Quality Assurance Specialist II

About Inventprise

At Inventprise, developing innovative and widely available vaccines is in our DNA. By producing targeted vaccines for populations worldwide, we're addressing global health inequalities and empowering people to live healthy lives—no matter where they live. Headquartered in Redmond, WA, our goal is to deliver affordable, effective vaccines at large-scale to Low and Middle Income Countries, as well as populations in the U.S. and around the world. Inventprise is committed to creating a diverse and inclusive workplace, where our people are inspired to do their best work. We’re proud to have some of the world’s most qualified industry scientists, researchers, and manufacturing professionals on our team, and strive to create a vibrant, dynamic presence in the Washington State Life Sciences environment.

What the Role Offers - Quality Assurance Specialist II

The Quality Assurance Specialist II ensures compliance with cGMP regulations by overseeing production activities, managing deviations, and reviewing key quality documentation. They support audits, inspections, and regulatory compliance while contributing to process improvements and maintaining quality systems. The role involves cross-functional collaboration, metrics reporting, and subject matter expertise to uphold manufacturing standards.

What You Need to Succeed

• Participate in internal and external IVT project teams and represent Manufacturing Quality Assurance in Quality Work Groups.
• Serve as a point of contact and provide subject matter expertise for quality related activities.
• Support generation of metrics reports and other trend data as needed for management review meetings.
• Oversee activities during cGMP production operations, perform Production Changeover area and equipment releases.
  
• Manage and review deviations/investigations associated with product non-conformances and product complaint investigations.
• Review and approve cGMP Controlled Documents, such as Master Batch Production Records, analytical test methods, and specification and other operations related documentation.
• Manage and review required changes to meet GMP and internal standards and production timeline.
• Perform batch review and activities ensuring compliance with approved procedures, international GMP expectations, and dispositions timelines are met.
• Support internal and external audits – including development of audit plan, and report corrective actions.
• Participate in regulatory and client inspections and audits.
• Write and review Standard Operations Procedures as needed, assist in the development of Standard Operation Procedures to maintain quality systems in line with current regulations and industry standards.
• Support electronic system continuous improvement and development activities (for example Change Management, Deviations/CAPA, Paradigm Document Management System.)
  

Required Qualifications:

• Bachelor’s degree in a scientific discipline such as chemistry, biochemistry, microbiology, or biology.
• Minimum 2 years of direct QA work experience in the regulated (bio)pharmaceutical/biotech industry.
• Detailed familiarity with GXP regulations. GMP preferred.
  

Physical Demands:

• Must be present on site for all related responsibilities and be able to routinely perform activities as defined above.
• Must be able to stand for extended periods of time.
• Must be able to dress in sterile gowning in the form of scrubs and clean room coveralls.
  
• Ability to handle and work with potentially hazardous chemicals per standard operating procedure.
• Must be able to lift up to 30 pounds.
  

Mental Demands:

• Excellent oral and written communication skills.
• Highly organized with an attention to detail.
• Must maintain a high level of alertness and acuity for analytical review and processing of documentation, daily.
• Able to work independently with changing priorities.
  

Working Conditions:

• Onsite position in Redmond or Woodinville, WA. No remote or hybrid work is available for this position.
  
• Availability to work in our Woodinville or Redmond facilities. 
• Extended periods of time on the computer.
• Extended periods of time on your feet.
• Working in warm environment wearing sterile gowning.
• Working with chemicals per standard operating procedure.
  

Estimated Base Salary: $70,000 - $90,000 / yearly DOE 

Benefits:

• Medical, Dental, Vision, FSA, or HSA: Inventprise contributes 80% toward the Medical, Dental, and Vision coverage for the employee, and their enrolled spouse, and dependents. Medical plans are currently provided through Premera Blue Cross.
• 401(k) program: Inventprise offers both pre-tax 401(k) and post-tax Roth retirement savings plans, letting you decide how you want to save for the future. We also make an employer contribution of 3% of your total earnings each pay period, regardless of whether you contribute.
• Paid Time Off: Generous PTO, in addition to paid holidays.
• Stock & Bonus Plans: Employees are eligible to participate in the Company’s Bonus and Stock plans.

Our People-First Philosophy

At Inventprise, you’ll be part of a world-class team working on innovative vaccines and technologies that have global impact. Our people are an integral part of our strategy, allowing us to grow as a company and improve our performance year-over-year.
Our company was built on the belief that by working together, we have the ability to make the world a better place and improve lives. We have a growth mindset and are constantly looking for ways to enhance our contributions to improve global health. We believe that when we support each other and set high standards, we are able to do our best work.

Equal Opportunity Employer

Inventprise is an equal-opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender, identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.