Junior Quality Assurance Associate

Biopharma Careers; Geel; Sur place; EUR 52 000 - 83 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Résumé du poste

Johnson & Johnson is seeking a Junior QA Associate to provide Quality Assurance oversight for the Mobile Equipment Cleaning area and to act as the primary QA point of contact for all quality-related activities within this area, ensuring compliance with cGMP and internal procedures while supporting a reliable, compliant supply chain.

The role also backs up QA for weighing, logistics, and powder handling, contributes to site quality systems, APRs and CPV programs, delisting activities, and

Qualifications

• Thorough knowledge of cGMP regulations and pharmaceutical quality systems.
• Strong understanding of manufacturing, cleaning, qualification, validation, and supply chain processes.
• Experience with Deviations, CAPAs, Change Controls, Batch Record Review, Risk Assessments, APR/CPV processes.
• Strong analytical and problem-solving skills; able to make risk-based decisions in a fast-paced environment.
• Excellent communication and stakeholder management abilities.

Responsabilités

• Quality Oversight of Mobile Equipment Cleaning area; act as QA contact for this area.
• Review and approve GMP documentation and assess batch record exceptions.
• Support deviations, CAPAs, change controls, and investigations to ensure product quality.
• Back-up QA support for Weighing, Warehouse & Logistics, and Powder Handling Unit.
• Assist APR, CPV, and delisting processes; support inspections and audits.

Connaissances

cGMP knowledge

Quality systems

Risk assessments

Analytical skills

Formation

Bachelor's or Master's in Chemistry/Pharma/Life Sciences

Description du poste

Company Overview

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com .

Our Credo

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Quality

Job Sub Function

Quality Assurance

Job Category

Professional

All Job Posting Locations

Geel, Antwerp, Belgium

Job Description

The Junior QA Associate provides Quality Assurance oversight for the Mobile Equipment Cleaning area and serves as the primary Quality Point of Contact (SPOC) for all quality-related activities within this operational area. The role ensures compliance with cGMP requirements, internal procedures, and regulatory expectations while supporting a reliable and compliant supply chain.

In addition, the QA Associate acts as back-up Quality Support for operational departments including Weighing, Logistics, and Powder Handling Unit activities. The position contributes to site quality systems, continuous improvement initiatives, Annual Product Reviews (APRs), Continued Process Verification (CPV) programs, delisting activities, and strategic projects.

Key Responsibilities

1. Quality Oversight of Mobile Equipment Cleaning
   • Act as the primary QA Point of Contact for the Mobile Equipment Cleaning area.
   • Establish and maintain strong working relationships with operational, technical, and quality stakeholders.
   • Provide quality oversight of daily operations to ensure compliance with cGMP requirements and internal procedures.
   • Participate in operational review meetings and provide quality guidance on compliance-related topics.
   • Perform routine control walkthroughs and quality tours to verify compliance and identify improvement opportunities.
   • Promote a strong quality culture through coaching, training, and collaboration with operational teams.
2. Quality Systems Management
   • Review and approve GMP documentation related to Mobile Equipment Cleaning activities.
   • Review and assess batch record exceptions and support product impact evaluations.
   • Ensure timely and compliant handling of:
     • Deviations
     • CAPAs
     • Change Controls
     • Event investigations
     • Product Quality Complaints (where applicable)
   • Support root cause investigations and ensure robust corrective and preventive actions are implemented.
   • Escalate quality issues with potential impact on product quality, patient safety, or product supply.
3. Back-up QA Support for Operational Departments
   • Serve as QA back-up for:
     • Weighing Operations
     • Warehouse & Logistics
     • Powder Handling Unit
   • Provide quality support during absences and peak workload periods.
   • Ensure continuity of QA oversight and decision‑making across supported departments.
   • Review and approve associated GMP documentation and quality records.
4. APR, CPV and Delisting Support
   • Support the preparation and review of:
     • Annual Product Reviews (APRs)
     • Continued Process Verification (CPV) reports
     • Delisting documentation
   • Review KPI and trend‑reporting documentation related to operational quality performance.
   • Support data evaluation, trend analysis, and identification of opportunities for process improvement.
   • Ensure quality‑related commitments and actions arising from APR and CPV activities are appropriately tracked and completed.
5. Inspection and Audit Readiness
   • Support internal audits, customer audits, and Health Authority inspections.
   • Act as quality representative during audits and inspections as required.
   • Ensure inspection readiness within assigned operational areas.
   • Support the closure of observations and implementation of corrective actions.

Required Qualifications

Education

• Bachelor's or Master's degree in Chemistry, Biotechnology, Pharmaceutical Sciences, Life Sciences, or related scientific discipline.

Experience

• Minimum 3 years of experience in Quality Assurance, Quality Control, Manufacturing, or Supply Chain within a GMP‑regulated pharmaceutical environment.
• Experience with deviation management, investigation handling, and change control processes.
• Experience supporting manufacturing or operational quality activities is preferred.

Knowledge & Skills

• Thorough knowledge of cGMP regulations and pharmaceutical quality systems.
• Strong understanding of manufacturing, cleaning, qualification, validation, and supply chain processes.
• Experience with:
  • Deviations
  • CAPAs
  • Change Controls
  • Batch Record Review
  • Risk Assessments
  • APR/CPV processes
• Strong analytical and problem‑solving skills.
• Ability to make risk‑based decisions in a fast‑paced environment.
• Excellent communication and stakeholder management skills.
• Ability to work independently while maintaining strong cross‑functional partnerships.
• Continuous improvement mindset with a focus on compliance and operational excellence.

Required Skills

Preferred Skills

• Business Alignment
• Business Behavior
• Coaching
• Compliance Management
• Continuous Improvement
• Data Analysis
• Detail‑Oriented
• Goal Attainment
• Human-Centered Design
• Internal Controls
• Issue Escalation
• Problem Solving
• Process Oriented
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards

Salary Range

€52000,00 - €82685,00

Benefits

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.