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Senior QA Lead

3 weeks ago

Tarrytown, New York, United States RCM Life Sciences and IT Full time
About the Role

At RCM Life Sciences and IT, we are seeking a highly skilled Senior QA Specialist to join our team. This is an excellent opportunity for someone looking to grow their career in quality assurance and make a meaningful contribution to our organization.

The ideal candidate will have 7+ years of experience in IT, Computer Science, Engineering, or Chemistry in an FDA regulated manufacturing environment. They should possess a thorough understanding of IT CSV and QA IT roles and responsibilities in support of GxP compliance.

We offer a competitive salary range of $70-$90 per hour, commensurate with experience, and a comprehensive benefits package. Our company is an equal opportunity employer, committed to providing a fair and inclusive work environment for all employees.

Key Responsibilities
  • Ensure IT processes and procedures meet Quality System requirements.
  • Participate and support the Quality Risk Management (QRM) principles in formal and informal risk assessment initiatives.
  • Provide support and guidance with quality system records activities such as change controls, corrective and preventive action plans (CAPAs), risk assessments, data integrity initiatives, deviations, internal and external audits, standard operating procedure (SOPs), work instructions/job aids, policies, etc.
  • Collaborate with other functional areas to collect information and provide guidance through all stages of the quality management system and improvement projects.