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@simplybiotech.com or call 858.496.7758
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@simplybiotech.com or call 858.496.7758. More information can be found at www.simplybiotech.com
Job Type: Full-time
Pay: $100,000.00 - $120,000.00 per year
Work Location: In perso