Quality Control Analyst - Analytical

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, Gaithersburg & 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 role is responsible for routine QC testing on cleaning, in-process and release samples. The QC analyst must demonstrate technical knowledge, be familiar with basic scientific/regulatory principles, possess initiative, and maintain a strong commitment to scientific excellence.

Paragon is hiring for first shift

Key Responsibilities include but are not limited to:

• Perform routine testing such as HPLC, PCR & SDS Page
• Generate testing records and report results
• 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

Education & Experience:

• Bachelor in a Life Sciences discipline and 5 or more years of experience working in a QC laboratory (will consider reduced experience with increased levels of education in same field)
• 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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