Quality Assurance Specialist – 1St Shift

Job Summary

Avantor is looking for a dedicated Quality Assurance Specialist to optimize our Biopharma team. This position is 1st shift, Monday thru Thursday, 5:30 AM to 4:00 PM.
This role will be a full-time position based out of our Devens, MA facility. If you have experience in customer and regulatory requirements by inspecting products and review of documentation throughout all aspects of the production process, compliance with all applicable standards and regulations, Good Manufacturing Practices (cGMPs), and Good Documentation Practices (GDPs) and provide event and complaint investigation support to other team members. – let’s talk!

What we’re looking for 

• Basic knowledge of operating standard office equipment (printer, scanner, etc.) is preferred
• Knowledge of ISO 9001, ISO 13485, 21 CFR 820, 21 CFR 11, ISO 17025, or EXCiPACT standard is preferred
• Education: High School completion or equivalent (GED) is required
• Detail oriented is preferred
• Good communication skills, both oral and written is preferred
• Strong interpersonal and critical thinking skills is preferred
• Strong organizational skills is preferred
• Collaboration Tool: Knowledge and experience utilizing Microsoft Outlook, Word, Excel, and Access, or equivalent software packages is required 
• Certification(s):
• Ability to multi-task, prioritize, manage time, problem solve, and work as part of a team are crucial is required
• Experience: Minimum of 3 years related experience and/or training in a regulated industry is required OR Bachelor’s degree is required
• Preferred Qualifications:  Experience in a Quality Assurance role within the medical device, biotech, GMP regulated environment or pharmaceutical industry is preferred

How you will thrive and create an impact 
Documentation (GMP/GDP) Duties:

• Looks for improvements in all quality-related areas. Initiates proposals for improving existing systems.
• Uses safe work methods and respects safety rules, policies and procedures.
• Maintains records of employee training, as well as identifying relevant quality-related training needs and delivering said training.
• Manages the company’s production documentation folders and files.
• Produces and reviews manufacturing documentation prior to release to production, including Job Travelers, Assembly Protocols, Certificates of Compliance and labels.
• Performs other duties as assigned.
• Performs batch record review and manufactured product release.
• Performs internal auditing of non-quality related business practices.

Inspection Duties:

• Complies with company policies, procedures, work instructions, and training requirements focusing on customer service, production, and quality.
• Performs other duties as assigned.
• Documents non-conformances following applicable Avantor procedures and work instructions.
• Ensures documentation and physical product segregation and containment of non-conforming material identified during the production process.
• Performs inspection tasks by following established work instructions and procedures, by using required tools and methods and, when applicable, equipment, to determine acceptability of product, components, and documentation.
• Keeps customer interests and regulatory requirements in mind, ensures customer needs are met by reviewing order requirements, customer documentation requirements, proper filling and assembly requirements, and, where needed, ensures other technicians understand and follow documented Avantor procedures and GMP requirements.
• Verifies adherence to policies, procedures, and work instructions.
• Stops production when a non-conformance (NCM) is observed and follows appropriate NCM procedures.

ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions)

• While performing the duties of this Job, the employee is occasionally exposed to fumes or airborne particles and toxic or caustic chemicals.
• Works on the production floor with adequate lighting and ventilation with occasional elevated noise levels and a varying range of temperatures.
• A frequent volume of work and deadlines impose strain on routine basis.
• Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems.
• Minimal physical effort is required; however, the position does require frequent walking, standing, bending, reaching, lifting or possibly carrying objects weighing up to 50 lbs.

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! 

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.

EEO Statement:
We are an Equal Employment/Affirmative Action employer. 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.