FMD K&L

Senior Quality Assurance (QA) Analyst

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Posted On:
Closing On:
Thursday, 5th March 2020
Tuesday, 5th May 2020
Job Type:
Pharma Consulting
Duration:
Travel:

Job Description:

Please contact tony.roig@klserv.com for more information.

FMD K&L is a global contract research organization supporting data management, biostatistics, statistical programming, clinical operations, regulatory affairs, safety, pharmacovigilance, toxicology, medical affairs, medical writing, quality, risk, and compliance services to the pharmaceutical, biotechnology, and medical device industries worldwide. We continuously strive to raise the standard of excellence through accuracy and efficiency to achieve the highest quality output for our Customers. K&L was established in the US in 1995, and has grown to more than 1,700 employees worldwide, with key offices and delivery centers in the US, UK, China, India, Armenia, Japan and throughout the Asia-Pacific region.

Our Quality team is looking for a Sr. Quality Assurance Analyst to support activities related to developing and implementing standard operating procedures (SOPs), leading internal or Computer System Validation projects as needed, conducting internal and external audits, and creating/reviewing internal documentation and reports. This position is also responsible to ensure that quality standards are met throughout the Company. This position includes, but is not limited to:
  • Create, review, and update Standard Operating Procedures, Forms, and other controlled documents.
  • Coordinate activities involving quality assurance and compliance with applicable regulatory requirements.
  • Host client, internal, and agency audits as applicable
  • Provide QA trending analysis and metrics reports to the management team.
  • Ensure that applicable computerized systems remain in a validated state and in compliant with company’s SOPs.
  • Lead internal process improvement initiatives.
  • Lead and coordinate Computer System Validation (CSV) projects.
  • Create, review, and update validation documents (Validation Plan, IQ/OQ/PQ, Trace Matrix, Validation Report, & etc) as applicable and assist in providing consultation to the project team as needed.
  • Review and approve internal computerized system change controls to ensure meeting the internal requirements and SOPs.
  • Other job duties as assigned by management.

Preferred Skills:

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