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Job #02550

About our client Our client is a leader in drug delivery systems. The company’s expertise is in parenterals. The company is internationally recognized for its contributions to the drug delivery field since its early days of controlled release in 1970s and still has a market-leading share in its field of expertise. The company has many achievements to its credits, including 20+ drug-delivery patents, formulation and product development, etc. The company has worked with virtually all drug classes, including small molecules, peptides, proteins, nucleic acids and cell fragments. Position Location Quality Assurance Manager Alabama Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage environmental monitoring program for sterile manufacturing clean-room suites 2) Review and approve the facilities and equipment along with the qualification and process validation protocols and summary reports 3) Manage the change control program for significant changes in facilities, equipment, procedures and methods 4) Review and approve analytical methods, standards and specifications 5) Track quality assurance and prepare reports of performance metric trends for the management oversight Requirements 1) B.S. degree in Physical or Biological Science (Microbiology preferred) 2) 3+ years of experience in quality assurance/quality control in the pharmaceutical or medical device industry 3) Knowledge of and experience in cGMP requirements for drugs and medical devices 4) Strong organizational skills