Quality Assurance Specialist -II

Position: Quality Assurance Specialist I-II
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?

• 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

Please note:
The above responsibilities are not exhaustive and other similar duties may be required from time to time.

Skills and 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.

The following skills and experience are requirements 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 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

Additional preferred knowledge and experience

• ISO 13485,…