Quality Specialist, Pharma DMS Document Control (v720)

  • Contract Duration: 6 months REMOTE, with potential to extend
  • Manufacturing
  • Boston, MA

Website Lenox Executive Search

Description

Lenox Executive Search is looking to hire a Quality Specialist for a contract position with one of our global pharmaceutical clients. This is a REMOTE position. This is a 6 month contract with possible extension. Document control experience is a MUST!

GENERAL RESPONSIBILITIES AND REQUIRED SKILLS of a Quality Specialist:

  • Presents a solid understanding of quality assurance concepts and practices
  • Demonstrates emerging knowledge of applicable regulations and the interpretation and application of regulations and compliance concepts
  • Exercises independent judgment to optimize some commonplace compliance procedures
  • Displays an emerging ability to manage client expectations
  • Displays effective communication skills (written and verbal), within their area(s) of expertise
  • Demonstrates proactive thinking and actions
  • Reviews and may be responsible for authoring SOPs and Work Instructions, with minimal supervision
  • May act as a representative of their Quality division on assigned project sub-teams and/or task forces
  • Demonstrates emerging skills in influencing others within project teams regarding quality or compliance concerns
  • Displays an emerging ability to develop innovative ideas for solving problems
  • Has the ability to read and respond to audiences appropriately
  • Performs other duties as assigned

KEY RESPONSIBILITIES of a Quality Specialist:

  • Dedicated DMS Document Control Representative
  • Independently manages the full life cycle of the Document Control processes including
  • QA Documents (SOPs, WIs, Forms, etc)
  • CMC Documents (Quality Standards, Analytical Methods, Specifications, Batch Records, etc.)
  • Document Distribution
  • 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
  • Attend weekly meetings
  • Conducts reviews of Quality and GxP SOPs, Work Instructions, forms and templates
  • Proactively identifies opportunities for process improvements in the Document Control program and works cross functionally to implement, as appropriate
  • Maintains user training materials for new users of the document control computer systems and business processes
  • Interacts with internal and external customers and functional groups at various management levels to provide customer service
  • May participate in regulatory inspections or due diligence activities, as requested
  • May participate as document control representative on internal and external cross functional projects driven sub-teams
  • Performs other duties as assigned

PREFERRED EDUCATION AND EXPERIENCE of a Quality Specialist:

  • B.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)
  • Proficient in Microsoft Office programs, technical writing skills
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– The Lenox Executive Search Team