Quality Assurance Specialist I-II

Watchmaker Genomics, Inc.; Boulder (CO); On-site; USD 75,000 - 85,000; Full time

Benefits offered by this job

Flexible Time Off

Holidays

Medical plan covered 75% with buy-up

Dental coverage

Vision coverage

Life/AD&D policy

Parental leave

401(k) retirement plan with 4% match

Job summary

Watchmaker Genomics, Inc. in Boulder, CO is seeking a Quality Assurance Specialist I-II to join our QA team.

This full-time, onsite position reports to the QA Manager and collaborates with production, QC testing, and global partners to ensure high-quality genomics products.

Qualifications

• Bachelor’s degree required in biochemistry, molecular biology, or related discipline; 5–7 years quality experience in industry, NC, CAPA, root cause investigations, audits.

Responsibilities

• Support change control, NC, CAPA, data analysis and continuous improvement.
• Review and approve quality documents, records and reports including batch records and CAPA investigation reports.
• Support customer complaint investigations and QA metrics reporting.
• Lead improvement projects initiated from NC, CAPA, internal audits, or site goals.
• Support external and supplier audits and training/document control activities.

Skills

Quality Assurance

CAPA

NC investigations

Audit readiness

Change control

Document review

Data analysis

Cross-functional teamwork

Attention to detail

Problem solving

Education

Bachelor’s degree in biochemistry, molecular biology, or related field

Tools

QMS

Job description

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 analyse 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 organisational 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, 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

Compensation

The base compensation for the Quality Assurance Specialist role starts at $75,000-$85,000 + bonus + equity; actual pay will be adjusted based on skills and experience. Employees are eligible for Flexible Time Off, Holidays, employer covers 75% of base medical plan with buy-up options, employer paid dental, employer paid vision, employer paid $25,000 life/AD&D policy, paid parental leave, and a 401(k) retirement plan with a 4% match.

• WE ARE AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER

Watchmaker Genomics is committed to being an equal opportunity employer and creating a culturally diverse environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics as protected by applicable law.

All applicants will be asked if currently eligible to work in the United States of America; and if now or in the future will require visa sponsorship to continue working in the United States.

This position may be subject to pre-employment checks, including driving history check, drug screening and a background check for any convictions directly related to its duties and responsibilities. All pre-employment checks will comply with all applicable federal, state, and local laws.