GMP inspection and release of incoming consumables, raw materials, and other starting materials.
• Execute inventory and material master transactions in electronic systems such as SAP and Syncade (Manufacturing Execution System).
• Perform quality review of deviations, CAPA, Effectiveness Reviews, and other quality system records in electronic systems (Veeva).
• Coordinate with global and other cell therapy site functions for alignment
• Other responsibilities as needed.

• Work in a cGMP manufacturing environment following techniques which require one to maintain a high attention to detail.
• Properly use Personal Protective Equipment (PPE), gowning for restricted areas, and work in a general office environment.

• Receive general instructions on routine work and detailed instructions on new assignments.
• No supervision responsibilities exercised.