Quality Control Analyst I - Stability

Title: Quality Control Analyst I

Overtime Status: Non-Exempt

Employment Status: Full-Time

Pay Range: $30.00 - $34.00 / hourly DOE

The hiring pay range for this position is $30.00 - $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 9 paid holidays each year: New Year's Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day, Day after Thanksgiving Day, Christmas Day, and two floating holidays.

• Stock & Bonus Plans: Employees are eligible to participate in the Company’s Bonus and Stock Award Plans.

Responsibilities:

• Plan, organize, and execute protocols, according to high scientific standards, under minimal supervision following GLP and cGMP guidelines.

• Preparation of Stability study protocols and reports.

• Receipt, storage, and distribution of stability study samples for testing.

• Coordination of Stability Studies for Seed bank, intermediates, bulk, blend, and finished products.

• Preparation of SOPs, Record Sheets, and other documentation for stability studies.

• Data compilation, trending and reporting of Stability Study outcome.

• Monitoring and maintenance of Stability Chambers.

• Responsible for communication of Stability study results to respective departments.

• Periodically present results and summarize progress to team members

• Initiation of Change control and raising nonconformance pertaining to stability studies.

• Coordination and shipping of samples to external qualified laboratories for testing.

• Maintain accurate and detailed laboratory notebook and documentation according to regulatory guidelines.

• Support the laboratory to perform variety of wet chemistry, biological and chromatographic assays, and methods for performing assay qualifications and provide results according to a timeline.

• Effectively prioritize tasks to meet goals and drive projects to completion according to timelines.

• Any other responsibilities assigned by the Team Lead.

Education:

• BS, Life Science with minimum 1 year of experience in conducting Stability Studies.

• Should have sound knowledge of Stability guidelines.

• Should have good communication and writing skills.

• Should have statistical knowledge of analyzing the data

Physical & Mental Demands:

• Work around chemicals and ability to walk and stand for periods of time.

• Repetitive bending and reaching to set up and break-down equipment.

• Wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases.

Working Conditions:

• Onsite presence is required in Washington, US.

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.