[Remote] Remediation Complaints Analyst
Note: The job is a remote job and is open to candidates in USA. TekWissen is a global workforce management provider specializing in digital transformation and business process management. They are seeking a Remediation Complaints Analyst responsible for reviewing and correcting complaint records to ensure compliance with regulatory requirements and company procedures.
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
Skills
- 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
Company Overview