Biopharma Production QA Analyst

The Opportunity:

Works independently under close supervision, work closely with various departments to perform and validate test cases based on quality requirements, and recommend changes to predetermined quality guidelines. Responsible for ensuring that the end product meets the minimum quality standards, is fully functional and user-friendly. Interpret and implement quality assurance standards and provide accurate and comprehensive feedback to colleagues. Develop and execute test plans to ensure that all objectives are met.
Implement and monitor test scripts to assess functionality, reliability, performance, and quality of the service or product. Identify and remedy defects within the production process.

How you will thrive and create an impact:

• Knowledge of current Good Manufacturing Practices (cGMPs) and regulations from the United States Pharmacopeia (USP), European Pharmacopeia (EP), Japanese Pharmacopeia (JP), International Pharmaceutical Excipient Council (IPEC), and the FDA (CFR Part 210 and 211) related to managing stability program

• Assist in the preparation of stability protocols and final reports.

• Plan, organize, and manage stability studies by ICH and FDA guidelines.

• Review and analyze stability data to identify trends and report findings to stakeholders.

• Maintain the stability chamber inventory and monitor the stability chamber performance.

• Receives incoming stability samples, including logging, labeling, and storage of stability samples. Ensure all applicable safety and compatibility storage requirements are adhered to.

• Manages the distribution of stability samples from the stability chamber to the appropriate laboratory.

• Coordinate stability studies, tracking and maintaining schedules and ensuring timely execution of stability protocols.

• Generate and distribute a monthly stability dashboard that includes stability pull dates and status updates to cross-functional teams.

• Oversee the disposal or shipping of completed stability samples.

• Represent the stability program as a Subject Matter Expert  (SME) during internal/external audits.

• Scheduling and manage the transportation of incoming samples.

• Collaborates with cross-functional teams to maintain the integrity of stability data, and ensures timely testing and reporting of stability study data.

• Assist Laboratory Management with stability study Out of Specification Investigations.

Who you are:

Bachelor’s degree in science, chemistry or engineering
5+ years of laboratory experience, including stability testing

What we are looking for:

Knowledge in current Good Manufacturing Practices (cGMPs) and regulations from the United States Pharmacopeia (USP), European Pharmacopeia (EP), Japanese Pharmacopeia (JP), International Pharmaceutical Excipient Council (IPEC), and FDA (CFR Part 210 and 211) related to managing stability programs.

Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

Why Avantor?

Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.
 
The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.
 
We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!

EEO Statement:

We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, nati