Junior Quality Assurance Associate

7555-Janssen Pharmaceutica NV Legal Entity; Geel; Sur place; EUR 42 000 - 65 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Résumé du poste

Johnson & Johnson, Geel site in Belgium, seeks a Junior QA Associate to oversee Mobile Equipment Cleaning and ensure cGMP compliance across operations. You will serve as the primary QA contact for quality activities in this area and support related supply chain processes.

The role also provides back-up QA support for Weighing, Logistics, and Powder Handling units, contributing to APRs/CPV programs and continuous improvement initiatives, while maintaining audit readiness and robust documentation

Qualifications

• Bachelor's or Master's in Chemistry/Pharmaceutical sciences or related field.
• Experience in GMP-regulated pharma environment is preferred.
• Experience with deviations, CAPAs, change controls is a plus.

Responsabilités

• Quality oversight of Mobile Equipment Cleaning area to ensure compliance with cGMP requirements.
• Review GMP documentation and support product quality investigations and CAPAs.
• Back-up QA support for Weighing, Warehouse & Logistics, and Powder Handling units.

Connaissances

Quality Assurance

cGMP compliance

Documentation control

Risk assessment

Audit readiness

Formation

Bachelor's or Master's in Chemistry/Pharma

Description du poste

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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. 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

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.
• 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
• service anniversary and recognition awards
• employees - and in some location's eligible dependents - can participate in several insurance plans.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 https://www.jnj.com/.

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