Johnson & Johnson Careers
Senior Manager Quality Assurance
Requisition ID: 9239190312
Zarbee’s Naturals, a member of the Johnson & Johnson Family of Companies, is currently seeking a Senior Manager Quality Assurance located in Draper, Utah.
Johnson & Johnson Consumer Inc., based in Skillman, N.J., is one of the world's largest consumer health and personal care products company. Our consumer companies produce many of the world's most trusted brands, among them JOHNSON'S® Baby, BAND-AID®, NEUTROGENA®, TYLENOL®, MOTRIN®, and LISTERINE®. Each one of our consumer businesses embraces innovative science to create products that anticipate consumer needs and create experiences that help them live healthy, vibrant lives.
Zarbee’s Naturals has evolved from a pediatrician founded brand of children’s cough syrups to a leading brand of health & wellness products for the whole family. Zarbee’s uses wholesome, handpicked ingredients whenever possible and was the first to develop more natural, clinically proven over the counter products that help keep the whole family healthy and happy.
The Senior Manager Quality Assurance ensures that external manufactures of Zarbee’s products meet necessary quality standards as outlined in 21 CFR 111 and 21 CFR 117.
• Develop and implement product specifications and standard operating procedures (SOPs):
-Provide ongoing support by helping to create new documents, reviewing and revising existing documents, and verifying that the documents are aligned with relevant regulations.
-Review protocols (stability), summary reports (customer complaints), SOPs, and internal specifications to ensure that documentation is accurate and complete.
-Provide final approval and sign-off on customer complaints, SOP’s, and internal specifications.
-Create CCR’s as appropriate and support entry into the document management system.
• Help to establish stability testing programs with R&D and participating manufacturers and ensure ongoing compliance
-Provide document support to Document Control Specialist
• Follow cGMP practices, policies and procedures.
-Provide training as required.
• Perform record reviews of batches supplied by co-manufactures.
-Sign-off on product release as required by 21 CFR 111.
-Approve documentation for ensuring dietary supplements meeting identity, strength, purity and composition.
• Review documents, assess risk and create GAP analysis based on current FDA regulations.
-Help with the development of programs to eliminate or reduce risks as identified in GAP analysis.
• Help to maintain electronic document management system and ensure documents are current.
-Participate or lead internal quality reviews of documentation, training records, stability programs, CAPA’s
• Investigate and resolve product and process problems related to quality issues.
-Participate in investigations of customer complaints; working with manufactures and operations to resolution.
-Ensure CAPA’s are properly documented and corrective actions taken
• Prepare and give technical presentations as required.
• Maintain company quality assurance archives.
• Review company labels and literature for technical accuracy and regulatory compliance.
• Understand and adhere to GMP policies and Procedures.
• Provide ongoing technical assistance and problem solving with existing manufacturers and suppliers, leveraging industry experiences and best practices.
• Lead the process for gaining and maintaining compliance US regulatory agencies as necessary
• Participate in communication with the FDA or other regulatory agencies as needed
• Perform other duties as assigned or needed.
• Bachelor’s degree required. Concetration in biology, biochemistry, nutrition, food science, or related science field is highly preferred.
• Minimum 8 years’ experience in a manufacturing environment (Pharmaceutical, Dietary Supplements or Food) with Good Manufacturing Practices (GMP) required.
• Minimum of 3 years’ experience working in close support with R&D, Operations and Quality required.
• Audit experience required.
• Previous experience writing and reviewing with understanding SOPs and specifications required.
• People management experience (direct reports) highly preferred.
• Strong written and oral communication skills required.
• Travel ~30% within North America (US & Canada) with potential for International
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.