Title: Quality Assurance Specialist I

Overtime Status: Non-Exempt

Employment Status: Full-Time

Pay Range: $29.00 - $34.00 /Hr

The hiring pay range for this position is $29.00 - $34.00 per hour based on skills, education, and experience relevant to this role.

Inventprise is a mission-driven bio-pharmaceutical company addressing global health inequalities by empowering people to live healthy lives. We do this by developing novel vaccines targeting infectious diseases for which there are no current preventive interventions or by optimizing currently marketed vaccines to provide a broader spectrum of protection, making them cheaper and more stable than before. We aspire to provide breakthrough public health interventions for all populations, globally. Inventprise is led by pioneers in vaccine discovery, seasoned experts in manufacturing and vaccine development, and proven commercialization veterans.

At Inventprise, we believe our people are our most valuable asset. We are strongly committed to a range of workplace programs that support the well-being, growth, and engagement of our employees and our business. What we offer:

Benefits:

Effective the first of the month following the date of hire, employees are eligible to participate in the following Inventprise employee benefit programs:

• Medical, Dental, Vision, FSA, or HSA: Currently Inventprise contributes 80% toward the Medical, Dental, and Vision coverage for the employee, and enrolled spouse and dependents. Medical plans are currently provided through Premera Blue Cross.
• 401(k) program: Inventprise contributes 3% of employee base pay each pay period to their 401(k) account. Employee contributions are at the discretion of the employee.
• Paid Time Off: Employees start PTO accruals at the rate of 5.83 hours each pay period - annualized equivalent of 140 hours/year.
• Paid Holidays: Inventprise offers 7 paid holidays each year: New Year's Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day, Day after Thanksgiving Day, and Christmas Day.
• Stock & Bonus Plans: Employees are eligible to participate in the Company’s Bonus and Stock Award Plans.

Job Summary:

Job Responsibilities (include, but are not limited to):

Essential Functions

• Register’s equipment and instrumentation onto the IVT master asset list, as well as the calibration and preventative maintenance program.
• Maintains and review validation protocols and reports.
• Prepares selected training programs for specific quality systems subjects, such as GMP, data integrity, and good documentation practices.
• Supports Safety Training.
• Verifies product changeovers (PCOs)/line clearances used to ensure proper cleaning, disinfections, and release of work areas and equipment for subsequent use.
• Reviews and approves applicable logbooks and test records to ensure complete, timely, and accurate recording of data.
• Applies good documentation practices in all aspects of executing job responsibilities, which include the routine and random review of IVT GMP documentation.
• Maintains and archives all Material Safety Data Sheets (MSDS) for all chemicals used at Inventprise, as well as for IVT finished products.
• Supports and reviews data integrity program as needed.
• Supports and facilitates IVT material controls in order to assure consistent and appropriate assignment of material quality status, retest date/ expiration date, first-in, first-out (FIFO), segregation of quarantine and rejected materials, and associated documentation and inventory tracking of GMP materials.
• Supports the IVT room checklist program to assure routine facility conditions are acceptable for use, and that housekeeping and/or maintenance needs are elevated immediately.
• Oversees IVT pest control program, materials used, applications, and associated contractors.
• Ensure proper document archiving and record retention programs are put into place and enforced.
• Supports associated investigations and impact assessment when excursions occurs.
• At management’s request, conducts internal compliance audits, which may be scheduled in accordance with procedure, or for cause.

Required Qualifications:

• Bachelor’s degree in a scientific discipline such as chemistry, biochemistry, microbiology, or biology.
• Previous experience in the pharmaceutical industry.

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.