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Quality Assurance Manager

Arzeda

Arzeda

Quality Assurance
Seattle, WA, USA
Posted on Monday, September 25, 2023

Located in Seattle, Washington, Arzeda is solving some of today’s hardest and most meaningful problems – from food and nutrition to sustainable materials and homecare – by designing proteins that have the limitless potential to change everyone’s daily life. Our Intelligent Protein Design Technology™ merges computational protein design, machine learning, and synthetic biology tools to produce proteins, enzymes, and bio-based processes more efficiently than even Mother Nature. A deep tech, mission-driven company, we are passionate about our mission to design novel proteins and products that enhance our lives and protect our planet. At Arzeda, we value a strong desire to learn, innovate and be continuously challenged.

We are seeking a Quality Assurance Manager to join our growing team in Seattle, WA. In this role, you will be responsible for defining and promoting a food quality mindset across the entire company and managing all QA functions, working with cross-departmental stakeholders and contract manufacturers to deliver high quality food grade products on schedule. You will leverage your industry expertise to establish and maintain a quality system to ensure the company’s facilities, equipment, personnel, methods, processes and procedures conform to both internal guidelines and regulatory standards including Food Safety, cGMP, Kosher, Halal, etc. This is an exciting opportunity to help build out our quality system as we prepare for our first commercial products!

Responsibilities:

  • Develop, implement, and maintain GMP Quality System requirements on assigned areas of manufacturing, supplier management, process validation, and new products introduction
  • Monitor all compliance programs with weights, processing temperatures, GMP’s and microbial control
  • Develop and communicate plant programs to comply with government standards and HACCP guidelines
  • Monitor and train respective employees and establish safe work procedures
  • Communicate with regulatory agencies, Contract Manufacturers and Customers to resolve quality issues as they arise
  • Develop raw material standards by studying manufacturing and engineering requirements, conferring and negotiating with suppliers, and devising testing methods and procedures
  • Develop and implement programs to ensure raw materials, in-process and final products follow internal and customers established specifications and standards
  • Ensure compliance with FSMA requirements, SQF Code and other applicable Food Safety Management Standards
  • Document processes and procedures which standardize and support company and regulatory information requirements
  • Develop and deploy all key quality systems such as a quality dashboard, customer quality management, change management, supplier quality management, quality control, statistical monitoring, and customer audits
  • Participate in cross-functional project teams ensuring compliance issues are addressed for new product activities
  • Review data for compliance with specifications
  • Perform and review analytical method validations
  • Review, assess, and evaluate validation protocols (IQ, OQ, PQ)
  • Manage supplier approval activities and participate in supplier audits
  • Participate in and coordinate regulatory audits (i.e., FDA & DEA), 3rd party audits, internal and customer audits
  • Provide quality reports and review trending
  • Approve and sign-off on Certificate of Analysis and product specifications

Qualifications:

  • Bachelors degree in Microbiology or related field
  • 5+ years of direct Quality Assurance experience in Food or Biotechnology industries
  • 5+ years of experience in food enzyme manufacturing
  • Proven ability to interface and manage CMO in terms of maintaining food grade quality systems and processes
  • Ability to demonstrate leadership skills and business acumen with a comprehensive understanding of the organization and functional areas
  • Proven success in implementing ISO, FSSC, GMP and other quality assurance practices at multiple sites
  • Experience with FDA and other regulatory audits
  • Demonstrated experience in Quality Management and Regulatory Affairs
  • Formally trained in HACCP implementation
  • Preventative Control Qualified Individual (PCQI) training
  • Understanding of GMP, FSMA, SQF Code Food Allergens and Microbiology
  • Broad knowledge and experience with food grade regulations, sanitation chemical/material use and procedures, food safety procedures, and daily plant inspections, 3rd party audits, food labeling, and product distribution and handling
  • Ability to travel 20-30%

Nice-to-haves (but not required):

  • SQF Certified
  • HACCP and PCQI Certified
  • Prior experience with Six Sigma
  • Prior experience leading FDA and other regulatory audits
  • Knowledge of Kosher and Halal requirements
  • Experience acquiring 21 CFR 117 Certification

**Manager, AD, or Director: Title and compensation will be based on level of experience with requested qualifications.

Arzeda compensation and benefits include:

  • Comprehensive compensation package, to include equity
  • Base Salary: $125,000 - 160,000 (may vary based on level of experience, education and geography)
  • Paid time off; company-observed holidays to include a company paid holiday closure between Dec 25 and Jan 1; and paid medical/family leave
  • Excellent medical, dental, and vision insurance to include options for Health Savings Accounts
  • 401(k) retirement savings plan
  • Commuter benefits

Arzeda is an equal opportunity employer promoting diversity and inclusion in the workspace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, taking or requesting statutorily protected leave, or any other basis protected by law.

Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.