Senior Quality Assurance Specialist

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 - Senior Quality Assurance Specialist:

The Senior Quality Assurance Specialist 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 Inventprise (IVT) project teams and represent Quality Assurance in everyday activities.
• Serve as the main point of contact and Subject Matter Expert for review and approval of cGMP Controlled Documents, such as Batch Production Records, raw QC data, and overall disposition of the lots.
• Oversee activities during cGMP production operations and perform Production Changeover.
• Review and manage Quality Events to ensure the best compliant pathway such as non-conformances, change control or other regulatory accepted risk-based approaches and offer solutions for continued improvement.
• Ensure compliance with approved procedures, cGMP expectations, and make sure timelines are met.
• Provide problem solving expertise, review and manage required changes to meet cGMP and internal standards and production timeline.
• Support internal audits – including development of audit plan and assist in the corrective actions.
• Develop and review Standard Operations Procedures as needed, to maintain quality systems in line with current regulations and industry standards.
• Provide regular metrics reports and other trend data as needed for Quality management review meetings.
• Participate in future continuous improvement upgrade of the validated electronic Quality Management system.

Required Qualifications:

• Bachelor’s degree in scientific discipline such as chemistry, biochemistry, microbiology, or biology.
• Minimum of 8 years of direct QA work experience, including at least 5 years in regulated cGMP manufacturing facilities in the pharmaceutical or biotechnology industry.
• Strong working knowledge of GxP regulations, with an emphasis on GMP compliance.
• Proven ability to interpret and apply regulatory requirements to manufacturing and quality processes.
• Experience reviewing and approving GMP documentation, such as batch records, quality events, and SOPs.
• Demonstrated ability to work cross-functionally and manage multiple priorities in a fast-paced, dynamic environment.
• Strong written and verbal communication skills, with the ability to provide clear guidance and feedback.
• Familiarity with electronic Quality Management Systems (eQMS).
• Experience supporting regulatory inspections (FDA, EMA, or other agencies).

Physical Demands:

• Frequently use of office equipment that requires manual dexterity to operate (i.e. computers, phones, etc.).
• Occasional carrying, handling, and reaching for objects up to 30 pounds.
• Frequently sit or stand for long periods of time.

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:

• $105,000 - $113,500 / yearly DOE
  
• It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case.
• The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location.

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.

Salary : $105,000 - $113,500