Quality Assurance Specialist I-II

The role

This person will support the ISO 13485-compliant Quality Management System. They will manage change control, nonconformance, CAPA, batch record reviews, and validation.

What you will do

• Support production quality processes including change control, NC management, and CAPA management
• Participate in NC or CAPA investigations related to manufacturing, testing and control systems
• Review and approve quality documents, records and reports
• Support customer complaint investigations
• Perform quality reviews for calibration and validation
• Prepare and analyse routine QMS metrics and reporting
• Support quarterly and annual management reviews
• Lead improvement projects from NC, CAPA, internal audits, and site or department goals
• Support external and supplier audits
• Support training management, internal audits, and document control activities

Required qualifications

• Bachelor’s degree (or equivalent) or higher in molecular biology or related field
• 5-7 years of quality experience (NC, CAPA, root cause investigations, internal and external audit) with molecular biology product (or similar) manufacturing, support, and/or product development
• Demonstrated excellence in both written and verbal communication
• Strong interpersonal skills
• Ability to work as an effective member of cross-functional teams
• Able to work independently with responsibilities and stakeholders across multiple global sites
• Ability to think on your feet and address problems with a solutions focused outlook
• Outstanding attention to detail
• Excellent organisational skills
• Ability to multitask, perform consistently under pressure and work without supervision
• Growth mindset, open to feedback and willing to continue to learn and grow
• Committed to product quality with a high level of self motivation

Nice to have

• ISO 13485, ISO 9001, or cGMP industry experience
• Experience performing, supporting, or participating in internal and external audits
• Experience with equipment and processes involved in the manufacturing of genomics reagents or medical devices
• Bachelor's degree in biochemistry, molecular biology, or a closely related discipline preferred

Benefits

• Flexible Time Off
• Holidays
• Employer covers 75% of base medical plan with buy-up options
• Employer paid dental
• Employer paid vision
• Employer paid $25,000 life/AD&D policy
• Paid parental leave
• 401(k) retirement plan with a 4% match

Before you apply

• Submit a Letter of motivation in PDF format
• Applications without a Letter of Motivation will not be considered
• All applicants will be asked if currently eligible to work in the United States of America and if they will require visa sponsorship
• May be subject to pre-employment checks including driving history check, drug screening and a background check

About the company

Watchmaker Genomics is an equal opportunity employer committed to creating a culturally diverse environment.