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MAKE — Boulder, Colorado
Position: Quality Assurance Specialist I-II Position Type: Full-Time Department: Quality Location: Boulder, onsite Experience: Bachelor's degree required in biochemistry, molecular biology, or a closely related discipline preferred + 5-7 years quality experience in industry Position Summary 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. How will you contribute?
Responsibilities
are not exhaustive and other similar duties may be required from time to time.
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
Requirements
The candidate should have a Bachelor’s degree (or equivalent) or higher in molecular biology or related field and 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.
for the position: 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