Salary Range:
€44,100.00 - €81,900.00
Job Description Summary
#LI-Onsite
Location: Baarle Nassau, Netherlands
This role is primarily on-site, with approximately 80% of working time spent on-site and 20% working from home, subject to agreement. The position is offered as a temporary contract, with the possibility of extension or conversion to a permanent role. Weekend work may be required as part of a team-based rotation.
Relocation Support: This role is based in Baarle Nassau, Netherlands. Novartis is unable to offer relocation support: please only apply if accessible.
The QC Specialist Microbiology & Compliance acts as Point of Contact and Subject Matter Expert (SME) for QC compliance, environmental monitoring (EM), aseptic and cleanroom practices at the site. The role ensures compliant, consistent and efficient microbiological and QC operations in support of batch release, contamination control strategy, and regulatory requirements. The role contributes to the quality control processes, acting as backup to provide operational support in QC release testing (product and materials) as needed.
Job Description
Key Responsibilities
- Own and govern the site Environmental Monitoring (EM) program (cleanrooms, utilities, personnel).
- Perform trending and signal detection, define alert/action limits and ensure alignment with contamination control strategy.
- Act as primary trainer/qualifier for aseptic techniques and microbiological practices, and standardise training content across teams and shifts.
- Lead continuous improvement of EM and aseptic processes and methods.
- Ensure timely escalation of adverse trends and impact on product quality.
- Own and lead investigations related to laboratory, microbiological and aseptic events.
- Ensure compliance with GMP, Annex 1, contamination control expectations and act as SME during audits and inspections.
- Support change controls, risk assessments, and quality impact evaluations.
- Perform deviation trending, recurring deviations assessments to enhance and maintain compliance levels of the QC team.
- Act as TMS-C
- Act as backup to provide operational support in QC release testing (product and materials) as needed. Ensure testing continuity during weekends, absences, or peak demand.
Essential Requirements
- Bachelor’s or Master’s Degree in Microbiology, Biology or related field.
- 3+ years of experience in pharmaceutical QC laboratory, aseptic environments or company equivalent in a strongly regulated environment.
- Experience with Environmental monitoring & cleanroom classification.
- Excellent knowledge of good laboratory practices and cGMP.
- Familiarity with GMP and Annex 1 requirements is highly desirable.
- Experience or knowledge on radiopharmaceutical environments is recommended.
- Open and clear collaboration and communication with third parties.
- Fluent Dutch and English, written and spoken.
Desirable requirements:
- Experience in a radiopharmaceutical, biotech, or analytical laboratory environment is preferred.
Rewards
At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.
The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and a minimum of 14 weeks paid parental leave.
Expected Annual Base Salary Range for role:
The salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.
In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. Further details will be provided during the application process.
Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.
Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.
Commitment to Diversity and Inclusion / EEO paragraph:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Skills Desired
