Senior Quality Assurance Specialist – GMP & ISO

bmsc-careers; Fort Worth (TX); On-site; USD 65,000 - 100,000; Full time

Job summary

bmsc-careers in Fort Worth, TX is seeking a Quality Specialist III responsible for ensuring personal care products meet quality standards and regulatory requirements. You will develop and implement QA processes to ensure product safety and consistency.

Responsibilities include monitoring QC data, reviewing batch records for cGMP and SOP adherence, ensuring compliance with FDA and ISO standards, and maintaining documentation for audits. Strong analytical and communication skills are essential.

Qualifications

• Minimum 4 years of relevant industry experience.
• A 4-year degree in microbiology, chemistry, food science or related discipline.
• Proficiency with HPLC and ICP-MS.
• Knowledge of FDA, ISO, cGMP and 21 CFR regulations.

Responsibilities

• Monitor and analyze quality control data and test results.
• Review batch production records and verify adherence to cGMPs and SOPs.
• Ensure products comply with local, national, and international regulations (FDA and ISO).
• Prepare and maintain documentation required for regulatory compliance and audits.
• Maintain detailed records of testing results, deviations, and controlled information.
• Conduct root cause analysis and recommend corrective and preventive actions.
• Provide training to junior Quality Specialists on QMS.
• Support QA/QC manager as necessary.
• Perform additional duties as assigned.

Skills

Analytical thinking

Attention to detail

Strong communication

Education

Bachelors in microbiology, chemistry, or food science

Tools

HPLC

ICP-MS

Microsoft Office

Job description

bmsc-careers in Fort Worth, TX is seeking a Quality Specialist III responsible for ensuring personal care products meet quality standards and regulatory requirements. You will develop and implement QA processes to ensure product safety and consistency.

Responsibilities include monitoring QC data, reviewing batch records for cGMP and SOP adherence, ensuring compliance with FDA and ISO standards, and maintaining documentation for audits. Strong analytical and communication skills are essential.