Neutrogena Corporation, a member of Johnson & Johnson's Family of Companies, is recruiting for a Plant Quality Specialist III to be 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 Plant Quality Specialist III will:
•Directly support manufacturing operations in daily quality activities, investigations (INV), and overall quality direction and will support other related manufacturing operations as required.
•Use Process Excellence tools in INV and CAPA (Corrective and Preventative Actions) root cause investigations and determination of appropriate corrective and preventative actions.
•Support the technical evaluation, investigation, and closure of assigned consumer complaints to ensure full GMP compliance to QA responsibilities related to the consumer complaint process.
•Ensure complaint trends are routinely monitored, reported to management, escalated in a timely manner, and monitor compliance to the Complaint Vigilant Procedures.
•Facilitate continuous process improvements, and investigate quality problems associated with production and also maintain change management to keep systems under control.
•Be responsible for reviewing production documentation and executing SAP transactions to support the product release process.
•Develop standard operating procedures and specifications.
•Review, provide feedback, and approve Operations SOPs and forms as needed to support manufacturing.
•Provide data and documentation in support of investigations and modifications to procedures.
•Approve material hold verification, non-conformance initiation, and destruction verification for investigations.
•Work on continuous improvement projects to minimize sample and scrap waste, assess reliability and risks based on validated data, identify root causes of problems, and reduce or eliminate sources of variation.
•Lead the implementation and execution of quality improvement projects at the Los Angeles Plant including quality system improvement projects.
•Develop and assist teams, systems and resources necessary to provide fully tested and validated equipment, packaging, and processes meeting J&J and Regulatory quality and enforce policies, maintained across all elements of new product development, manufacturing, and distribution.
•Monitor quality and report on key quality metrics with key business partners such as Operations and SMP on finished good and bulk related non-conformances resolutions.
•Ensure quality related production processes and SOPs are current and FDA compliant.
•Be expected to cross-train in other areas of QA and serve as back-up QA support for all production areas, as necessary.
•Provide plant wide training and guidance on Quality and Compliance topics.
•Participate and support internal and external regulatory compliance audits.
•Conduct and/or support compliance audits and author or review compliance audit reports.
•Prepare and communicate/present report or other formal communication documentation for senior management review.
•Review production batch records for completeness and accuracy.
•Author, review, or approve manufacturing protocols, risk assessments, or other documentation as needed.
•Influence consistent compliance culture behaviors across the organization.
•Other duties as assigned.Qualifications
Requirements & Qualifications:
•A minimum of Bachelors or equivalent degree is required, preferably in STEM, or Business Administration discipline.
•A minimum of 3 years of GMP experience in Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements Production is required.
•A minimum of 1 year working in a GMP facility is preferred.
•Experience analyzing data for trend identification and/or process improvement opportunities strongly preferred.
•Ability to communicate thoughts and ideas effectively, both verbally and in writing and to explain technical material to nontechnical audiences is required.
•Ability to assist in preparation of detailed or summary communication on status of key initiatives and issues is required.
•Familiarity with basic quality tools and techniques is preferred.
•Ability to read, analyze, and interpret technical documents is required.
•This position is located in Los Angeles, CA and may require some travel.
Be VITAL in your career. Be seen for the TALENT you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.Primary Location
United States-California-Los AngelesOrganization
J & J Consumer Inc. (6101)Job Function