Job Description

Quality Control Manager

Location: Sunrise, FL / Oakland Park, FL

Employment Type: Full-Time, Onsite

Company: American Cell Technology, the nation's largest personal mesenchymal stem cell bank

Job Summary

American Cell Technology is seeking an experienced Quality Control Manager to oversee the quality assurance and control processes for our mesenchymal stem cell banking operations. The successful candidate will ensure compliance with current Good Manufacturing Practices (cGMP), current Good Tissue Practices (cGTP), FDA regulations, and ISO standards. This role requires strong leadership, process validation expertise, and team management skills to maintain the highest quality standards in a fast-paced, innovative environment.

Key Responsibilities

• Process Validation: Design, implement, and oversee process validation protocols to ensure consistent and compliant production of mesenchymal stem cell products.
• Quality Management: Develop, maintain, and improve quality control systems to ensure product safety, purity, and efficacy in accordance with cGMP/cGTP standards.
• Regulatory Compliance: Ensure adherence to FDA regulations (e.g., 21 CFR Parts 210, 211, 1271) and ISO standards (e.g., ISO 13485, ISO 9001) through regular audits, documentation, and corrective actions.
• Team Leadership: Manage and mentor a team of quality control professionals, fostering a culture of accountability, collaboration, and continuous improvement.
• Testing and Inspection: Oversee laboratory testing, environmental monitoring, and product release processes to ensure compliance with internal and regulatory standards.
• Documentation: Maintain accurate and comprehensive quality records, including SOPs, batch records, and deviation reports, to support regulatory inspections.
• Continuous Improvement: Identify opportunities for process optimization and implement corrective and preventive actions (CAPAs) to enhance quality outcomes.
• Time Management: Prioritize tasks and manage timelines effectively to meet production and regulatory deadlines without compromising quality.
• Cross-Functional Collaboration: Work closely with manufacturing, regulatory affairs, and R&D teams to ensure seamless operations and compliance.

Qualifications

• Education: Bachelor’s degree in a life sciences field (e.g., Biology, Biochemistry, Biotechnology); Master’s degree or higher preferred.
• Experience: Minimum of 5-7 years of experience in quality control or quality assurance in a cGMP/cGTP environment, preferably in cell therapy, biologics, or stem cell banking.
• Regulatory Knowledge: In-depth understanding of FDA regulations (21 CFR Parts 210, 211, 1271) and ISO standards (ISO 13485, ISO 9001).
• Process Validation: Proven experience designing and executing process validation protocols in a regulated environment.
• Leadership: Demonstrated ability to lead and manage teams, with strong interpersonal and communication skills.
• Technical Skills: Familiarity with laboratory testing methods, environmental monitoring, and quality management systems (e.g., QMS software).
• Certifications: Quality-related certifications (e.g., ASQ Certified Quality Manager, Six Sigma) are a plus.
• Skills: Exceptional time management, problem-solving, and decision-making skills; ability to thrive in a high-pressure, regulated environment.

Compensation

• Base Salary: $80,000 - $110,000 per year, commensurate with experience and qualifications.
• Benefits:
• Comprehensive health, dental, and vision insurance.
• 401(k) with company match.
• Paid time off (PTO) and holidays.
• Professional development and certification reimbursement.
• Relocation assistance (if applicable).
• Bonus: Performance-based annual bonus potential of up to 15% of base salary, tied to quality metrics and team performance.

Work Environment

• Full-time, onsite position at our Fort Lauderdale, FL facility.
• Collaborative and innovative workplace with opportunities for career growth.

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