Quality Control Supervisor - Stability

Job Description

Job DescriptionSalary: $94,000 - $107,000

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 livesno 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. Were proud to have some of the worlds 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 Control Supervisor - Stability

The Quality Control (QC) team plays a pivotal role in our mission by ensuring that all products meet rigorous quality standards, from development through production. The QC Stability program specifically ensures that products maintain their quality, safety, and efficacy over time, supporting both regulatory compliance and the companys commitment to excellence.

The Quality Control Supervisor Stability will oversee stability studies across all product stages. This role is responsible for managing stability protocols, coordinating testing activities, supervising staff, and ensuring compliance with CGLP and CGMP guidelines. The ideal candidate has extensive experience in stability studies, demonstrates strong leadership skills, and can drive continuous improvement in QC processes.

What You Need to Succeed:

• Plan, organize, and execute protocols, according to high scientific standards, under minimal supervision following CGLP and CGMP guidelines outlined in the IVT Stability SOP.
• Oversee preparation of Stability study protocols and reports.
• Coordinate the receipt, storage, and distribution of stability study samples for testing.
• Manage Stability Studies for seed bank, intermediates, bulk, blend, and finished products.
• Prepare SOPs, Record Sheets, and other documentation for stability studies, data compilation, trending and reporting of Stability Study outcome.
• Monitor and maintain stability chambers to ensure optimal conditions.
• Compile, trend, and report stability study outcomes to QC management and cross-functional teams.
• Initiate change control and raise nonconformance reports for stability-related OOS and OOT results.
• Coordinate shipment of samples to external qualified laboratories for testing as needed.
• Maintain accurate and detailed laboratory notebook and documentation according to regulatory guidelines.
• Effectively prioritize tasks to meet goals and drive projects to completion according to timelines.
• Lead, mentor, and evaluate staff performance, including mid-year and annual performance reviews.
• Provide guidance, training, and support team members to drive quality and compliance.
• Present stability study results and progress updates to QC management and other stakeholders.
• Participate in continuous improvement initiatives and drive positive changes within the QC Stability team.
• Any other responsibilities assigned by QC Director.

Other functions:

• Comply with all training, CGMP, and safety requirements per Inventprise policies.
• Demonstrate effective and efficient use of computer-based technology to manage workflow.
• Uphold employee conduct standards in alignment with Inventprise Human Resources Manual.

Required Qualifications:

• A minimum of Bachelors degree in a scientific discipline such as Chemistry, Biochemistry, Microbiology, Biology, or Biotechnology.
• 10+ years of experience in a laboratory setting, including:
  • Minimum 5 years in stability studies (protocol development, execution, reporting).
  • Prior experience supervising a QC or stability team, or relevant experience.
  • Experience with CGLP and CGMP regulations and regulatory submissions.
• Strong leadership and team management skills with proven ability to drive results.
• Excellent organizational, analytical, and problem-solving skills.
• Proficient in laboratory documentation, data analysis, reporting and statistics.
• Ability to manage multiple priorities, set goals, and meet deadlines in a dynamic environment.
• Strong communication and collaboration skills, with experience presenting results to cross-functional teams and management.
• Demonstrated commitment to quality, compliance, and continuous improvement.

Preferred Qualifications:

• Advanced degree in a scientific discipline.
• Experience with MiniTab statistical software.
• Experience preparing shelf-life analysis reports for regulatory bodies.
• Experience in change control, deviation management, and corrective actions.
• Knowledge of regulatory requirements for pharmaceutical or biotech products.
• Familiarity with stability chambers, sample handling, and shipment coordination.
  

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 Woodinville with occasional travel to Redmond, WA. No remote or hybrid work is available for this position.
  
• Availability to work in our Woodinville and/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:

• $94,000 - $107,000 / 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 Companys Bonus and Stock plans.

Our People-First Philosophy

At Inventprise, youll 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.