Quality Assurance Associate

Quality Assurance Associate

Location: Leiden 

Duration: 12 months contract

Hours: 40h - 32h 

Hybrid way of working

Imagine your next role as a Quality Assurance Associate where you will provide QA support to the introduction of New Products to the Leiden manufacturing site. 

You will act as the primary point of contact for New Products quality-related topics within the site and you will provide Quality oversight to the method/process qualification, validation, and manufacture of API (Biologicals) and/or Drug Substances (Vaccines) for clinical studies (phase I, II, III) or for Emergency use (e.g., COVID-19 vaccine). 

About the department 

Johnson & Johnson Innovative Medicine is a multinational pharmaceutical company that has been for more than 25 years a leader in the field of biomedicines. Through the dynamic science of biotechnology, we continue to seek innovative ways to treat cancer, infectious diseases, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders (I.M.I.D.s).

As Quality Assurance we take a stand to consistently ensure the delivery of safe, cost effective and high-quality products for the patients in need. The QA department has an OCP (Operational Commercial Products) and an NPD (New Product Development) & Launch branch.

In addition to the base business activities for our products, the company also has a large project portfolio to improve on our processes, implement new technologies, and increase our capacity to be able to deliver future demands.

Main Responsibilities

• Participates as Core Team Member in New Product Introduction projects

• Provides Quality oversight to the introduction of New Products (Biologicals and / or Vaccines) to the site

• Assesses the Quality Issues for possible impact on product quality, process or compliance status and makes recommendation on product disposition (e.g., Harvest, Intermediates, (P)FB or Drug Substances). Reviews/approves the outcome of Quality Investigations, provides support as part of the investigation teams, and monitors the quality of the Assignable or Root Cause investigations. 

• Escalates serious quality, compliance and /or GMP incidents to Site or Global Management

• Setup and coordinate Site and Global escalation meetings

• Provides Quality support for the development of appropriate Corrective and Preventative actions and provides Quality approval

• Ensures that the local Non-Conformance and CAPA programs are improved with gaining knowledge from the process

• Participates in risk assessments to ensure compliance or quality is not jeopardized

• Coordinates, reviews, and provides GMP training (e.g., Non-conformances, Investigation techniques, CAPA etc.) for site colleagues to ensure compliance to cGMP and company training requirements.

• Is involved in initiatives that lead to a higher quality and compliance culture throughout the organization, including GEMBA walks in manufacturing areas and laboratories

• Provides review and approval of document changes and change controls

• Optimize current and identify new ways of process and quality monitoring

• On a rotation basis is available 24/7 as QA representative for Quality issues

• Acts as quality SME and participates in the preparations for (APR, Inspection readiness reports) and during inspections (FDA, EMA etc.) to accomplish a successful audit.

• Reviews and approval of maintenance notifications and work orders 

• Reviews & approves change controls.

• Partners with site colleagues to ensure all site changes (e.g., to production processes, equipment, and systems) are conducted in a controlled and systematic manner and conform to cGMP and other regulatory requirements.

• Leads and supports facility in identifying and eliminating compliance risks.

• Acts as a quality representative and provide expertise to manage and participate in JBV projects to ensure compliance to cGMP and company quality requirements.

• Assesses, reviews, and approves study protocols and reports to assure that studies will be executed in a controlled and systematic manner conform cGMP and regulatory requirements e.g., but not limited to stability, validation, analytical technical transfer

• Acts as a member in Quality Risk Management and /or root cause investigation sessions.

The ideal candidate for this position should have:

• Bachelor’s degree or higher in Biochemistry, Biology, Pharmaceutical degree or relevant education.

• Experience in a GMP regulated environment (manufacturing, QA and/or QC)

• Experience in methods such as Process Excellence, Co Think or Kepner-Tregoe is recommended.

• Proven knowledge of the biotechnological/pharmaceutical industry

• Proficiency in English both in words and in writing

• Deep understanding and application of Global Regulatory (cGMp/ICH/FDA/EMA) guidelines in Operations environment.

• Functions independently in a complex environment to make daily judgments to balance business needs, regulatory requirements, and cost efficiency for all Quality decisions. Is required to determine the level of risk, magnitude and/or complexity in order to make sound judgments on when to escalate critical issues to Quality management.

• Broad knowledge of QA systems (i.e., change control, deviation management, cGMP, validation) manufacturing and laboratory processes, facilities and utilities, and technical automation.

• Problem-solving and troubleshooting to initiate fresh, innovative, and compliant solutions to manage unexpected quality issues. 

• Ability to drive collaboration in a fast-paced environment 

• Good negotiation skills with a customer-oriented attitude. Influences (without formal authority) and engages colleagues throughout the site and manages diversity and conflicting viewpoints.

• Empowered professional who can make well-motivated pragmatic decisions on their own.

benefits

This role offers a competitive hourly rate & a supportive working environment. This contract will run initially for12 months. 

About Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

https://www.jnj.com/

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. 

questions

If you would like some additional information about the role please contact:  katerina.alikaridou@randstadsourceright.nl

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.