Quality Control Research Associate - II*

Position Overview

We are seeking a QC Compliance & Data Review Specialist III to support quality systems, compliance oversight, and laboratory data review activities within a regulated GMP environment. This role will ensure data integrity, quality record compliance, and inspection readiness.

Key Responsibilities

  • Manage quality records, including deviations, investigations, CAPAs, and change controls.
  • Review GMP laboratory data, documentation, and supporting records for accuracy and compliance.
  • Support data integrity, compliance monitoring, and quality risk assessments.
  • Develop compliance metrics, reports, and trend analyses.
  • Author and revise SOPs and quality documentation.
  • Support audits, inspections, and continuous improvement initiatives.
  • Partner with Quality, Manufacturing, and QC teams to resolve compliance issues.

Required Qualifications

  • Bachelor's degree with 5+ years, Master's degree with 3+ years, or equivalent experience in a regulated GMP environment.
  • Experience reviewing GMP laboratory data and managing quality records.
  • Knowledge of cGMP, data integrity, CAPA, investigations, change control, and Good Documentation Practices.
  • Experience with quality management and laboratory systems.
  • Strong analytical, organizational, and communication skills.

Preferred Qualifications

  • Experience in biologics, cell therapy, pharmaceutical, or biotechnology environments.
  • Experience supporting audits, inspections, product release, or laboratory investigations.
  • Experience with compliance metrics, dashboards, or trend reporting.

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Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [email protected].