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Senior QA Specialist, Biologics Operations

Company: Aerotek
Location: Gaithersburg
Posted on: April 9, 2021

Job Description:

Description:Our client a late-stage biotechnology company that promotes improved global health through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases is seeking an experience QA Specialist to oversee manufacturing operations at one of their contract manufacturers.Provides Quality Assurance oversight to external Contract Manufacturing Organizations to deliver deposition of all batches in a timely and compliant manner. Is responsible for ensuring consistency of approach to management of CMO's, and for ensuring are in compliance with the regulatory requirements for their respective countries.This role will partner closely with Manufacturing, QC, Validation, Regulatory, Site compliance lead to manage CMO's to ensure timely disposition and issue management . Strong collaboration and the ability to effectively work in a matrixed environment is critical to successSkills:Quality assurance, Gmp, Batch record, manufacturing quality, Biologics, Fda, Audit, Capa, Qa, Cgmp, Sop, Process Transfer, Scale Up, Validation, Batch record review, Investigation, Deviation, Drug SubstanceTop Skills Details:Manufacturing QualityBiologicsDrug SubstanceBatch Record ReviewAdditional Skills & Qualifications:Education & Experience RequirementsMinimum Bachelor's degree in pharmacy, chemistry, biology or a related discipline.Minimum 8-10 years' experience working in a Quality role in the pharmaceutical industry.Experience in the biotechnology and/or pharmaceutical industry, preferably bothExperience in CMO operations, manufacturing preferredThorough understanding of quality systems, cGMPs, GDPs.Experience with Aseptic/ Sterile Processing and Biological DS manufacturing.Experience leading, training and/or implementing root cause analysis and effective investigation practices; CAPAHigh level of professional competence and confidence in leading teamsExperience Level:Expert Level About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, Washington DC , Senior QA Specialist, Biologics Operations, Other , Gaithersburg, DC

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