Quality Engineer III - Montgomery (Elizabeth)

Compensation

: $96,150.00 - $135,490.00 /year *

Employment Type

: Full-Time

Industry

: Engineering



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The Quality Engineer III position provides overall Quality Assurance leadership in the management of contract manufacturing sites engaged in the production of topical OTC drugs, medical devices, combination products, nutritionals, NDA's, and/or cosmetic formulations for J&J Consumer as well as Trade Customization Sites and Affiliates.
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A Quality Engineer III is responsible for supporting Contract Manufacturing, sites Trade Customization Sites and Affiliates by driving compliance & quality improvement initiatives, assisting resolution of process/product non-conformance events, monitoring/resolving complaints, reviewing Annual Drug Product Review reports reporting Contract Manufacturer performance metrics and interfacing with J&J business partners.
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This job position may represent QA on project and improvement teams by guiding setting quality/compliance requirements, development of SOP's & specifications, and providing technical transfer/validation support.

-Knowledgeable in quality assurance processes, procedures, and activities. Remain current on assigned quality system training.
-Provide detailed or summary communication to QA Directors and Managers on status of key initiatives and issues.
-Document rationales which are technically accurate and regulatory compliance focused for product disposition, risk assessment/mitigation, non-conformances, corrective actions, and audit observation responses. Hold business partners accountable for delivering documentation of similar quality.
-Conduct, execute and document thorough investigations and CAPAs. Ensure timeliness of deliverables through proactive intervention. May own CAPA action items or deliverables.
-Troubleshoot quality/compliance issues, using experience, ingenuity, and creativity to provide solutions to a wide range of root causes.
-Implement quality and compliance improvement programs and initiatives. Innovate solutions to minor quality system gaps and participate in continuous improvement projects.
-Represent NA Source Quality on multiple, simultaneous, selected projects, as the "Voice of Quality", including active team engagement, proactively ensuring quality and compliance inputs are integrated into the project deliverables, and act as a QA "go-to" resource for cross-functional business partners.
-With a modest amount of daily direction and oversight from manager, prioritize highly complex and diverse workload ensuring deliverables are on-time, accurate, and meet their intended objective.
-Independent and guided decision making authority and accountability for product disposition and compliance decisions with medium to significant potential impact to customer service
-Review and approve compliance records, specifications, procedures, new product introduction development plans, and other documents, as required by procedure.
-Responsible for revising established processes and procedures which may impact multiple functions or regions.

Drive closure of MAPs, through holistic and comprehensive engagement and negotiation with EM.
Associated topics: business, cost efficient, industrial engineer, manufacturing engineer, methods engineer, project, sap, supply, supply chain * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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