Regulatory Compliance Specialist

4 weeks ago


Indianapolis, Indiana, United States Randstad Full time

We are seeking a highly skilled Regulatory Compliance Specialist to support our client's global quality assurance policies and compliance.

This is a primarily remote position, but you must be able to commute to our Indianapolis office for audits.

This is a Temp To Hire opportunity.

Requirements:

  • 6 years of experience in a regulatory environment, preferably in GXP roles
  • Experience with industry quality systems and standards
  • Able to influence QA strategy and apply regulatory knowledge to multiple scenarios

Education:

  • Bachelor's Degree in a Pharmacy, Chemistry, or Biology-related discipline
  • Postgraduate degree (MSC or equivalent) in science or management-related discipline, preferred

Responsibilities:

  • Contribute to global QA policies on interpretation and application of regulations
  • Provide subject matter expertise to projects
  • Support team in CAPA plan creation
  • Host external audits and inspections
  • Support QA-to-QA relationship with key clients
  • Delivery of training in performance of audits
  • Participate in global Quality initiatives aimed at improving compliance and efficiency
  • Support reporting of quality metrics and implementation of corrective actions

Randstad is an Equal Opportunity Employer. We welcome applications from diverse candidates and are committed to creating an inclusive work environment.



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