Quality Control Analyst - Analytical 3rd Shift

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 is a 3rd shift position

This individual is responsible for routine QC testing on cleaning, in-process and release samples. The individual will also assist analytical method transfers and method qualifications between the Analytical Development group and Quality Control (QC). The QC analyst must demonstrate strong technical knowledge, be familiar with basic scientific/regulatory principles, possess initiative, and maintain a strong commitment to scientific excellence.

Key Responsibilities include but are not limited to:

• 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
• 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 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
• Produce results in a fast-paced environment in order to meet client deadlines, and under minimal supervision
• Ability to learn quickly with a desire for continual development and improvement
• Apply basic scientific and regulatory principles in order to solve operations, as well as routine tasks, in the QC department
• Ability to work within a team setting as well as independently
• Analyze data and complete reports with attention to detail

Education & Experience:

• Bachelor in a Life Sciences discipline and 2 or more years of experience working in a QC laboratory (will consider reduced experience with increased levels of education in same field)
• HPLC knowledge/experience required
• 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
• Broad experience with biochemistry, 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

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 an individual with a disability, or other applicable legally protected characteristics.

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