NJ Employer QA Associate - Product Release, GMP (856973) in Ridgefield, New Jersey

DescriptionThe QA Product Release Associate is responsible for ensuring the safety, efficacy, purity, and quality of manufactured products through compliance with cGMPs, regulations and established procedures. They support the review of batch records, assemble and review batch files, support the completion of the annual product review, maintain and utilize Quality Assurance databases, utilize the SAP System, review documentation for compliance with cGMPs, FDA, ICH and other regulatory requirements and perform administrative tasks.DutiesReviews manufacturing BPR (batch production records) to ensure compliance with internal specifications and cGMPs.Assures documentation is in compliance with cGMP regulations and ISO 13485 guidelines.Compiles device history record (DHR) for medical lots in preparation for product release.Drafts and reviews specifications and SOPs.Monitors and trends batch record errors and provides Quality Assurance management with metrics.Draft and provide Quarterly Metrics/ Yearly Metrics to Quality Assurance Management.Assist Departments with Process Improvement Projects.Provide Quality Investigation Group with BPRs and QC data to support Deviations closure.Perform Batch record closure and Product disposition.Maintain and complete non-conformances containment tasks using the TrackWise and SAP system.SkillsExperience writing/reviewing SOPsAble to navigate various computer platforms (LiveLink, StarLIMs, SAP and TrackWise)EducationBachelor's degree in scientific discipline or equivalent 1-3 years experienceEEO EmployerApex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.VEVRAA Federal ContractorWe request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available here. https://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf