Quality Assurance Specialist

The Quality Assurance Specialist oversees compliance activities and ensures they meet all applicable SOPs and regulatory standards. This position will play a key role in managing elements of the quality systems related to deviations, change control, CAPA, and customer feedback. The successful candidate will possess the ability to collaborate with development and operations personnel across CRSP.

Summary of Key Responsibilities:

• Coordinate record keeping and documentation supporting compliance activities, State licenses and accreditation, including regulatory audit schedule, Personnel training and competency, Equipment and Facilities maintenance records
• Support and/or facilitate QMS review meetings.
• Support and/or facilitate internal audit activities
• Monitor the initiation, tracking, and completion of Quality Management System elements including:
• Deviations
• Change Control
• Investigations
• CAPA
• Complaints

Qualifications:

• Bachelor’s degree in a life science
• 3-5 years laboratory experience.
• Genomics and/or Clinical laboratory experience a plus
• 1-3 years experience with Quality Management Systems.
• Demonstrated knowledge of CLIA/CAP/NYS requirements a plus.
• Excellent written and verbal communication skills
• Highly organized, with strong attention to detail and accuracy