QA Associate CSQ Lab

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:

Antwerp, Antwerp, Belgium

Job Description:

Purpose:

We are looking for a person with an analytical, scientific and quality mindset to join our dynamic multidisciplinary team as a QA Associate that will be responsible for the Beerse site compliance and operational compliance of the clinical laboratories. The QA Associate  will operationally support the daily activities including review and approval of procedures and documents for the analytical and microbiological activities, support external audits from heath authorities and customers, support/complete internal audits, participate in check rounds to supervise the compliance of the laboratory areas and the performance of the processes and activities, review and approve quality investigations and change controls, provide data for quality metrics in support of quality reporting. The QA Associate will closely interact with the other CSQ team members, our TDS business partners and other business and quality departments. Together with this exciting function in a dynamic and international environment, we ensure diversity in your work and support personal development.

Your responsibilities:

• Serves as quality point of contact for SMPD Analytical Development and Drug Product Development and their contract laboratories.

• Acts as Quality specialist for assigned analytical techniques and quality processes ensuring an appropriate quality and compliance level by applying risk management in line with the intended use and phase of development.

• Establishes and develops collaborative working relationships within and across SMPD and the global quality organization, including single quality voice in the analytical area

• Reviews and approves laboratory related documents such as validation/transfer/investigation protocols and reports

• Reviews and approves procedures and work instructions

• Handles Quality Issues, Corrective/Preventive Actions, and Change Controls related to the SMPD laboratories as well as their contract laboratories

• Ensures that Quality and Compliance operational targets are met

• Supports quality oversight via periodic quality reviews e.g. internal audits, quality metrics, check rounds.

• Works with the supported departments to maintain and continuously improve the quality culture to positively influence Quality metrics.

• Reports Quality trends and makes a positive contribution via ideas for improvement

• Supports and acts as spokesperson during Health Authority inspections and customer audits

• Travels occasionally for training or business purposes

Required skills

• Experience and affinity with the laboratory environment e.g. method development method validation, release & stability testing, microbiology, pharmaceutical development, instrument qualification, IT, automation

• Ability to work across organizational boundaries through influencing, negotiation and partnering in a global environment.

• General knowledge of pharmaceutical product development and understand how analytics contribute to this process.

• Experience with regulatory inspections as spokesperson, backroom role, preparation is an asset.

• Positively react to changes and show agile behavior e.g. dealing with different quality levels to support fit for purpose quality in an R&D environment.

• Excellent verbal and written communication skills to negotiate and connect with internal and external customers.<