Quality Control Analyst - Method Qualification & Validation
Paragon BioServices, Inc.
Baltimore, Maryland, United States
Job type: fulltime
Job industry: Other
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.
Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses.
This individual is responsible for analytical method transfers and method qualifications between the Analytical Development group and Quality Control (QC). This individual will also be responsible for method validation in QC and may assist with routine testing as needed. The QC analyst must demonstrate strong technical knowledge, be familiar with advanced scientific/regulatory principles, possess initiative, and maintain a strong commitment to scientific excellence.
Key Responsibilities include but are not limited to:
- Has considerable knowledge/expertise relevant to QC analytical methods used for protein chemistry and molecular biology. Knowledge/expertise should be practical and focused on lab-related activities:
- Experience with the transfer/qualification/Validation of GMP assays such as ELISA, qPCR, RT-PCR, HPLC and Capillary Electrophoresis
- Perform assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, RT-PCR, HPLC and Capillary Electrophoresis
- Generate internal and external documents such as assay protocols, summary reports, and SOPs
- Assist with investigations related to assay performance
- Work on project teams developing and improving assay
- 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 under general supervision to meet project goals
- Work closely with Analytical Development Assurance to resolve technical issues during qualification testing/transfer
- 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 4 or more years of experience working in a GMP QC laboratory with some or all of that time focused on the transfer & validation of QC analytical methods used for protein chemistry and molecular biology. Will consider a Master's degree in a Life Science field with 2 years of experience.
- 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
Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as anindividual with a disability, or other applicable legally protected characteristics. #LI-EW1