QA/QC & Regulatory Manager
- 444 S Coast Hwy 101, Encinitas, CA 92024, USA
In 2010, we started making sun care products to protect ourselves, our families and our friends from the damaging rays of the sun. Since then, we’ve grown and expanded into hair care and lip care products, and even launched Baby Bum, our rad new plant-based baby skin care line. Along the way, we’ve been building an amazing like-minded global community of friends that encourage us and help us be better. Today, we are looking for a few more talented and passionate people to join our crew – not for the money or the amazing location to live and work, but for the opportunity to change the world a little with us.
- The QA/QC & Regulatory Manager is to ensure that records are established and maintained to provide evidence that the Quality Management System is being followed and that there is a system in place for the identification, storage, protection, retrieval, retention time and disposition of such records.
- Ensure that processes and SOPs needed for the Quality Management System (QMS) and 21 CFR are established, implemented and maintained.
- Ensure that document control procedures are created, approved and adopted. Review and update all changes to critical documents within the scope of the Quality Management System.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Ensure that product review and release procedures are adopted to approve, review and release all finished goods at Sun Bum LLC
- Ensure that all suppliers used by the organization are selected, evaluated and reevaluated and that records of this assessment are maintained
- Artwork review and approvals
- Lifestyle products testing and monitoring compliance.
- Issue CAPA and investigate into defects and rejections
- Create INCI, COA, Specs, SDS etc for new products.
- FDA registration for new and reformed products for NDC numbers for SB and manufacturers.
- Monitor product compliance with FDA and other regulatory body.
- Keep Master Dossier up to date with all records
- International registration documentation – EU, UAE, DR, Chile, Costa Rica etc.
- Assist Product Development/R&D on new projects and backup as needed.
- EU registration (lifestyle & products) via Biorius and BV
- Assist with:
- Maintaining documents and information in our formulation software
- Other duties as assigned
- Bachelor Degree in a science related field (Biology, Chemistry)
- 5+ years’ quality management experience
- ASQ (American Society of Quality) Certification Preferred (Six Sigma Black Belt).
- Active knowledge of GMP/GLP/GXP and FDA 21 CFR Requirements
- Excellent analytical and problem-solving skills
- Impeccable communication, presentation and organizational skills
- Thorough knowledge of methodologies of quality assurance and standards
- Excellent numerical skills and understanding of data analysis/statistical methods
- Good knowledge of MS Office and databases
- Great attention to detail and a result driven approach
- Reliable and Trustworthy
This role is full time and includes medical benefits, vacation, sick time, paid holiday, 401k, FSA and the like.
Compensation will depend on experience.