Quality Production Specialist

Watchmaker Genomics

Watchmaker Genomics

Quality Assurance
Boulder, CO, USA
Posted on Thursday, June 27, 2024

Position: Quality Production Specialist
Position Type: Full-Time
Department: Quality / Production
Location: Boulder, onsite
Experience: Bachelor’s or higher degree in biochemistry, molecular biology, or a closely related discipline preferred, + 2-3 years quality and / or production experience in industry

Position Description:

This position works jointly with Production and Quality Assurance (QA) leadership and will be responsible for supporting production tasks within the operation, management, and continuous improvement of Watchmaker’s Quality Management System (QMS).

The successful candidate will work within and support our world-class ISO 13485-compliant QMS in a dynamic, fast-paced working environment and contribute directly to our company culture and success. The position provides an opportunity to work and collaborate closely with Production partners (manufacturing, quality control testing, fill and finish) and QA 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 core QMS processes in support of nonconformance (NC) and corrective and preventive action (CAPA) investigations and through implementation of process changes and improvements. You will work with production and QA teams that value both internal and external customer service, collaboration, scientific rigour, creativity, and innovation, all while ensuring product quality and compliance.

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
  • Take ownership and drive completion of NC and CAPA investigations related to manufacturing, quality control (QC) testing, and / or manufacturing control systems
  • Build and maintain manufacturing expertise through regular participation in weekly department activities and manufacturing events
  • Serve as point of contact and coordinator for global change control system, including change management and reporting
  • 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
  • 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
  • Lead / support training sessions to broader quality and manufacturing teams
  • Support external audits and supplier audits
  • Other activities may include supporting training administration and management, internal audits, direct manufacturing support, and document control activities in our drive for continual improvement

Skills and Requirements:

  • Bachelor’s Degree or higher in biochemistry, molecular biology, or a closely related discipline
  • 2-3 years of Production or Quality Assurance 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
  • Ability 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
  • A growth mindset, are open to feedback and are willing to continue to learn and grow your knowledge, skill set and personal leadership capacity
  • Commitment to product quality with a high level of self motivation
  • Ability 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 in a manufacturing environment, including equipment and processes involved in the manufacturing of genomics reagents or medical devices
  • Experience with investigation and root cause analysis tools and methodology

Compensation:

The base compensation for the Quality Production Specialist role starts at $55,000 - $65,000 + 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.

Application Requirements:

To apply for the position, please submit the following in a PDF format on watchmakergenomics.com:

  • Letter of motivation (upload where it says cover letter)
  • Resume or Curriculum vitae, highlighting relevant qualifications and experience

Applications without a Letter of Motivation will not be considered. Local candidates preferred.

If selected to participate in the interview process, the names and contact information of three professional references who are able to assess your suitability for the position in terms of the specified requirements will be requested.

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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.