What are the responsibilities and job description for the Quality Control Data Reviewer III position at Hartmann Young?
Quality Control Data Reviewer III - CDMO
Hartmann Young is partnered with a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotechnology companies to support the development, manufacture, and delivery of therapies for patients. We are looking for a Quality Control Data Reviewer III to join the team in Rensselaer, New York.
The Role
You will review and approve analytical data generated from QC laboratory testing to ensure compliance with cGMP guidelines and data integrity requirements. You will perform technical reviews of analytical data from a range of laboratory instrumentation, verify calculations, sample traceability and documentation, and ensure testing is completed in accordance with established SOPs and regulatory standards. You will also collaborate with Quality Assurance and laboratory teams, support investigations and continuous improvement initiatives, and provide guidance to analysts to promote compliance across QC operations.
The Person
Required
- Bachelor's Degree in Natural Science, Pharmacy or a related scientific discipline;
- Minimum of 5 years of QC laboratory or relevant pharmaceutical industry experience;
- Experience working within a cGMP or GLP pharmaceutical environment;
- Strong knowledge of analytical data review and laboratory documentation;
- Previous experience reviewing analytical data generated from techniques such as HPLC, GC, Karl Fischer or other analytical instrumentation.
Preferred
- Experience working within a commercial pharmaceutical QC laboratory;
- Knowledge of method validation, method transfer and stability testing;
- Experience supporting investigations, change controls or Quality Assurance initiatives;
- Strong understanding of FDA cGMP regulations and data integrity requirements.
The ideal candidate will demonstrate excellent attention to detail, strong analytical and problem-solving skills, and the ability to make sound technical decisions in a regulated laboratory environment. They will possess a thorough understanding of cGMP principles, analytical testing, laboratory documentation and data integrity, together with excellent organisational and communication skills and the ability to manage multiple priorities while maintaining the highest quality standards.
If this sounds like you, please apply here or reach out on joe.boyd@hartmannyoung.com - we'd love to hear from you!
Please note - relocation support is available for this position.