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Senior Scientist - QC laboratories
Ref No.: 18-03165
Location: Lexington, Massachusetts
Job Title: Senior Scientist - QC laboratories
Location: 300 Shire Way, Lexington, MA 02421
Duration: 9 Months

  • Lead or support the execution, and data analysis of assay validation, method transfer(co-qualification) studies in the QC laboratories. Support completion of all protocols and validations in a timely and appropriate manner.
  • Contribute to the evaluation of new methodologies and transfers to determine business need and applicability to the area.
  • Perform evaluations/testing as related to improvements or project.
  • Provide recommendations for or implement instrumentation upgrades or improvements to drive optimal performance.
  • Author or support the writing of technical memos, reports, protocols, studies and other appropriate documentation to support laboratory validations, investigations and/or objectives.
  • Frequent use and general knowledge of industry practices, techniques, and standards. Provide technical support to the QC Laboratories.
  • Support global standards/strategies in continuous improvements.
  • Comply with control of lab documentation.
  • Review data with application of good documentation practices.
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, QSR, and cGMP regulations.
  • Assure compliance with company procedures, quality and regulatory requirements, and regulatory guidance documents including QSR, cGMP, USP, CFR, and compendia literature.
  • Support and implement laboratory systems and/or guidelines to meet compliance requirements.
  • Support regulatory and non-regulatory audits (e.g. Internal Quality Assessment, Corporate, FDA, etc).
  • Support regulatory submissions /change control requests in a timely manner when required.
  • Proactively an actively contribute to a team setting to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.
  • Support technical presentations and/or training to QC Laboratories (including management) as needed.
  • Ensure personal training requirements are met and training records are current.
  • Stay current in the technical and compliance field regarding lab instruments and methods.
  • Perform Disposal of Hazardous Waste as required.