Staff Quality Engineer-5130121212
Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies Inc. is currently recruiting for a Staff Quality Engineer located in Skillman, NJ.
Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. develops and markets baby care, wound care and skin care products that address the needs of consumers and health care professionals and incorporate the latest innovations. The portfolio includes heritage brands JOHNSON'S® Baby and BAND-AID® Brand, as well as leading skin care brands such as AVEENO® and CLEAN & CLEAR®.
The Staff Quality Engineer supports North America Supplier Quality Management, for raw materials, components and packaging materials used to manufacture finished goods. This individual executes the Quality strategy to ensure compliant systems and procedures are in place at J&J and material supplier sites. This individual is responsible for conducting and managing new and existing supplier assessments to determine the state of Quality Systems, GMPs and Process Capabilities in support of ongoing business and new product introductions, to ensure that supplier systems are aligned with current regulatory requirements, standards, industry trends, and J&J policies and standards. This individual is also responsible for providing oversight for material supplier assessments and outcomes across all of North America for Skincare and Consumer Healthcare Franchises. The position reports to the Manager of QA, North America Supplier Quality Management.
The Staff Quality Engineer will drive execution of the Quality strategy for supplier assessments, develop and execute annual supplier assessment plan and conduct supplier site assessments and/or oversees supplier assessments which are conducted by authorized third party contractor. This individual will participate in pre-assessment meetings with assessment team, including ensuring the compilation of appropriate pre-assessment information, documentation and supplier performance trends. This individual will participate in post-assessment briefings, provide technical expertise to ensure that quality systems are achieved, and assess current Quality systems and recommends improvements. The Staff Quality Engineer will communicate Quality systems' compliance risk, write, review and execute documents and procedures and participate in investigations or for-cause supplier site-audits. This individual will monitor, trend, identify issues, and drive the resolution of supplier quality issues while supporting the execution and negotiation of Supplier Quality Responsibility Agreements.
A minimum of a Bachelors degree is required. A focused degree in chemistry, microbiology, or science discipline is required. A minimum of 7 years of experience in a Quality Assurance role within a Pharmaceutical, Medical Device & Diagnostic, and/or OTC Drug industry environment is required. Direct experience in plant and/or supplier GMP auditing is required. Prior manufacturing, plant or technical background is required. An understanding of Drug cGMP's, Quality System Regulations, ICH Q7 and IPEC-PQG GMP guidelines is required. Broad experience with quality systems, including but not limited to validation, non-conformance, CAPA systems and investigations, laboratory controls, production and process controls, is required. Experience with documentation and technical writing skills, in a regulated compliance environment, is required. Quality Auditor or Lead Auditor certification is preferred. Prior experience with FDA inspections is desirable. Experience with Six Sigma Process Excellence tools, training and/or certification is desirable.
In-depth knowledge of Supplier Quality Management principles, expert auditing and problem solving skills, in-depth knowledge of Quality and operations systems and processes is required. Demonstrated ability to translate GMP requirements into SOPs and specifications, understanding of GMPs as they pertain to manufacturing, testing and packaging of drug products, and demonstrated ability to identify compliance risks and assess business impact, are required. Demonstrated ability to develop and implement Quality standards is desirable. Excellent written and oral communication and interpersonal relationship skills across all levels are required.
This position may require up to 40% travel domestically and internationally and will be based in Skillman, NJ.
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Primary Location: North America-United States-New Jersey-Skillman
Organization: Johnson & Johnson Consumer Inc. (6071)
Johnson & Johnson Family of Companies - 2 years ago
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