Quality Control Analyst III

Company: Experis
Location: Crofton
Posted on: September 17, 2020

Job Description:

Job Title Quality Control Analyst III 1st shift 8-5pm w potential of 20 hours of OT. Nights and weekends may be needed. Description This Quality Control Analyst III - Method Transfer Validation role will focus on the transferqualificationValidation 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 scientificregulatory principles, possess initiative, and maintain a strong commitment to scientific excellence. 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. Position workweek is Monday through Friday and will reside at our HarmansBWI site. The Role Experience with the transferqualificationValidation of GMP assays such as ELISA, qPCR, RT-PCR, HPLC and Capillary Electrophoresis. Perform assays such as ELISA, DNARNA 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 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 interpretationpresentation, statistical analysis, and trending. The Candidate 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 knowledgeexpertise 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 AssuranceQC function with a strong familiarity of general GMP practices. Experience in writing SOPs and test methods as well as method qualificationvalidation documentation. Broad experience with biochemistry and biological assay support, as well as generatingreviewing 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. We will identify candidates based on the following Leads with Integrity and Respect Delivers Results Demonstrates Business Acumen Fosters Collaboration and Teamwork Champions Change Engages and Inspires Coaches and Develops ManpowerGroup is an Equal Opportunity Employer (EOEAA)

Keywords: Experis, Baltimore , Quality Control Analyst III, Professions , Crofton, Maryland