QA/QC & Regulatory Manager

Sun Bum

Encinitas California

5 year(s)

Job Description
• The QA/QC & Document Control 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:
o Maintaining documents and information in our formulation software
Required Skills / Experience / Competencies:
• 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

Preferred Skills / Experience / Competencies:
• 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