QUALITY SPECIALIST III - CHANGE CONTROL - Johnson & Johnson (Los Angeles, California) in Los Angeles, California For Sale

Johnson & Johnson Consumer Group of Companies is seeking a Quality Assurance Specialist III – Change Control located in Los Angeles, CA.Â
 
Johnson & Johnson Consumer Group of Companies develops and markets consumer healthcare, baby care, and beauty/skin care products that address the needs of consumers and health care professionals and incorporate the latest innovations. The portfolio includes heritage brand JOHNSON’S® Baby and leading skin care brands such as NEUTROGENA®, AVEENO®, CLEAN & CLEAR® and LUBRIDERM®.
 
The Quality Assurance Specialist III is responsible for supporting identified aspects of compliance related to products manufactured at the Los Angeles Plant. This position is responsible for the site administration of the Global Change Control application and program ensuring the change request program is well-defined, executable, meeting customer and business needs, and in compliance with regulatory, sector, and franchise requirements. Proactively examines systems, processes, and standards to identify areas for review, change, or elimination.
 
This individual is responsible for establishing linkages to other key quality systems/programs such as APR/ADPR and Technology Transfer, Validation, Test Method Transfer, Production & Process Controls, Calibration, Preventive Maintenance, etc. Adheres to environmental and safety policies and procedures and supports department’s safety and environmental objectives.
This individual will:
Function as a quality lead on multi-functional teams in matters related to change control management.
Provide working knowledge of cGMP requirements and current FDA enforcement issues.
Demonstrate ability to collaborate with internal/external partners to enhance relationships and interactions, including interfacing with management to inform, drive change, and provide direct feedback.
Demonstrate ability to accomplish work goals, with a modest amount of daily direction and oversight.
Knowledgeable in quality assurance processes, procedures, and activities. Remain current on assigned quality system training.
Provide detailed or summary communication to QA management on status of key initiatives and issues.
Document investigations and rationales which are technically accurate and regulatory compliance focused. Most documentation (including site owned investigations) is first-pass approvable by QA Managers.
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 safety, quality and compliance improvement programs and initiatives. Innovate solutions to minor quality system gaps and participate in continuous improvement projects.
Guide decision making regarding product disposition and compliance decisions with moderate potential impact to customer service.
Participate in regulatory inspections, acting as a key support in back room operation Participates in regulatory inspections, acting as a key support in back room operation.
Represent Quality Assurance function on multiple, simultaneous, selected projects, as the “Voice of Qualityâ€, 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.
Support assessment and documentation of issues that might pose compliance risks, supporting investigation and solutions, and actions.
Responsible for revising established processes and procedures which may impact multiple functions or regions
Qualifications
Bachelor degree in science/chemistry or related fields
 Must have a minimum of 5 years of GMP experience (or 3 years of experience in a QA role, with plant QA experience preferred) in either Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements Production required
Strong communication skills, verbal and written are required.Â
Strong proficiency in Microsoft Office applications is required. The ability to manage complexity in a cross-functional matrixed environment is required. The ability to work independently with minimal supervision is required.  
Experience with Change Management and CAPA is preferred.Â
Quality and operations systems and processes experience is required.Â
Statistical Methods and Root Cause Analysis/Failure Investigation experience is preferred.
Excellent communication, interpersonal, conflict management, and organization skills are required. Strong leadership and coaching skills are required.
 
 
 
Primary Location
United States-California-Los Angeles
Organization
J & J Consumer Inc. (xxxx)
Job Function
Quality Assurance
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