Senior Quality Assurance Specialist

Canyon Labs exists to raise the standard of services in the Medical Device and Pharmaceutical markets by providing streamlined and expert solutions in technical consulting, sterilization, analytical testing and packaging.

We are committed to ensuring that quality services are delivered by meeting or exceeding customer expectations, continuously improving the effectiveness of the quality system, and ensuring compliance with regulations, standards and directives.

Position Title: Senior Quality Assurance Specialist

Location: Onsite at Canyon Labs in Rush, NY

Schedule: Monday – Friday 8:00AM – 5:00PM

Annual Salary Range: $60,000 - $75,000

Senior Quality Assurance Specialist Job Summary:

The Senior Specialist, Quality, is primarily responsible for reviewing GLP (21CFR58) and GMP/QMSR (21CFR210/211, 21CFR820/ISO 13485) study data and reports, conducting QA GLP study activities, including phase audits, and participating in the management of quality system activities in alignment with the CFR and ISO 17025 as applicable. Responsible to track performance to ensure timely and successful completion of equipment and computerized system validation plan and periodic review. As part of the Quality team, ensure the Quality System is robust and in compliance with regulatory and notified body expectations. Provide support for routine customer audits, regulatory agency inspections and notified body assessments. Conduct internal and supplier audits.

Job Responsibilities:

• Develop, publish, and track to completion the annual Validation Master Plan in conjunction with Lab Operations
• Review and approve Equipment and Computerized System Validation documents
• Perform routine management of external standards
• Review GLP and GMP study data and reports for the testing departments
• Conduct GLP study phase audits, internal and supplier audits
• Assist site head of Quality to host customer, regulatory and notified body inspections
• Assist with Quality System Training (QMSR, ISO, GMP and GLP)
• Assist in the management of quality system activities
• Write / approve work instructions
• Management of quality system events such as deviations, investigations, CAPAs, nonconforming material reports, audit finding responses, etc.
• Document change control (SOPs, Forms)
• Equipment/Process Change Control
• Participate in quality improvement projects
• Additional Quality Management System process support as assigned

Requirements:

Bachelor’s or Associate’s degree in a scientific or technical discipline (e.g., Chemistry, Biology, Microbiology, Engineering, or related field), or equivalent experience. · Minimum of 4 years of Quality Assurance or other relevant experience in medical device or pharmaceutical laboratory testing or manufacturing.

Senior Quality Validation Specialist Preferred Knowledge, Skills and Abilities:

· Strong understanding of GLP (21 CFR Part 58), GMP/QMSR (21 CFR Parts 210/211/820), and ISO/IEC 17025 principles.

· Experience writing, conducting and reviewing equipment and computerized systems validation

Experience coordinating and hosting customer, supplier, and/or regulatory audits.

· Demonstrated experience supporting or writing investigations, deviations, nonconformances, and corrective actions.

· Strong working knowledge of Quality Management System (QMS) processes, including change control, document control, and training management.

· Excellent written and verbal communication skills, including the ability to draft clear, accurate, and compliant documentation.

· Strong organizational skills and high attention to detail, with the ability to manage multiple priorities and deadlines.

· Ability to work independently and collaboratively with laboratory operations, and quality teams.

· Proficiency with Microsoft Office applications and comfort working with electronic QMS or LIMS platforms.

Canyon Labs offers several benefits as part of your total compensation, including but not limited to:

• Paid Time Off, Sick Time, and Paid Holidays

• Medical, Dental and Vision Insurance

• Long term disability insurance, life insurance

• 401(k) with company match up to 4%

At Canyon Labs, we are committed to creating a diverse and inclusive workplace. We provide equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other protected characteristic under applicable laws.