Quality Specialist

Ridgefield, NJ

Posted: 05/08/2019 Industry: Quality Assurance/Safety Job Number: 48812

Shifts:

2nd shift (3pm-11pm) &3rd shift (11pm -7am)

The QACompliance 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.

Drafts and reviews specifications and SOPs. Monitors and trends batch record errors and assists Quality Assurance management with metrics.

Assist Departments with Packaging process improvement projects.

Provide Quality Investigation Group with BPRs and QC data to support Deviations and Customers complaints investigation closure. Perform Real time Batch record review and release

Deal with Supplier issues as needed using SAP to run genealogy reports.

Perform Line clearances and support packaging activities.

Familiar with AQL sampling, normal, reduced, and tightened inspections and switching rules.

Maintain and complete non-conformances containment tasksusing the Track Wise and SAP system. Able to navigate various computer platforms (Live Link, StarLiMs, SAP and Track Wise) Overtime as necessary

Skills: Experiencewriting/reviewingSOPs/Investigations Able to navigate various computer platforms (LiveLink, StarLIMs, SAP and TrackWise) Manual visual inspection is also required of this role

Education: Bachelor' s degree 1-4years 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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