Summary

Under 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 & Responsibilities

• Documentation & GDP Compliance

  • Review 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 Integrity

  • Develop 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 Control

  • Evaluate, 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 Support

  • Assess 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 Making

• Acts 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.

Qualifications

• Bachelor’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 Have

• Experience in sterile operations, protocol execution oversight, and electronic systems (LIMS, MES, eBR).

• Familiarity with data integrity investigations and audit support.