Quality Analyst

Quality Analyst 1 - On-site in Frederick, MD Must be able to work on a W2Performs selected quality assurance activities, dependent upon the assigned area, including the following:Reads, understands and follows SOPs and complies with cGMPsWrites new standard operating procedures or revises existing documentation utilizing document management systems.Supports the evaluation and disposition of labeling, raw materials, intermediates, and finished products through timely evaluation of batch records, laboratory results, and other cGMP documents.Supports the issuance and reconciliation of GMP documentationElectronic system usage with tools such as Trackwise, GQCLIMS, Pas-X, and SAP.Works under regular and routine supervision following standard procedures.Receives detailed instructions for new assignments.Priorities are set by others.Work is reviewed for accuracy and completeness.Contributes to department goals through quality and efficiency of standard work.Qualifications Understands basic scientific principles and cGMP.Basic knowledge of functional procedures and routine activities within core area.Applies knowledge to recurring, standardized tasks.Uses basic analytical skills to develop solutions to task-related problems.Escalates/seeks support for more complex problems as appropriate.Years of experience:Education: Minimum of Associate degree (or equivalent) in science-related field0-3 years experience in biopharmaceutical/pharmaceutical industry.Bachelors degree or 4 additional years of work experience in lieu of degreeAA or 2 additional years of work experience in lieu of a degree

Created: 2024-11-09