About this position
Description:
- Perform and/or oversee QC testing of GMP samples, including but not limited to Cell-based Bioassays and ELISAs.
- Independently execute complex assays and investigations with minimal supervision.
- Create, revise, qualify, and validate analytical test methods in accordance with ICH and regulatory expectations.
- Support assay development and nonclinical sample testing for IND-enabling and CMC-BLA development studies as needed.
- Perform testing in strict accordance with approved analytical methods, SOPs, and GMP documentation practices.
- Lead and support method transfers to internal laboratories and/or external contract organizations.
- Support execution of approved protocols for validation and verification of analytical instruments and test methods.
- Author and revise SOPs, test methods, validation protocols, worksheets, and controlled QC documentation.
- Provide technical troubleshooting for assays, instruments, and atypical results; lead root-cause investigations and implement CAPAs as required.
- Provide peer review of GMP data, testing packets, and validation documentation.
- Train, mentor, and technically support junior QC Analysts as needed.
- Perform general laboratory support activities including sample receipt, inventory control, reagent preparation, and equipment maintenance.
- Support equipment lifecycle management including calibration, preventive maintenance, and vendor qualification/PM scheduling.
- Ensure compliance with cGMP regulations, ICH guidelines, corporate and site SOPs, and approved specifications.
- Maintain accurate, complete, and contemporaneous GMP documentation in support of data integrity expectations.
- Actively support regulatory inspections, audits, and client interactions as needed.
- Participate in continuous improvement initiatives to enhance QC efficiency, compliance, and technical robustness.
- Perform other duties as assigned.
- Minimum 8–10 years of hands-on QC laboratory experience in a GMP environment.
- Strong working knowledge of cGMP regulations, data integrity requirements, and ICH guidelines.
- Demonstrated experience with method development, validation, qualification, and transfer.
- Proven ability to independently troubleshoot complex assays and equipment issues.
- Strong attention to detail and accuracy in data generation and documentation.
- Excellent oral and written communication skills.
- Proficiency with a wide range of analytical and bioanalytical techniques.
- Experience supporting regulatory inspections and audits is desirable.
- Bachelor’s degree with at least 8–10 years of experience in a GMP/QC setting, or Master’s degree with 6–8 years of experience in a GMP/QC setting.
Salary Information
$90000.00 - $120000.00
Annual Salary