Quality Assurance Specialist I-II

Watchmaker Genomics•Boulder, CO, CO

4d•$75,000 - $85,000•Hybrid

About The Position

Watchmaker Genomics is hiring a full-time Quality Assurance Specialist I-II for its Quality team in Boulder, Colorado. The position reports to the Manager of Quality Assurance and is onsite, with flexibility to work from home one day per week. The Specialist works with production partners in manufacturing, quality control testing, and fill and finish, and collaborates with colleagues in Boulder and Cape Town to support consistent delivery of high-quality products to global genomics and synthetic biology markets. The role supports the company’s ISO 13485-compliant Quality Management System and production quality processes, including change control, nonconformance and CAPA management, batch record reviews, facilities management, qualification, and validation. The position contributes to product quality and compliance while supporting an agile, collaborative, and quality-conscious organization. The role requires a bachelor's degree or equivalent or higher in molecular biology or a related field, and 5–7 years of quality experience involving molecular biology products or similar manufacturing, support, or product development. Watchmaker Genomics offers a base compensation range of $75,000–$85,000, plus bonus and equity, with actual pay adjusted based on skills and experience.

Requirements

Bachelor’s degree or equivalent or higher in molecular biology or a related field.
5–7 years of quality experience, including nonconformance, CAPA, root cause investigations, and internal and external audits, with molecular biology products or similar manufacturing, support, or product development.
Excellent written and verbal communication skills.
Strong interpersonal skills and ability to work effectively on cross-functional teams.
Ability to work independently with responsibilities and stakeholders across multiple global sites.
Ability to address problems as they arise with a solutions-focused outlook.
Outstanding attention to detail and excellent organizational skills.
Ability to multitask, perform consistently under pressure, and work without supervision.
Growth mindset; openness to feedback and willingness to continue learning and developing skills and personal leadership capacity.
Commitment to product quality and high self-motivation.
Ability to thrive in a growing, agile, diverse, and inclusive work environment.

Nice To Haves

Experience in an ISO 13485, ISO 9001, or cGMP industry.
Experience performing, supporting, or participating in internal and external audits.
Experience with equipment and processes involved in manufacturing genomics reagents or medical devices.
Local candidates preferred.

Responsibilities

Support a high-quality and high-performance culture across the company.
Support production quality processes, including change control, nonconformance management, CAPA management, data analysis, and continuous improvement.
Participate in nonconformance or CAPA investigations related to manufacturing, testing, and control systems.
Review and approve quality documents, records, and reports, including production batch records, investigation reports, change records, and certificates of analysis.
Support customer complaint investigations.
Perform quality reviews for calibration and validation to ensure compliance.
Prepare and analyze routine QMS metrics and business reports.
Support quarterly and annual management reviews.
Lead improvement projects initiated from nonconformances, CAPAs, internal audits, and site or department goals through completion.
Support external and supplier audits.
Occasionally support training management, perform internal audits, and carry out document control activities.
Perform other similar duties as required.