Quality Assurance Specialist I-II

Watchmaker Genomics•Boulder, CO

3d•Onsite

About The Position

Watchmaker Genomics is hiring a full-time Quality Assurance Specialist I-II for its Quality department in Boulder, Colorado. The position is onsite/in-office, with flexibility to work from home one day per week, and reports to the Manager of Quality Assurance. The specialist will work with production partners in manufacturing, quality control testing, and fill and finish, and collaborate with colleagues in Boulder and Cape Town to help deliver high-quality products to customers in global genomics and synthetic biology markets. The role supports the company’s ISO 13485-compliant Quality Management System (QMS) and its quality and compliance goals. Core work includes change control, nonconformance (NC) and corrective and preventive action (CAPA) management, batch record review, facilities management, and qualification and validation. The specialist will contribute to a collaborative, fast-paced environment focused on customer service, scientific rigor, creativity, and continuous improvement. The base compensation starts at $75,000–$85,000, plus bonus and equity, with actual pay adjusted based on skills and experience. Applications are accepted on a rolling basis until the position is filled. Candidates must submit a letter of motivation and a resume or CV in PDF format; applications without a letter of motivation will not be considered. Local candidates are preferred.

Requirements

Bachelor’s degree or equivalent or higher in molecular biology or a related field; the position summary also identifies biochemistry or a closely related discipline as relevant.
Five to seven years of quality experience involving NCs, CAPA, root cause investigations, and internal and external audits in molecular biology product (or similar) manufacturing, support, and/or product development.
Demonstrated excellence in written and verbal communication.
Strong interpersonal skills and ability to work effectively as a member of 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 a high level of self-motivation.
Ability to thrive in a growing, agile, diverse, and inclusive work environment.

Nice To Haves

Experience with ISO 13485, ISO 9001, or cGMP.
Experience performing, supporting, or participating in internal and external audits.
Experience with equipment and processes involved in manufacturing genomics reagents or medical devices.
Local to the Boulder area; local candidates are 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 NC or CAPA investigations related to manufacturing, testing, and control systems.
Review and approve quality documents, records, and reports, including production batch records, NC and CAPA 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 reporting.
Support quarterly and annual management reviews.
Lead improvement projects initiated from NCs, 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.