Quality Assurance Specialist I-II

Watchmaker Genomics•Boulder, CO, CO

3d•$75,000 - $85,000•Hybrid

About The Position

Watchmaker is inviting applications for the full-time position of Quality Assurance (QA) Specialist I-II to join our QA Team. This position will be based in Boulder, CO and reports to the Manager of Quality Assurance. The successful candidate will thrive in a dynamic, fast-paced working environment and contribute directly to our company culture and success. The position provides an opportunity to work with our Production partners (manufacturing, quality control testing, fill and finish) and collaborate closely with colleagues in Boulder and Cape Town to ensure that we are successful in consistently delivering high-quality products to our customers in global genomics and synthetic biology markets. Furthermore, you will contribute to a QA team that values both internal and external customer service, collaboration, scientific rigor, creativity and innovation, while ensuring product quality and compliance. This is an onsite/in-office position with flexibility to work from home one day a week. You will work within and support our world-class ISO 13485-compliant Quality Management System (QMS) to continue to build an industry-leading, agile genomics company with a quality-conscious customer base. Your role will involve supporting the quality system aspects of change control, nonconformance (NC) and corrective action and preventive action (CAPA) management, batch record reviews, facilities management, qualification and validation.

Requirements

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 and an 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 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, open to feedback and willing to continue to learn and grow your knowledge, skill set and personal leadership capacity
Committed to product quality with a high level of self motivation
Able to have fun and thrive in a growing, agile, diverse and inclusive work environment

Nice To Haves

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

Responsibilities

Support a high-quality and high-performance culture across the company
Support production quality processes, including but not limited to change control, NC 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, certificates of analysis
Support customer complaint investigations
Perform quality reviews for calibration and validation to ensure compliance
Prepare and analyze routine QMS metrics and reporting for the business
Support quarterly and annual management reviews
Lead improvement projects to completion that may be initiated from NC, CAPA, internal audits, and site or department goals
Support external and supplier audits
Occasional activities will include supporting training management, performing internal audits, and document control activities in our drive for continual improvement