[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.ResponsibilitiesReview complaint records identified for remediationAssess complaint files for missing documentation, approvals, or required actionsComplete and document remediation activities in ETQSupport the completion of missed investigations and follow-up activitiesReassess complaint records for regulatory reporting requirements when neededGather and attach supporting documentation to complaint filesEnsure complaint records comply with SOPs and regulatory requirementsCoordinate with Quality, Regulatory Affairs, and product SMEs to resolve questionsDocument findings and remediation actions in project tracking toolsEscalate potential patient safety or regulatory concerns to managementSupport CAPA evaluations and provide information for systemic issue assessmentsParticipate in team calibration sessions to ensure consistency across reviewersMeet daily and weekly to review productivity and quality targetsMaintain complete and audit-ready documentation for all remediation activitiesProvide status updates and support the preparation of project metrics and reportsSkillsAssociate degree in science or related field of studyRelated experience within the pharmaceutical industry. Will consider an advanced degree in lieu of years of experienceStrong Verbal and Written Communication Skills in EnglishProblem Solving SkillsAdept at Attention to DetailStrong understanding of Good Documentation PracticesGood organizational skillsAnalytical skillsSelf-motivated/directedComputer literate—proficient in use of word processorsMust be able to understand and utilize complaint database software and reporting toolsKnowledge of cGMPs and Code of Federal Regulations regarding drugs, medical devices, combination products and biologicsProject and Time Management SkillsInterpersonal skills-must be proactive, personable, flexible, team-orientedCustomer Service SkillsAbility to multitask in a highly stressful environmentAbility to operate in a constantly changing environmentCompany OverviewWelcome TekWissen, your premier partner in technology consulting, workforce solutions, payroll services, procurement, managed services, global capability centers, and venture capital support, specifically tailored for startups in the human capital sector. It was founded in 2009, and is headquartered in Ann Arbor, Michigan, USA, with a workforce of 1001-5000 employees. Its website is http://tekwissen.com.