Senior Quality Assurance Specialist

The Opportunity:

Avantor, a Global Fortune 500 company is looking for a dedicated Senior Quality Assurance Specialist to optimize our Clinical Services organization. This Leesburg, VA role is full-time, on-site.

If you have experience working within a GLP, GCP and/ or GMP environment – let’s talk!

Minimum Education Requirement:

• Bachelor’s degree

Required Experience (2+ yrs):

• Business level verbal and written communication skills.
• Working within a GLP, GCP or GMP environment
• Communicating internally with an Archives team and externally with clients in a business- like professional manner
• Demonstrating a high level of attention to detail
• Working independently to solve problems
• Performing liaison and coordinating activities requiring complex arrangements.
• Utilizing discretion, good judgment, organizational skills, and initiative, while working independently with minimal supervision.
• Maintaining confidential information related to clients' and archive operations.
• Direct involvement conducting deviation and CAPA investigations
• Collaboration skills (IE Microsoft Office)
• Balancing and coordinating workload and prioritizing multiple projects.
• Performing under pressure
• Applying and explaining information in compliance with applicable regulations, policies, and/ or SOPs (standard operating procedures)

Preferred Experience:

• Leading client inspections while performing associated duties (IE, agendas, summary reports, and follow-up to ensure resolution of findings).
• ISO 9001 
• Hosting/co-hosting regulatory inspections and assisting with related responsibilities (e.g., daily summary reports, copying of materials)
• Scheduling/conducting assessments of critical service providers/suppliers for suitability of use; and distributing those findings to an archives management team and vendors for resolution.

How you will thrive and create an impact:

As a primary member of the Quality Assurance team the Senior Quality Assurance Specialist you will:

• Be responsible for taking the lead in evaluating overall compliance of the EPL facilities with applicable SOPs and regulatory requirements. 
• Invoke strong attention to detail while maintaining a high level of quality work product utilizing problem-solving skills
• Participate in Avantor planning activities and/or committee assignments. 

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!

ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT

The work environment characteristics and physical effort described here are representative of those personnel may encounter while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  Typically works in an office, laboratory, or archive environment with adequate lighting and ventilation and a normal range of temperature and noise level.  Required to stand and walk for a portion of the working day. The physical requirements of the job are for associates to talk, hear, bend/stoop, squat, crawl, climb height, reach above shoulder height, crouch, kneel, balance, and push/pull.  Both hands used for repetitive actions such as grasping and manipulating. Specific vision abilities required by this job include close vision, peripheral vision, depth perception, and the ability to adjust focus.

Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classific