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Quality Assurance Compliance Specialist AP13567823

ADPI LLC New Haven, CT

  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Quality Assurance Compliance Specialist AP13567823

New Haven, CT 

12 Month Contract 

Will be located onsite at New Haven site. Candidate will be needed onsite at least 2x per week, sometimes more and sometimes less depending on what is going on - The other days they will be allowed to work remote.

 

This role will be the primary point of contact for handling physical archives, lab notebooks/logbooks, and pulling records during audits.

Skills: 

  • 3-5 Years of Experience working in a Quality Assurance, Quality Systems, or related role.
  • Knowledge of GXP Records and Archiving compliance.
  • Excellent organization-skills and attention to detail. Preferred experience with archiving, categorizing, and organizing physical records and document management.
  • Skilled in using Excel and Quality software to run reports and organize data.
  • Superb communication skills and ability to work with multiple customers both in-person and remote.

Education: Bachelors Degree in Scientific, Business, or related field or equivalent demonstrated experience.

Duties: 

  • Serve as the primary Point-Of-Contact for on-site GXP Records / Archiving at the New Haven, CT site.
  • Receive and respond to Documentation Services inquiries from various functions
  • Perform Coordination for document changes in the Electronic Document Management System (eDMS).
  • Manage GXP Archives at the New Haven, CT site which includes receiving and logging archive requests, retrieving Records from internal customers, and coordinating with Records vendor/supplier to retrieve and archive records.
  • Manage the Enterprise Archiving & Retention business-process and associated processes taking direction from the Senior Manager, Documentation Services.
  • Manage the New Haven Lab Notebook/Logbook processes in collaboration with the Analytical and BioAnalytical Sciences labs onsite in New Haven, CT.
  • Work with internal customers to track and report on SOP Master lists for Clinical studies and GXP audits.
Company Description
ADPI, LLC Premier IT Staffing Company dealing with LARGE Direct Clients Only.

ADPI LLC

ADPI, LLC Premier IT Staffing Company dealing with LARGE Direct Clients Only.

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Address

New Haven, CT
USA

Industry

Technology

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