Senior QA Analyst

The Opportunity:

Avantor, a Global Fortune 500 company is looking for a dedicated Senior QA Analyst to optimize our Quality organization.

This USA – Remote based role is full-time. If you have quality assurance experience – let’s talk!

Minimum Education: Bachelor’s Degree in a Science related field.

Required Experience (7+ years):

• Manages Compendial Compliance activities, as SME, for USP, EP, BP, JP, ChP, FCC, etc.
• Manages compendial related document updates, as needed.
• Modifying working methods using defined procedures.
• Implementing operational plans for job area and implementing new products, processes, standards, or operational plans that will have a significant impact on the achievement of sub-function results driven by compendial update.
• Works within and enforces GxP principles.
• Data entry and databases, related software, and document control systems.
• Experience of working within a Quality Management System (QMS)
• Experience of working with Collaboration tools (i.e.: Microsoft Office).
• Experience and familiar of navigating SAP to review master data.
• Familiar with Empower CDS, LabVantage LIMS and Document control platforms (i.e., EtQ, etc.).

Preferred Experience:

• Perspective of reviewing laboratory CAPAs to ensure an effective CAPA plan and acceptable interim control and manage updates to analytical methods / specifications.
• Perspective of working in a cGMP lab; science background preferred.
• Experience following guidelines to assess risk and prioritize work based on scope and priority.
• Comfortable engaging Quality Management regarding elevated risk factors.
• Comfortable working with stability SMEs to obtain data supporting customer product information requests.

How you will thrive and create an impact:

This role will partner with various global and site organizations to achieve business goals and to provide support ad hoc to ensure deliverables are met for global quality initiatives. It requires someone that is detailed oriented, with strong organizational skills, ability to multi-task, prioritize workload and work independently to meet commitments with minimal supervision.

You would also be responsible for customer support, regulatory and technical service product information requests, review for compendial updates, and routinely ensure analytical methods are kept in state of compliance. 

Driving process improvement for Global Analytical Method Transfers and Global Compendial Management.

• Owning global process for compendial management and update activities as SME.
• Developing and supporting Analytical Method Data Equivalency process for products.
• Initiating, revising, reviewing, and approving Standard Operating Procedures (SOP) for Global Laboratory Services.

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!

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