Quality Assurance Specialist
hace 3 semanas
Company Overview:
Vision Achievement is a leading consulting firm in the life sciences industry, providing expert services to clients worldwide. Our team of professionals has extensive experience in quality assurance and regulatory affairs, helping clients navigate complex regulatory landscapes and achieve their business goals.
Estimated Salary: $120,000 - $180,000 per year
This role is primarily based in the USA and requires US citizenship or permanent residency.
Job Description:
We are seeking a highly experienced Quality Assurance Specialist with expertise in regulatory affairs to join our team. The successful candidate will be responsible for planning and delivering quality consulting engagements related to regulatory affairs infrastructure, appropriate to the level of risk in a target product. This includes auditing design and manufacturing processes, interpreting and applying codes, regulations, and standards, as well as implementing quality systems and ensuring compliance with relevant regulations such as 21 CFR Part 211.
Key Responsibilities:
• Conduct audits and assessments of quality systems, processes, and procedures
• Develop and implement corrective actions to address deviations and non-compliances
• Collaborate with cross-functional teams to ensure seamless delivery of projects
• Provide training and guidance to staff on quality systems and regulatory requirements
• Stay up-to-date with emerging trends and regulatory changes in the life sciences industry
Required Skills and Qualifications:
• Bachelor's degree in a relevant field (e.g., engineering, science, or life sciences)
• Significant experience in RA/QA matters related to medical devices, pharmaceuticals, cosmetics, and other life sciences industries
• Expertise in auditing design and manufacturing processes, interpretation and application of codes, regulations, and standards, GMP, and quality systems planning and implementation
• Excellent communication and interpersonal skills, with ability to work effectively in a team environment
• Strong analytical and problem-solving skills, with ability to think critically and make sound decisions
• Ability to travel extensively domestically (25% - 50%), with occasional international travel required
Benefits:
• Competitive salary and benefits package
• Opportunities for professional growth and development
• Collaborative and dynamic work environment
• Flexible work arrangements, including remote work options
How to Apply:
If you are a motivated and experienced quality assurance specialist looking for a new challenge, please submit your resume and cover letter for consideration. We thank all applicants for their interest; however, only those selected for an interview will be contacted.
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