Quality Assurance Manager at Hightstown

Job Description

AppleOne is in need of a Quality Assurance Manager.BS in Chemistry, Biochemistry or related field with a minimum of 3 years of experience is a MUST.Skills Required:In-depth understanding of the cGMPs requirements for the various areas (processing, operations, quality control, and ICH guidelines) as well as experience on their applicationExperience in writing and reviewing documentation for process, operations and validationsHighly organized and able to manage multiple projectsExcellent written and oral communication skillsVersatile, autonomous and able to take ownership of projects Responsibilities:Manages documentation controlPrepares SOPs, department IOPs, quality related reports and change control documents (PdAs), when appropriateApproves IOPs of the various departmentsApproves process master documentationApproved product specifications and associated documentationFinal product releaseReviews completed batch records and associated deviationsPeriodic follow-up of ongoing deviations and PdAs to assure timely closure of documentation (recommended monthly follow upsApproves quality related and/or project specific protocolsResponsible for evaluation/approval of equipment cleaningApproves equipment qualification protocols and reportApproves process validation protocols and reportsManages site stability program including approval of stability dta reportsHandles Clients quality related issuesProvides guidance and support to the project team in Quality Assurance related activities;Assists the Head of Compliance to achieve the department objectives.Apply for this great position as a Quality Assurance Manager today! We are an equal employment opportunity employer.

Job Requirements

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Country: USA, State: New Jersey, City: Hightstown, Company: AppleOne.