Regulatory Complaints Remediation Analyst

TekWissen ®

United States

Sur place

USD 60 000 - 80 000

Plein temps

14 jours+

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Résumé du poste

TekWissen ® is hiring a Remediation Complaints Analyst responsible for reviewing complaint records and correcting deficiencies to meet regulatory requirements. This role involves detailed assessments and collaboration with Quality and Regulatory Affairs to ensure accurate documentation.

The ideal candidate should have an associate degree in a related field, experience in the pharmaceutical industry, and strong communication and analytical skills. This position operates in a dynamic environment and offers a chance to support essential compliance activities.

Qualifications

  • Experience within the pharmaceutical industry.
  • Strong understanding of Good Documentation Practices.
  • Ability to operate in a constantly changing environment.

Responsabilités

  • Review complaint records identified for remediation.
  • Complete and document remediation activities in ETQ.
  • Ensure complaint records comply with SOPs and regulatory requirements.
  • Document findings and remediation actions in project tracking tools.
  • Provide status updates and support the preparation of project metrics and reports.

Connaissances

Communication skills
Attention to detail
Problem solving skills
Analytical skills
Organizational skills
Multitasking
Interpersonal skills
Customer service skills

Formation

Associate degree in science or related field
Advanced degree considered in lieu of experience

Outils

Complaint database software
Reporting tools
Word processors

Description du poste

TekWissen ® is hiring a Remediation Complaints Analyst responsible for reviewing complaint records and correcting deficiencies to meet regulatory requirements. This role involves detailed assessments and collaboration with Quality and Regulatory Affairs to ensure accurate documentation.

The ideal candidate should have an associate degree in a related field, experience in the pharmaceutical industry, and strong communication and analytical skills. This position operates in a dynamic environment and offers a chance to support essential compliance activities.

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