QC / QA Manager- Simply Biotech OVERVIEW Are you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below. Immediate opening for a QC / QA Manager with a biotech company in Anaheim, CA who possesses : - Minimum 5-7 years of progressive experience in Quality Assurance / Quality Control, with at least 3 years in a managerial role. MUST be able to show strong leadership experience.- Experience in a cGMP-compliant environment; personal care, cosmetics, or OTC manufacturing experience and Deep understanding of FDA regulations (21 CFR 210 / 211), ISO 22716 (GMP for cosmetics), and related quality standards.- Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or a related technical field. Email resumes to yorozco@ FULL DESCRIPTION : The selected candidate will be responsible for : - Lead the QA and QC teams, including training, development, and performance- management.- Develop, implement, and maintain a robust Quality Management System in compliance with GMP, FDA, ISO 22716, and customer standards.- Oversee all quality-related activities, including raw material testing, in-process checks, customer component AQL, finished goods inspection, and batch record review.- Investigate and resolve quality issues including non-conformances, deviations, customer complaints, CAPAs, and root cause analyses.- Ensure timely review and approval of production and laboratory documentation to support product release.- Manage internal audits, coordinate external audits (including customer and regulatory), and ensure timely resolution of findings.- Partner with R&D, Regulatory, Production, and Supply Chain to support product development, scale-up, and commercialization.- Maintain and report quality metrics (KPIs) and drive continuous improvement initiatives.- Ensure calibration and maintenance of lab equipment and oversee environmental monitoring and cleaning validation, if applicable.- Stay current with changes in regulatory requirements and ensure company compliance. The selected candidate will also possess : - Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or a related technical field.- Minimum 5-7 years of progressive experience in Quality Assurance / Quality Control, with at least 3 years in a managerial role.- Experience in a cGMP-compliant environment; personal care, cosmetics, or OTC manufacturing experience strongly preferred.- Deep understanding of FDA regulations (21 CFR 210 / 211), ISO 22716 (GMP for cosmetics), and related quality standards.- Strong leadership, problem-solving, and communication skills.- Experience with QMS platforms, LIMS, and document control systems preferred.- Ability to manage multiple priorities and thrive in a fast-paced, deadline-driven environment. Salary Range : $100k-$120k / yr For immediate and confidential consideration, please email your resume to yorozco@
Manager • Anaheim, CA, US