Quality Assurance Lead
1 month ago
**Drive Regulatory Compliance and Quality Excellence in biologicals for In-Vitro, Diagnostics and Research**
**Company Overview**:
**Position Overview**:
We are seeking an experienced Quality Assurance Lead to ensure the highest standards of quality, regulatory compliance, and documentation in our products and processes. This role offers a challenging opportunity to lead quality assurance initiatives, drive continuous improvement, and collaborate with cross-functional teams to maintain and enhance our Quality Management System (QMS) and compliance with FDA regulations, ISO standards, and GMP.
**Responsibilities**:
- Lead the implementation, communication, and maintenance of quality assurance standards and procedures to ensure compliance with regulatory requirements and industry best practices.
- Conduct internal audits, quality audits, inspections, and evaluations of processes, products, and controlled documentation.
- Identify, investigate, and resolve quality issues, non-conformances, and customer complaints.
- Collaborate with cross-functional teams to implement corrective and preventive actions (CAPAs), improve quality systems, and maintain the QMS.
- Analyze data and provide insights to drive continuous improvement in quality and operational efficiency.
- Prepare reports and analysis for senior management.
- Lead the assessment, documentation, and review of Standard Operating Procedures (SOPs) and quality documentation.
- Be a liaison between Subject Matter Experts (SMEs) and Quality Assurance professionals facilitating communications, projects and results.
**Requirements**:
- Bachelor’s degree in biology, a scientific/healthcare-related field, engineering, IS, or business administration.
- Minimum of 4 to 6 years of experience in quality assurance, preferably in the healthcare/life sciences industry. Familiarity or experience in Blood Banking or Clinical Laboratories is a plus.
- Strong quality acumen and knowledge of QMS.
- Strong analytical, problem-solving, and organizational skills.
- In-depth knowledge of ISO 9001 standard and GMP. Proficient in reviewing/assessing the CFRs and FDA guidelines is a plus.
- Proficiency in data analysis tools and software.
- Excellent verbal and written communication and interpersonal skills.
**What We Offer**:
- **Engaging Environment**: Experience development opportunities aligned with business priorities, quality products, and processes.
- **Modern Employee Experience**: Benefit from emotional compensation based on best practices and continuous improvement.
- **Fair Treatment**: Operate and make decisions based on merit, qualifications, and performance.
- **Challenging Work**: Engage in a constantly evolving environment maintaining specialized licenses and complying with regulatory standards.
- **Comprehensive Benefits and compensation**: PTO, Selected Federal Holidays, Health insurance, Dental, Vision, GAP, 401k/Profit Sharing program after a probationary period.
**Expectations**:
- **Communication**: Maintain open, effective and professional communication with your supervisor and cross-functional teams.
- **Entrepreneurial Spirit**: Desire for growth and innovation, following instructions, but also proposing solutions. Flexibility and adapting competencies will be critical.
- **Timeliness**: Be punctual and work around critical projects, timeframes,
- **Teamwork**: Collaborate effectively with team members across the organization.
- **Flexibility**: Willingness to work at both Miami and Fort Lauderdale locations if necessary.
- **Continuous Learning**: Be open to learning and growing within the organization.
**About CSG**:CSG has been an FDA-licensed facility since 1971, holding multiple city, state, and federal licenses, and has been ISO 9001 certified since 2003. We provide blood components and other biological raw materials to our global customers for the manufacturing of in-vitro diagnostic products. Our repeat-donor base enables us to provide extensively tested and unique products to the pharmaceutical industry.
Join us at CSG to lead regulatory compliance, drive quality excellence, make a meaningful impact in healthcare and research, and grow with a company that values innovation, development, and teamwork
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