03 Jul
Contract - Quality Senior Specialist
Massachusetts, Boston , 02108 Boston USA

Title: Contract - Quality Senior Specialist

Location: Boston - 100% Onsite

Duration: 6+ Month contract

About the Company: A global pharmaceutical company

Benefits: Real Staffing offers medical, dental, vision, 401K, voluntary life insurance, short term/long term disability.

Your Main Responsibilities:
  • Recognized as a technical resource within their discipline; answering questions and requests related to the DMS (CMC, QA, System Downtime, etc) and incidents and service requests
  • DMS Business Owner responsibilities
  • Maintain GXP archives, including receipt, processing and storage of GXP records.

  • Facilitate the lifecycle of controlled documents in the electronic document management system (document creation, revision, issuance, and obsolescence)
  • CMC Documents (Master Batch Records, Analytical Methods, Specifications, etc.)
  • QA Controlled Documents (Standard Operating Procedures, Work Instructions, etc.)
  • Document Distribution (including batch record and logbook issuance)
  • Interacts with internal and external customers and functional groups at various management levels to provide excellent customer service

Basic Qualifications:
  • S. in a scientific or allied health field (or equivalent degree) and 3 - 5 years of relevant work experience, or
  • Relevant comparable background
  • Experience working in Electronic Document Management Systems (Doc Compliance, Veeva, Documentum, etc)
  • Presents a solid understanding of quality assurance concepts and practices
  • Demonstrates knowledge of applicable regulations and the interpretation and application of regulations and compliance concepts related to document control
  • Responsible for all GxP Archiving Activities and regulatory knowledge

  • Presents a solid understanding of both digital and paper document control best practices
  • Exercises independent judgment to optimize compliance procedures and identify opportunities for continuous improvement
  • Able to manage and anticipate client expectations

  • Displays effective communication skills (written and verbal), within their area(s) of expertise
    Responsible for reviewing and authoring SOPs and Work Instructions, with minimal supervision
  • Acts as a representative of their Quality division on assigned project sub-teams and/or task forces
  • Demonstrates proficiency in influencing others within project teams regarding quality or compliance concerns

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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