QC Testing Coordinator

Testing Coordinator (Sr. Ass. Scientist) 

Location: Leiden

Duration: 12 months

Hours: 32 or 40 hours per week

Working mode: Onsite

Imagine your next project as a QA Testing Coordinator, working at the forefront of cutting edge work and technology with one of the leading Pharmaceutical companies in the world! The testing coordinator will be responsible for coordinating all GMP and non-GMP testing, in-house and outsourced, related to release and stability of our products in development, and characterization of our products. 

Department:

The Strategic Operations group, which includes Quality Control Development, is part of the Analytical Development (AD) Department. The group is responsible for release and stability testing of our products from early stage up to commercial and all related processes ensuring efficient, effective and compliant production and testing of our products.

The Strategic Operations group accountabilities include, but are not limited to:

• Coordination of GMP and non-GMP testing internally and at external CRO’s.

• Execution of all internal testing related to release, stability, (re)qualifications of RMCR and late-stage product and process characterization. 

• Inspection, release and change management of incoming production raw materials, laboratory chemicals and Lab supplies.

• GMP Sample and Material management.

• Environmental and utility monitoring of our GMP production plant.

• GMP qualification and management of lab equipment and computerized systems 

• Maintain and develop GMP and non-GMP data systems to ensure data integrity and efficient and fast data processing.

• GMP Compliance management

roles and responsibilities

As Testing Coordinator, you are responsible for:

• The coordination of all GMP and non-GMP testing for CMC projects, which is performed in-house or is outsourced. 

• For release of batches - this process is from requesting samples to reporting of the certificate of the Analysis (CoA). 

• Coordination of the execution of the stability studies of our batches. 

• You will be the first point of contact for the relevant internal stakeholders such as our production sites, project managers and (stability) scientists, and external stakeholders such as CRO’s and CMO’s. 

• Compliance with quality standards (GMP) needs to be ensured in various processes and during regulatory inspections, internal and external GMP-audits you can act as subject matter expert. 

how to succeed

• HBO level in a life science study

• 5-10 years of experience in a pharmaceutical environment, preferably within CMC

• At least 5 years of relevant experience in process coordination

• At least 5 years of GMP experience

• Strong cross-functional collaboration with proactive communication with team members/stakeholders

• Able to translate input from many different stakeholders into concise and clear documentation/process.

• Well-developed interpersonal skills and able to build strong relationships

• Continuous improvement mindset (e.g., lean thinking)

• Experienced with laboratory or compliance management systems such as eLims systems or Veeva Vault.

• Flexible, accurate and able to prioritize own work

• Highly proficient in spoken and written English. Dutch is considered a strong plus.

details

• This role offers a very competitive hourly rate. 

• This contract will run for 12 months. 

• This is an onsite position.

you are welcome here

Johnson & Johnson Innovative Medicine is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

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: simone.strong@randstadsourceright.co.uk

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”.