QUALITY ENGINEER II-1547121203
Neutrogena, a member of the Johnson & Johnson Family of Companies, is recruiting for a Quality Engineer II, 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 product line includes bar and liquid cleansers, shampoo, hand cream, body lotion, facial moisturizers, sun protection and cosmetics, as well as other hair and skin care products recommended, used and prescribed by dermatologists.
The Quality Engineer II is responsible for ensuring batch records meet current Good Manufacturing Practice (cGMP) and J&J standard operating procedures. Develop Annual Drug Product Review (ADRP )schedule, coordinates data collection and compiles the ADPR report for management review and approval. Supports the executing of internal audit program and issues weekly escalation summary reports to Senior Management. Provides support in with compliance related activities in achievement of Los Angele Plant's standards for quality.
The Quality Engineer II with Johnson and Johnson policies, procedures, and quality standards, as well as safety and environmental regulations. The Quality Engineer II will completes monthly batch record review audits, issues report and drives corrective action plan and closure. He or she also develops the annual ADPR schedule and distributes it to applicable functional areas. The Quality Engineer II coordinates data collection, writes ADPR reports, and submits for review and approval to QA management, as well as responsibility for generating routine/escalation management communications on a weekly basis. The Quality Engineer II will support cGMP and Compliance Training, compliance activities including Quality Agreements and Site License registration renewals, and will support the execution of the internal audit program activities including corrective action status tracking, reporting, and scheduling.
The Quality Engineer II also completes quarterly Site Quality Management reviews, Tracks the local LAP standard operating procedures review period and issue periodic reports to management, and supports compliance audit readiness action planning as needed. Additionally, the Quality Engineer II is responsible for the review, trending, analysis, and reporting data independently; recommends appropriate actions, as well as any other activities as specified by reporting supervisor or manager. Additionally, the Quality Engineer II will be responsible for adequately understanding and utilizing computer systems in analyses, cross-training in other QS&C areas, and may be required to take a role in FDA and Corporate Quality Inspections to help support LAP quality systems withstand regulatory scrutiny
A minimum of a Bachelor's degree in science, engineering or related discipline from a four-year college or university; or equivalent combination of education and experience. A minimum of 3-year work experience in a quality and/or compliance environment is required. Experience working in a highly regulated GMP healthcare industry (pharmaceutical, medical device and diagnostic, and/or OTC industry), is required. A working knowledge of the regulatory requirements and guidelines is required. A strong project management and process excellence skills to manage projects determine and assign priorities. Excellent written/oral communication and interpersonal relationship skills. Ability to influence, negotiate and lead without direct line authority. Ability to manage complexity, and diverse teams. Ability to think critically and be detail-oriented while overseeing multiple tasks for several projects or base business deliverables.
The ability to work in Los Angeles, CA is required.
Approximately 10% domestic travel may be required
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Primary Location: North America-United States-California-Los Angeles
Organization: Neutrogena Corporation (6107)
Johnson & Johnson Family of Companies - 18 months ago
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