Remediation Complaints 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 a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a global professional services firm specializing in digital transformation, business process management (BPM), analytics, and AI-driven solutions. The company partners with organizations to improve efficiency, transform operations, and drive business outcomes through a combination of process expertise, technology, and data insight.

Job Summary

The Remediation Complaints Analyst is responsible for reviewing complaint records identified during the retrospective review and correcting deficiencies in accordance with regulatory requirements and company procedures.

This role performs detailed complaint assessments, completes missing documentation, supports investigations, and ensures complaint files are accurate, complete, and audit ready.

The analyst works closely with Quality, Regulatory Affairs, and subject matter experts to resolve gaps and maintain project timelines.

In addition, the role documents all remediation activities and supports the preparation of metrics and reports for management and regulatory review.

Day to Day Responsibilities

• Review complaint records identified for remediation.
• Assess complaint files for missing documentation, approvals, or required actions.
• Complete and document remediation activities in ETQ.
• Support the completion of missed investigations and follow-up activities.
• Reassess complaint records for regulatory reporting requirements when needed.
• Gather and attach supporting documentation to complaint files.
• Ensure complaint records comply with SOPs and regulatory requirements.
• Coordinate with Quality, Regulatory Affairs, and product SMEs to resolve questions.
• Document findings and remediation actions in project tracking tools.
• Escalate potential patient safety or regulatory concerns to management.
• Support CAPA evaluations and provide information for systemic issue assessments.
• Participate in team calibration sessions to ensure consistency across reviewers.
• Meet daily and weekly to review productivity and quality targets.
• Maintain complete and audit-ready documentation for all remediation activities.
• Provide status updates and support the preparation of project metrics and reports.

Knowledge, Skills and Equivalent Experience

• Associate degree in science or related field of study
• Related experience within the pharmaceutical industry. Will consider an advanced degree in lieu of years of experience.
• Strong verbal and written communication skills in English
• Problem solving skills
• Adept at attention to detail
• Strong understanding of Good Documentation Practices
• Good organizational skills
• Analytical skills
• Self-motivated/directed
• Computer literate—proficient in use of word processors.
• Must be able to understand and utilize complaint database software and reporting tools.
• Knowledge of cGMPs and Code of Federal Regulations regarding drugs, medical devices, combination products and biologics
• Project and time management skills
• Interpersonal skills—must be proactive, personable, flexible, team-oriented
• Customer service skills
• Ability to multitask in a highly stressful environment
• Ability to operate in a constantly changing environment

TekWissen Group is an equal opportunity employer supporting workforce diversity.