QA Analyst, Global Laboratory Services

The Global Laboratory Services group is looking for a QA Analyst to support compendial updates, change management, method validation protocols and routinely ensure analytical methods are kept in state of compliance. The incumbent will partner closely 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.

What we're looking for

• Education: Bachelor's degree, in a Science related field or equivalent/applicable experience.

• Experience: 2+ years of applicable experience.

• Experience in a cGMP lab; science background preferred.

• Understanding of GxP principles.

• Experience with data entry and databases, related software, and document control systems.

• Knowledge of QMS.

• Good computer skills with knowledge of Microsoft Office functionality.

• Understanding of SAP, LabVantage LIMS and Document control platforms (i.e., EtQ, etc.).

• Familiar with USP, EP, BP, JP, ChP, FCC, ACS, etc.

• Must be detailed oriented, with strong organizational skills, ability to multi-task, prioritize workload and work independently to meet commitments with minimal supervision.

• Works independently with limited oversight from manager.

How you will thrive and create an impact

• Supports Compendial Compliance activities, as directed, for USP, EP, BP, JP, ChP, FCC, etc.

• Supports global process for compendial management and update activities.

• Manages compendial related document updates, as needed.

• Responsible for analyzing analytical method parameters using defined procedures.

• Executes operational plans for job area and implements new products, processes, standards, or operational plans that will have a significant impact on the achievement of sub-function results driven by compendial update.

• Reviews laboratory CAPAs to ensure an effective CAPA plan and acceptable interim control and manage updates to analytical methods / specifications.

• Drive process improvement for Global Analytical Method Transfers and Global Compendial Management.

• Develops and supports Analytical Method Data Equivalency process for products.

• Initiate, revise, review and approve Standard Operating Procedures for Global Laboratory Services.

• Follows guidelines to assess risk and prioritize work based on scope and priority.

• Engages Quality Management regarding elevated risk factors.

• Performs other duties as assigned.

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!

Pay Transparency:

The expected pre-tax pay for this position is

Actual pay may differ depending on relevant factors such as prior experience and geographic location.

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, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at recruiting@avantorsciences.comand let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

For more information about equal employment opportunity protections, please view the Know Your Rights poster.

3rd Party Non-Solicitation Policy:

By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.

Avantor offers a comprehensive benefits package including medical, dental, and vision coverage, wellness programs, health savings and flexible spending accounts, a 401(k) plan with company match, and an employee stock purchase program. Employees also receive 11 paid holidays, accrue 18 PTO days annually, are eligible for volunteer time off and 6 weeks of 100% paid parental leave (except in states that offer paid family leave). These benefits may not apply to employees covered by a collective bargaining agreement or those subject to other eligibility rules.