QC Separation Analyst Job Summary:
The ideal candidate will be responsible for executing laboratory testing activities to support in-process and release testing of biotechnology products. This role involves reviewing and approving laboratory test results, performing analytical testing activities, and ensuring that all methods meet relevant guidelines.
Key Responsibilities:
* Executing laboratory testing activities to support in-process and release testing of biotechnology products
* Reviewing and approving laboratory test results
* Performing analytical testing activities to ensure compliance with ICH, USP, and EP guidelines
* Validating, operating, maintaining, calibrating, and troubleshooting equipment and its associated software
* Writing and executing reports, as well as reviewing IQ/OQ and PQ protocols to ensure qualification of equipment for cGMP use
* Ensuring timely completion, review, and approval of testing activities
* Maintaining QC activities in compliance with product license commitments, cGMP, and company quality standards
* Providing training and guidance to other QC analysts on laboratory methods and procedures
* Updating and reviewing technical documents, such as TMs, SOPs, and WIs, as required
* Communicating relevant issues to the QC Team Leader promptly
Required Skills and Qualifications:
* Bachelor's degree in a scientific or technical discipline
* Minimum 2 years' experience in a QC laboratory-testing environment within the biological and/or pharmaceutical industry
* Proven experience with HPLC, Capillary Electrophoresis, UPLC/Mass Spec
Benefits:
This role offers opportunities for professional growth and development, as well as the chance to contribute to a team dedicated to delivering high-quality results.
How to Apply:
To be considered for this exciting opportunity, please submit your application with a detailed resume and cover letter outlining your relevant experience and qualifications.