SummaryUnder minimal supervision, the Quality Associate ensures GMP/GDP compliance of procedures and records across Manufacturing, Support Functions, and QC Laboratories. The role governs documentation in the DCA/eDMS system, evaluates data integrity in paper and electronic records, authors sampling plans using AQL criteria, and drives remediation, change control, and training effectiveness. The associate acts as a process improver and partner to operations to prevent recurrence of documentation and GDP errors.Major Duties & ResponsibilitiesDocumentation & GDP ComplianceReview CRs, SOPs, BRs, Forms, Logbooks, BOMs, WPPs, and qualification/validation protocols for GDP and electronic data compliance.Identify gaps; provide guidance and coordinate remediation activities with record owners.Own procedure and form changes in DCA/eDMS; manage revision/approval workflow and ensure training is completed and effective.Sampling & Data IntegrityDevelop sampling plans using Acceptance Quality Level (AQL) criteria for additional/special testing.Evaluate procedures/forms for Data Integrity (ALCOA+) requirements; execute forms FMEA to assess risk/criticality and define actions.Risk & Change ControlEvaluate, modify, and implement Risk Assessments; initiate and coordinate change controls through approval and implementation.Support and track CAPA and continuous improvement initiatives in sterile and non-sterile areas.Operations SupportAssess GDP compliance during protocol execution; work with operations to prevent recurrent errors.Provide training on planning/quality processes and documentation practices to intra/inter-departmental staff.Represent QA in cross-functional forums; escalate issues with sense of urgency and propose data-driven solutions.Decision MakingActs with autonomy to initiate reviews, remediation, and escalations; poor decisions may impact compliance and business continuity.Demonstrates analytical thinking, prioritization, and effective stakeholder engagement to resolve quality issues promptly.QualificationsBachelor’s degree in Science/Engineering or related discipline (Chemistry, Biology, Microbiology, Industrial/Mechanical/Quality Engineering) preferred.3+ years in GMP manufacturing/QC with strong GDP and data integrity experience.Hands-on with DCA/eDMS (e.g., Veeva/Infinity/Documentum) and training effectiveness management.Proficiency in MS Office; working knowledge of AQL, FMEA, Risk Assessment, Change Control, and CAPA.Excellent technical writing, organization, and facilitation skills; able to work with minimal supervision.Bilingual (Spanish/English) strongly preferred.Nice to HaveExperience in sterile operations, protocol execution oversight, and electronic systems (LIMS, MES, eBR).Familiarity with data integrity investigations and audit support.
