Quality Assurance Specialist

Avantor•Devens, MA

2d•$45,500 - $79,500•Onsite

About The Position

The Opportunity: 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.

Requirements

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.
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.
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.

Nice To Haves

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

Responsibilities

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.

Benefits

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!
The expected pre-tax pay for this position is $45,500.00 - $79,500.00 Actual pay may differ depending on relevant factors such as prior experience and geographic location.