STAFF QUALITY ENGINEER-MICROBIOLOGY-0311130129
Description
Neutrogena, a member of the Johnson & Johnson Family of Companies, is recruiting for a QA Staff Quality Engineer, Microbiology, located in Los Angeles, CA.
Neutrogena Corporation develops, manufactures and markets premium skin and hair care products sold worldwide and recommended by medical professionals. The regulatory classification of the products is principally OTC drug. The product line includes acne treatment products, sun protection, facial care as well as other hair and skin care products.
The QA Staff Qualify Engineer, Microbiology, is accountable for providing microbiological guidance, support, and technical support to the Johnson & Johnson Consumer Los Angeles manufacturing and packaging operations. This individual will support activities related to hygienic equipment design, operating practices and cleaning and sanitization processes.
This individual will develop systems to proactively define potential area of microbial risk in equipment design, maintenance, materials, manufacturing, packaging processes, and cleaning & sanitization.
The QA Staff Quality Engineer drives the development of the organization hygienic implementation strategies, goals, and objectives in accordance with J&J standards to assure that all products meet company and regulatory microbiological standards. Trains and provides oversight to internal and external business partners on the fundamentals and microbiological controls to prevent and eliminate microbial contamination during production.
This individual will work closely with the Plant QA Microbiology team and Plant QA team to implement continuous mitigation and improvement programs across all areas of the Plant, oversee new process, equipment and products to identify and eliminate microbial risks. This individual will be responsible for training personnel at all functions in the development, manufacture, and storage of liquids products to prevent microbial contamination at each stage of the production process. This individual will provide technical expertise to colleagues regarding the interpretation and/or implementation of cGMP hygienic practices.
The Staff Quality Engineer will assure best practices and systems are utilized for Raw material sampling, pre-weigh of chemicals, compounding/production, and packaging. In addition, this individual will ensure systems and practices are in compliance with the J&J consumer Hygienic practices and correctly implemented and controlled.
This individual will establish, revise, and modify SOPs to reduce microbiological risk within the production environment. This individual will conduct hygienic practice audits of the test laboratory and production environment. The Staff Quality Engineer will help troubleshoot equipment and methodologies, communicate microbiological risk to customers and conduct Micro robustness reviews.
This individual will lead and drive investigations of micro failures to ensure true root cause is identified and documented with the Quality System to ensure compliance and corrective and preventative actions have been effective.
This individual will maintain knowledge of the current regulatory environment, cGMPs, FDA policies and current industry trends to keep up to date on hygienic practices for site inspections and provide direction and leadership to assure compliance with quality regulations. This individual will provide reports, trend analysis, or feedback to inform management of quality trends and to establish appropriate corrective actions. This individual will provide technical support to the new product introduction process, including review of material and finished product microbiological risk classifications, equipment train readiness, including review. Assists management as a professional advisor and authoritative figure on issues pertaining to specialized and detailed microbiological tasks and issues.
Qualifications
A minimum of a Bachelor&'s degree in Microbiology, Biology, Engineering or closely related field is required. This position requires a minimum of 5+ years of work experience is required. Experience in a GMP FDA regulated facility manufacturing consumer or pharmaceutical products is required. Experience in conducting, executing, and leading microbiological investigations is preferred. Experience in plant Microbiology, process equipment design, environmental monitoring, cleaning and sanitization are preferred.
Experience developing and implementing mitigation and improvement programs is preferred. Experience in training and influencing employees is required. Experience leading investigations is preferred.
Experience writing, revising, and modifying SOPs is required. Broad-based experience or combination of experience in microbiological control in a production facility, HACCP, consumer/pharmaceutical manufacturing, facility/utility engineering, microbiology laboratory operations, quality operations, and regulatory compliance is preferred.
Significant knowledge of Microbial Quality Assurance in Toiletries, Cosmetics, and Non-sterile pharmaceuticals is required. Strong knowledge of CFR 210,211 is preferred. Experience with partnering and influencing across business operations (Production Planning, Operations, Suppliers, Technical Assurance, Procurement, and R&D) is preferred.
This position requires collaborative conjunction with management to develop or improve methodologies and/or processes. This individual will be able to understand process criteria and regulations and business impact of decisions and actions. Strong attention to detail and sense of urgency are also required. Ability to work independently with little guidance is required.
This candidate will be able to influence people at different levels in a matrix organization. Strong independent and analytical thinking skills are required. Demonstrates the ability to communicate effectively with upper management on microbiological issues is required.
Position may require up to 10% overall travel.
This position is located in Los Angeles, California and requires the candidate to work a professional work schedule.
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Primary Location:North America-United States-California-Los Angeles
Organization: Neutrogena Corporation (6107)
Job: Quality (Eng)
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