Regulatory Complaints Remediation Analyst

TekWissen ®; United States; On-site; USD 60,000 - 80,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Communication skills

Attention to detail

Problem solving skills

Analytical skills

Organizational skills

Multitasking

Interpersonal skills

Customer service skills

Education

Associate degree in science or related field

Advanced degree considered in lieu of experience

Tools

Complaint database software

Reporting tools

Word processors

Job description

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.