Quality Control Analyst - Method Qualification Validation
116 Lexington Dr
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Paragon Bioservices, Inc. (PBI) is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Paragon Bioservices provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a PBI employee, you will actively contribute to the delivery of our services and products to our customers and their patients.
This Quality Control Analyst role will focus on the transfer/qualification/Validation of GMP biologic assays such as ELISA, qPCR, RT-PCR, HPLC and Capillary Electrophoresisis. 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 3 different shifts:
M-F, Split Shift - 11:00a-8:00p
Key Responsibilities include but are not limited to:
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 assays
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
Education & Experience:
Bachelor in a Sciences discipline and 4-6 years of experience working in a GMP Quality Control Lab with some or all of the time working with method transfer & qualification.
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
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.