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Sr audit operations specialist
2 months ago
Sr Audit Operations Specialist (REMOTE)
OBJECTIVES/PURPOSE/DELIVERABLES:
The QA Research Data Assessment Associate, a member of the Research Quality Assurance organization, will be responsible for identifying, mapping and conducting in-house laboratory assessments globally across R&D to create a comprehensive mapping of in-house laboratory activities. Assess non-GxP as well as GxP laboratories for basic good research practices activities across R&D functions, (as applicable).
Developing this comprehensive assessment and mapping of all the R&D in-house laboratories will aid the R&D organization with assessing any compliance gaps and areas for process improvements. This research laboratory mapping and assessment process will include identifying the laboratory locations, laboratory walkthroughs, completing assessment tools, generating an assessment summary report identifying areas of concern and potential compliance gaps.
Under the direction of the Research Quality Assurance Lead, the person assuming this role will be expected to work with cross functional stakeholders in R&D Laboratory Operations, Scientist, Technicians, and laboratory managers, R&D functional area personnel responsible for in-house laboratory operations/activities.
The QA Research Data Assessment Associate will be an expert identify, map, and conduct in-house laboratory assessment/audits, generate a laboratory assessment report for each laboratory and a final comprehensive summary report of all laboratories identify areas of concern and potential compliance gaps. The QA Research Data Assessment Associate should have at least 5 years’ experience GLP, Part 11, Research Laboratory, Analytical laboratory experience as a GLP auditor, exceptional interpersonal skills, and highly organized and detailed, ability to assess non-GxP areas to good research practices standards to ensure all assessments are completed in a timely (and compliant) manner.
EDUCATION/COMPENTENCIES/SKILLS:
· Experience performing GLP audits, understanding laboratory operations.
· Attention to detail in performing laboratory assessment tasks.
· Experience in using Microsoft Offices products including, Word, Excel and PowerPoint.
· Excellent organizational skills and the ability to handle multiple priorities and projects.
· Strong organizational and communication skills
· Strong written and verbal communication skills
EXPERIENCE:
· Research laboratory experience, auditing experience in GLP or GCLP, Part 11, Analytical/Bioanalytical, Toxicology environments
· Strong understanding of good research practices and data integrity
· Organized, detail-orientated, and a self-starter
· Ability to understand and apply “fit for purpose” auditing assessments
· On-site to conduct laboratory assessments otherwise remote is acceptable
LOCATION & TRAVEL
Home Based, Up to 10% Travel including overnight and international locations
START & TERM
ASAP, Multi-Year Ongoing Role
RATE/SALARY/BONUS/BENEFITS
Competitive
