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Now viewing: Quality Assurance Manager
KI
KeyStaff, Inc.
Quality Assurance Manager
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Job Description
Quality Assurance Manager Quality Assurance Manager
Location:
Miramar, FL
Salary:
$120,000 - $130,000 annually
Position Summary
We are seeking an experienced Quality Assurance Manager to lead the Quality department within a pharmaceutical manufacturing facility in Miramar, FL. This position is responsible for ensuring compliance with FDA regulations, cGMP requirements, company quality standards, and all applicable regulatory guidelines. The Quality Assurance Manager will oversee quality systems, audits, investigations, and continuous improvement initiatives while partnering with cross-functional teams to maintain the highest standards of product quality and patient safety.
Key Responsibilities
Manage and oversee all Quality Assurance activities within the pharmaceutical manufacturing facility.
Ensure compliance with current Good Manufacturing Practices (cGMP), FDA regulations (21 CFR Parts 210 & 211), and company quality standards.
Maintain and improve the Quality Management System (QMS), including SOPs, change controls, deviations, CAPAs, and document control.
Lead internal, customer, and regulatory audits, including FDA inspections, and ensure timely responses to audit findings.
Review and approve batch records, investigations, deviations, change controls, validation protocols, and quality documentation.
Conduct root cause investigations and implement effective Corrective and Preventive Actions (CAPA).
Monitor quality metrics and prepare reports for executive management.
Partner with Manufacturing, Validation, Regulatory Affairs, Engineering, and Supply Chain to drive continuous quality improvements.
Ensure products consistently meet established quality standards before release.
Manage supplier quality programs, qualification activities, and vendor audits.
Train and mentor Quality Assurance personnel while promoting a strong culture of quality and compliance.
Support process validation, equipment qualification, and risk management initiatives.
Ensure inspection readiness and maintain compliance with all regulatory requirements.
Qualifications
Bachelor's degree in Biology, Chemistry, Pharmaceutical Sciences, Engineering, or a related scientific field.
Minimum of 5 years of Quality Assurance leadership experience in a pharmaceutical manufacturing environment.
Extensive knowledge of FDA regulations, c
GMP, ICH
guidelines, and pharmaceutical quality systems.
Experience managing CAPAs, deviations, change controls, document control, and internal/external audits.
Strong understanding of validation, risk assessment, and quality management principles.
Proven leadership experience managing and developing Quality teams.
Excellent analytical, problem-solving, communication, and organizational skills.
Proficient in Microsoft Office and electronic Quality Management Systems (eQMS) #FTL