Senior Quality Assurance Specialist

Posted 19 Hours Ago
Be an Early Applicant
Leesburg, VA
Mid level
Biotech
The Role
The Senior Quality Assurance Specialist will lead efforts to evaluate compliance with SOPs and regulatory requirements in a clinical services environment. Responsibilities include managing inspections, conducting investigations, collaborating with teams, and ensuring adherence to quality standards.
Summary Generated by Built In

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 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, 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 [email protected] and 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 Equal Employment Opportunity is THE LAW Poster, EEO is the Law Poster Supplement, and Pay Transparency Non-Discrimination Provision.

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.

The Company
HQ: Radnor Township, PA
9,968 Employees
On-site Workplace
Year Founded: 1904

What We Do

Avantor®, a Fortune 500 company, is a leading global provider of mission-critical products and services to customers in the biopharma, healthcare, education & government, and advanced technologies & applied materials industries.

Our portfolio is used in virtually every stage of the most important research, development and production activities in the industries we serve.

Our global footprint enables us to serve more than 225,000 customer locations and gives us extensive access to research laboratories and scientists in more than 180 countries. We set science in motion to create a better world.

More than 13,500 strong, our associates are passionate about our mission to set science in motion to create a better world. We share enthusiasm for innovation, excellence, and achievement. Whether we are collaborating with our customers to advance science or solve multifaceted problems, we help them reach their goals more efficiently and effectively.

Visit our website to learn more about Avantor.


From FORTUNE. © 2021 FORTUNE Media IP Limited All rights reserved. Used under license. FORTUNE is a registered trademark of FORTUNE Media IP Limited and is used under license. FORTUNE and FORTUNE Media IP Limited are not affiliated with and do not endorse products or services of, Avantor.

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