Quality Specialist I/II

About the role

Rhode Island Blood Center (RIBC) is seeking a Quality Specialist I or II to join our dynamic team. The ideal candidate will play a crucial role in ensuring the quality and safety of products and services through the application of quality principles and practices.

Responsibilities

• Protects patient and donor safety by promptly addressing critical quality issues.
• Participates in the implementation and maintenance of the quality management system, including SOPs, processes, IT solutions, and quality tools.
• Performs quality assurance activities in support of NYBCe enterprise program areas.
• Ensures appropriate specifications for NYBCe services and products are defined according to their intended use.
• Verifies that operational SOPs comply with applicable regulations, accreditation standards, and NYBCe policy.
• Confirms that document management and record keeping systems comply with regulatory and accreditation requirements.
• Reviews and approves validation studies for critical processes, equipment, and computer systems.
• Qualifies outside suppliers of reagents, materials, and services used in critical processes according to NYBC standards.
• Assists operational staff in identifying and reporting deviations and other quality events.
• Facilitates external regulatory and accreditation inspections, including preparation and follow-up activities.
• Manages quality events such as adverse events, lookbacks, post-donation information, and complaints.
• Monitors and assesses quality performance and compliance of operational systems.
• Tracks deviation reporting process, including classification, analysis, and follow-up.
• Participates in quality audits and process assessments.
• Trains staff in GMP and quality principles and the use of quality tools.

Requirements

• Quality Specialist I: Associate Degree in life sciences, pharmaceutical, biotech or biologics manufacturing, or quality management with at least 2 years of relevant experience.
• Quality Specialist II: Bachelor's Degree in life sciences, pharmaceutical, biotech or biologics manufacturing, or quality management. ASQ, Six Sigma or Lean Certification is a plus with at least 2 years of specialized experience and 4 years of total relevant experience.

Qualifications

• Valid driver’s license with an acceptable driving record preferred.

Benefits

The Quality Specialist I position offers a salary range of $57,530 to $63,000/Yr, while the Quality Specialist II position offers a salary range of $68,000 to $78,000/Yr. Offers are tailored based on experience, skills, and education.

Pay

Salary ranges for Quality Specialist I and II positions.

Schedule

This is an in-office position.

Skills

Knowledge of quality principles and practices, ability to apply knowledge to design, implement, control, monitor, assess, and continuously improve work processes, proficiency in using quality tools, and strong communication and problem-solving skills are essential.

Benefits

Health insurance, retirement plan, paid time off, and other benefits are offered to eligible employees.