Perform comprehensive reviews of QC batch records, analytical data, deviations, and investigations to ensure compliance with cGMP requirements and approved procedures.
Review analytical test results, raw data, chromatograms, calculations, and supporting documentation against established specifications and methods.
Identify, document, and escalate discrepancies, errors, and non-conformances, ensuring appropriate corrective actions and investigations are initiated.
Collaborate closely with Quality Assurance, Manufacturing, and QC laboratory teams to resolve documentation and quality-related issues and support timely product release.
Maintain accurate and audit-ready documentation related to batch review and release activities.
Participate in root cause investigations, deviation management, and CAPA activities to drive continuous improvement.
Support internal and external audits and contribute to ongoing improvements within QC and batch release processes.
Requirements
Bachelor's degree in Chemistry, Biochemistry, Pharmacy, or a related scientific discipline.
Minimum of 3 years of experience in a Quality Control or Quality Assurance role within the pharmaceutical or biotechnology industry.
Strong knowledge of cGMP regulations and quality systems, including FDA, EMA, and ICH guidelines.
Experience reviewing analytical data generated from techniques such as HPLC, flow cytometry, cell counting, UV/Vis spectroscopy, and microbiological testing.
Excellent attention to detail with strong analytical and problem-solving skills.
Ability to work effectively both independently and collaboratively in a fast-paced, regulated environment.
Strong written and verbal communication skills in English; experience with electronic document management systems (EDMS) and ERP systems is advantageous.
About Lonza
Ready to shape the future of life sciences?
Benefits
Remote work options
Additional Information
QC Batch Reviewer
Geleen, Netherlands
The actual location of this job is in Geleen, Netherlands.
Join Lonza's Quality Control team in Geleen and play a critical role in ensuring the quality, safety, and compliance of pharmaceutical products. This position offers the opportunity to work cross-functionally with Manufacturing, Quality Assurance, and QC teams while contributing directly to the timely release of medicines that improve patient lives.
This is a primarily site-based role. Working together in person supports close, real-time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards. We offer flexibility to work remotely for no more than 20% of your time. Requests are considered on a case-by-case basis, in line with business needs.
What you will get
An agile career and dynamic working culture.
An inclusive and ethical workplace.
Compensation programs that recognize high performance.
A variety of benefits dependent on role and location.
Opportunities for professional development and growth within a global life sciences organization.
Exposure to cross-functional teams and diverse pharmaceutical manufacturing processes.
The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits
The full-time annual base pay for this position in the Netherlands is expected to range between EUR 41,250 and EUR 57,750. Initial salary placement within this range will be determined based on role-related factors such as experience, qualifications, and expected contribution.
Lonza · Netherlands