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 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 3 different shifts:
M-F, Split Shift - 11:00a-8:00p
Key Responsibilities include but are not limited to:
Perform routine testing such as filter integrity testing, TOC, pH, conductivity and HPLC. Experience with ELISA testing preferred but not required.
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 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.
Associated topics: biomedical, dietetic, drug discovery, histotechnologist, medicine, microbiological, nutrition, nutritionist, pharmacy, transfection
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.