QA Specialist- Regulatory Affairs

Job Description Summary

The Systems QA Specialist provides Quality System (QMS) support and oversight for a sterile manufacturing site operating terminal sterilisation within an aseptic filling environment. The role focuses on strengthening and maintaining compliant quality systems that enable safe, effective, and timely product supply. Working cross-functionally with Manufacturing, Engineering, Validation, QC Microbiology/QC Labs, and Supply Chain, the Systems QA Specialist supports site performance through robust documentation, change control, deviation/CAPA management, risk management, and inspection readiness.

This is a support role (not final release authority). The role contributes to quality decisions through thorough assessment, escalation, and documentation in line with site procedures.

Job Description

Responsibilities

QMS Management & System Oversight (Primary Focus)

• Support end-to-end execution of core QMS processes within assigned areas:
  Deviations/Nonconformances, CAPA, Change Control, Risk Assessments, Document Control, and Training Compliance.

• Ensure QMS records are initiated, assessed, progressed, and closed within SLA and meet data integrity and GDP expectations.

• Support routine system health activities: periodic reviews, metrics/KPIs, trending, and continuous improvement actions.

• Maintain and support inspection readiness through strong system discipline, clear traceability, and effective evidence packs.

Change Control & Technical Quality Support (Sterile Systems)

• Support and/or coordinate change controls affecting sterile operations, terminal sterilisation processes, equipment, utilities, and supporting systems.

• Ensure changes are risk assessed (e.g., product impact, sterility assurance impact), appropriately documented, and aligned with validation/qualification requirements.

• Partner with Engineering/Validation to ensure implementation readiness: SOP updates, training completion, validation documentation, and effective handover to operations.

Deviation Investigation & CAPA Support

• Support investigations for process, equipment, utilities, documentation, and microbiology/EM-related events, ensuring structured root cause analysis.

• Drive high-quality problem statements, impact assessments, containment actions, and timely CAPA development.

• Support CAPA effectiveness checks and ensure learnings are embedded to prevent recurrence.

Terminal Sterilisation & Sterility Assurance Systems Support

• Provide QA system support for terminal sterilisation lifecycle activities, including:

  • Sterilisation cycle documentation control and review support (as per site procedures)

  • Change management and validation alignment for steriliser cycles, load patterns, and critical parameters

  • Support for sterility assurance risk assessments and periodic reviews

• Interface with QC Microbiology for system-level trending and governance of sterility assurance metrics (e.g., EM trends, excursions, recurring themes).

Documentation & Training Compliance

• Author, review, and/or approve controlled documents (SOPs, WIs, forms, templates) supporting sterile operations and terminal sterilisation systems.

• Ensure training requirements are defined and tracked; support training effectiveness where required.

• Promote Good Documentation Practices (GDP), right-first-time behaviours, and consistent use of approved templates.

Audit & Inspection Support

• Support internal audits, supplier quality interfaces (as applicable), and regulatory/customer inspections:

  • Prepare evidence packs and system narratives

  • Support responses to observations and timely closure of actions

  • Ensure records are inspection-ready with strong traceability and rationale

Continuous Improvement

• Identify opportunities to streamline QMS workflows while maintaining compliance (e.g., standardised investigation templates, improved change control quality, trending dashboards).

• Support site quality initiatives impacting sterile systems performance (e.g., CCS alignment, aseptic governance, documentation simplification).

Key Interfaces

• Manufacturing / Aseptic Filling Operations (system support, documentation, deviation/change coordination)

• Engineering & Validation (qualification/validation alignment, sterilisation systems changes)

• QC Microbiology / QC Labs (EM trend governance, micro-related system actions)

• Supply Chain / Materials (change control, supplier quality topics as applicable)

• Quality Leadership / QP/QA Release Teams (escalation, risk assessment input, readiness support)

Required Qualifications

• Bachelor’s degree (or equivalent experience) in Science, Engineering, Pharmacy, or related discipline.

• Experience in GMP Quality Assurance or Quality Systems within sterile/aseptic manufacturing or similarly regulated environments.

• Hands-on experience supporting QMS processes: deviations, CAPA, change control, documentation (and ideally risk management).

• Strong understanding of GDP and data integrity expectations.

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Behaviors

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Total Rewards

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Additional Information