Job Details

Job DescriptionJob Description

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 aQC/QA Managerwith a biotech company inAnaheim, CAwho 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...@simplybiotech.comor call 858.###.####

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 .
• 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 .
• 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...@simplybiotech.comor call 858.###.####. More information can be found atwww.simplybiotech.com