Quality Control Chemist

Location: Frederick, MD Onsite - Shift flexibility preferred .Quality Control Chemist | Requirement :Bachelor's Degree OR AA Degree and 2+ years' experience in biotechnology or related field and Quality Control experience O RHigh School Degree and 3+ years' experience in biotechnology or related field and Quality Control experience .Strong knowledge of GMP, SOPs and quality control processes .Identifying, writing, evaluating, and closing OOS's and investigations .Proficient in MS Word, Excel, Power Point and other applications .Strong written and verbal communication skills .Ability to communicate and work independently with scientific/technical personnel .Well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals .Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211) .Preferred: Experience in the biotech and/or pharmaceutical industry Quality Control Chemist | Responsibilitie s:Perform testing of raw materials, intermediates and final products by following analytical methods: Cell based bioassays, Flow Cytometry, ELISA and qPCR assay s.Work with internal and external resources to maintain lab in an optimal stat e.Assist with monitoring and trending data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Supply information to support generation of CoAs for product releas e.Maintains laboratory instruments for calibration and routine maintenan ceAuthor or revise SOPs, qualification/validation protocols and report s.Asist with lab investigations regarding out of specifications (OOS) results. Participate in determination of root cause for deviations related to analytical procedures. ?Provide updates at daily and weekly meeting s.Monitor the GMP systems currently in place to ensure compliance with documented policie s.Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriat e.Gather metric information for use in continuous improvement of areas of responsibilit #J-18808-Ljbffr