Quality Assurance Manager - NeoLife
Hayward, CA 94545
About the Job
NeoLife is a nutrition company that has been in business for 65 years and operating in over 50 countries around the world. We offer superior quality products using nature's finest whole food ingredients that are based in nature and backed by leading edge science. We are on a mission to make the world a healthier and happier place. We believe that because people matter, health and wellness should matter.
This position is in our Natural Formulas Manufacturing Division which is located in Hayward, California.
POSITION SUMMARY:
Develops, implements, and coordinates the company's product quality assurance program to prevent or eliminate defects in new or existing products including audit, validation programs, review and sign off on all deviations.
JOB RESPONSIBILITIES:
- Company contact with regard to outside audits and regulatory audits.
- Initial contact for product quality complaints. Answer production-related technical questions for production, management, and international clients and suppliers.
- Auditing of Natural Formulas facility and suppliers for GMP compliance. Assist in the development and completion of procedures to ensure production compliance with GMP and FDA guidelines.
- Responsible for issuing deviations for any process, product or packaging including all deviation risk assessments.
- Coordinate mock product recalls.
- Participate in Natural Formulas Process Validation program.
- Participate in Natural Formulas Change Control program.
- Review manufacturing procedures to develop guidelines, procedures, and improve review criteria to maximize quality levels for finished product.
- Training, scheduling and supervision of all Quality Assurance personnel.
- Confer with Product Development for product improvement and rework, including review of PQR.
- Collaborate with Product, Science, and Technology team on any raw material changes.
- MRP system release and reject ability.
- Develop and maintain controlled filing systems for company documents that meet corporate, legal and regulatory (GMP) requirements.
- Implement document retention systems and disposal schedules.
- Ensure document and records security and enable appropriate access to documents and records.
- Conduct audits of Natural Formulas document control system to ensure security, efficiency and regulatory compliance.
- Communicate with production management regarding any issues or problems.
- Act as management backup in the absence of the Quality Control Manager.
- Assist in the training of leadership on monthly/annual GMP topics.
JOB REQUIREMENTS:
- Bachelor of Science Degree in chemistry, biochemistry, biochemical engineering, life science, or related field.
- 3-4 years or more of Quality Management experience in FDA regulated manufacturing environment.
- Familiar with raw material and finished good specs for dietary supplements.
- Understanding and knowledge of dietary supplement cGMPs, 21 CFR part 111.
- Experience with Good Manufacturing Practices (GMP's) required.
- Skilled and strategic manager, strong technical and analytical skills.
- Attention to detail, critical-thinking skills, superior organizational skills.
- Strong leadership abilities to motivate and train.
- Effective communication skills both verbal and written.
- Proficiency in Microsoft Office Suite of applications (Word, Excel, Outlook).
- Ability to lift/move 25 lbs routinely.
To Apply:
Please submit your resume and salary requirements for consideration. All candidates must have legal authorization to work in the United States without visa or employer sponsorship. NeoLife offers a comprehensive benefit program including medical, dental, and vision insurance, 401k retirement plan, health care & dependent care flexible spending accounts, life insurance, and other great benefits! Please visit our website at www.neolife.com to learn more about us!
PI248713757
Source : NeoLife
