Quality Assurance Specialist

Avantor is looking for a Quality Assurance Specialist to ensure quality standards are met in a biopharma production environment.

This role will be a full-time position based out of our Devens, MA office.

How you will thrive and create an impact: 

• Supports generation of job packets for Production.
• Supports batch record review process.
• Assist in Label generation.
• Supports certification requests.
• Complies with company policies, procedures, work instructions, and training requirements focusing on customer service, production, and quality.  
• Ensures documentation and physical product segregation and containment of non-conforming material. 
• Reviews production documentation for accuracy, completeness, and GDP compliance.  
• Communicates issues / concerns to area owner and direct supervisor or manager.  
• Assist with ensuring a state of “audit readiness” at all times. 
• Follows applicable safety procedures.
• Document any deviations or non-conformances, following Avantor procedures and Work Instructions, encountered during routine activities.
• Assist in resolving basic quality issues under supervision.
• Collect data for quality reports.
• Order supplies for the quality department when needed.
• Ensures cleanliness of work areas. 
• Performs other duties as assigned. 

What we’re looking for: 

• Education:

• High School completion or equivalent (GED) required.

• Experience:

• A minimum of 1-year related experience and/or training in a regulated industry is preferred.

• Experience in a Quality role within the medical device, biotech, or pharmaceutical industry is preferred. 

• Additional Qualifications:

• Good communication, written skills, and interpersonal skills. 
• Good attention to detail.
• Ability to read, understand, and follow procedures. 
• Ability to escalate issues according to established procedures.
• Familiarity with Quality Management Systems.
• GMP knowledge is preferred.
• Self-motivated and ability to work independently and with a team.
• Knowledge and experience utilizing Microsoft Outlook, Word, Excel, and Access, or equivalent software packages.
• Good mathematics skills.
• Basic understanding of quality standards such as ISO 9001.
• Documentation skills to accurately record test results and quality issues.

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 [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 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.