- 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 analyses 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.
- 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
- Bachelor's degree in biology, a scientific/healthcare-related field, engineering, IS, or business administration.
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Quality Assurance Lead - Doral, United States - USDM Life Sciences
Description
About USDMUSDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth.
Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.As part of the USDM team, you have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more.
From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM's clients.
Are you ready to make an impact and drive real digital transformation in life sciences?Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.
Nature and Scope of JobUSDM is looking for a Quality Assurance Lead for our client. This is a direct hire role.
Primary Responsibilities
Note:
This is a direct Hire Position with our Client.
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