The Quality Control Lead Analyst (2nd Shift) is responsible for routine QC testing on cleaning, in-process and release samples. The QC Lead Analyst will also assist analytical method transfers and method qualifications between the Analytical Development group and Quality Control (QC). This individual will be responsible for assisting with the monitoring of the day to day operations within the QC laboratory. The QC Lead Analyst must demonstrate strong technical knowledge, be familiar with basic scientific/regulatory principles, possess initiative, and maintain a strong commitment to scientific excellence.
This is a second shift position that will reside roughly on a 4pm-12am schedule and will report to the QC Supervisor at our Harmans/BWI site.
Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.
The Role/Job Duties:
- Perform assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, RT-PCR, ddPCR, HPLC, Capillary Electrophoresis, and Compendia.
- Generate internal and external documents such as assay protocols, summary reports, and SOPs.
- Work with clients during initial and subsequent transfer of assays and analytical methods to support GMP manufacturing campaigns.
- Provide instrumentation care, maintenance, troubleshooting, and data interpretation.
- Work on project teams developing and improving assays.
- Work under general supervision to meet project goals.
- Work closely with Manufacturing and Quality Assurance staff to resolve quality issues with regard to the facility and products manufactured.
- Document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending.
Experience & Education:
- Bachelor in a Life Sciences discipline and 6 or more years of experience working in a QC laboratory (will consider reduced experience with increased levels of education in same field).
- Team lead or leadership experience.
- Considerable knowledge/expertise relevant to QC analytical methods used for protein chemistry and molecular biology.
- Experience within the biologic, pharmaceutical, or medical device industry performing direct hands-on work in a Quality Assurance/QC function with a strong familiarity of general GMP practices.
- Experience in writing SOPs and test methods as well as method qualification/validation documentation.
- Broad experience with biochemistry and biological assay support, as well as generating/reviewing the documentation that supports such work.
- Possesses the knowledge and ability to apply basic scientific and regulatory principles to solve operational, as well as routine quality tasks.
- Ability to succeed in a team-oriented environment under very dynamic conditions.