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