Quality Specialist

Ridgefield, NJ

Posted: 04/24/2019 Industry: Manufacturing/Production/Operations Job Number: 48730

The 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.

Reviews 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-conformance' s containment tasks using the TrackWise and SAP system.

Skills: Experience writing/reviewing SOPs Able to navigate various computer platforms (LiveLink, StarLIMs, SAP and TrackWise) Education: Bachelor' s degree in scientific discipline or equivalent 1-3 years experience

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

Lara Coghlan

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