QA/QC Manager - 21381

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 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 zrandel@simplybiotech.com or call 858.366.4951    
        

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 zrandel@simplybiotech.com or call 858.366.4951. More information can be found at www.simplybiotech.com   

Company DescriptionTalentZok was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2022, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, TalentZok is expanding to new markets and hiring additional staff in existing offices.Company DescriptionTalentZok was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2022, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, TalentZok is expanding to new markets and hiring additional staff in existing offices.