Quality Agreement Specialist

Avantor; Bridgeport (NJ); On-site; USD 63,000 - 101,000; Full time

Job summary

Avantor seeks a Quality Agreement Specialist to support QA operations, ensuring CGMP alignment, regulatory compliance, and continuous process improvement. You will draft, maintain and negotiate Customer Quality Agreements with cross-functional teams, and respond to technical inquiries across Avantor's pharmaceutical and laboratory lines.

You will interact with Marketing, Sales and QA to design efficient data collection and archiving, contribute to lean initiatives, and support audits and

Qualifications

• BS/BA in Biology, Biotechnology, Bio Engineering, Chemistry, Chemical Engineering, or related field required.
• Minimum of three (3) years of combined experience in technical services, engineering, quality or sales in chemical or pharmaceutical environment.
• Familiar with cgMP, FDA, ICH and WHO guidelines and quality/validation processes.
• Excellent knowledge of Microsoft Office; aptitude to learn databases and other applications.

Responsibilities

• Manage and negotiate Customer Quality Agreements with Avantor's legal team.
• Respond to customers' technical and quality inquiries about pharmaceutical and laboratory product lines.
• Research technical documents, review specifications, and prepare quality agreements.
• Design/improve quality information collection and archiving with cross‑functional teams.
• Participate in lean process reviews to maximize team efficiency in responses.
• Collaborate on cross-functional customer intimacy programs and support projects.
• Travel up to 10% as required.

Skills

Quality assurance

Regulatory knowledge

Project management

Customer communication

MS Office & databases

Education

BS/BA in Biology, Biotechnology, Bio Engineering, Chemistry, Chemical Engineering, or related field

Tools

Microsoft Office Suite

Database systems

Job description

Avantor is looking for a Quality Agreement Specialist to join us! The Specialist supports quality assurance operations by ensuring compliance with standards and regulations, contributing to testing and process improvements, supporting audits and corrective actions, and collaborating with internal teams and suppliers to resolve quality issues.

This is a full-time role based in either Phillipsburg or Bridgeport, New Jersey.

What we're looking for

• Education: BS/BA Degree in Biology, Biotechnology, Bio Engineering, Chemistry, Chemical Engineering, or related field required
• Experience: Minimum of three (3) years of combined experience in technical services, engineering, quality or sales in chemical or pharmaceutical environment required
  • Synthetic pharmaceutical & biopharmaceutical drug development and manufacturing as well as an understanding of industry regulations (cGMP, FDA, ICH, and WHO), quality and validation.
  • Quality and process engineering in a chemical or pharmaceutical environment.
• Collaboration Tool: Excellent knowledge of Microsoft Office Suite; experience working with other computer applications (such as databases) with an aptitude to further develop technical skills preferred
• Preferred Qualifications:
  • Hands-on experience in a laboratory or manufacturing environment
  • Project management experience
  • Experience in at least one of the following areas is highly desired

How you will thrive and create an impact

The Quality Agreement Specialist provides technical and quality support to Avantor's global customer and sales organizations. This role partners with internal teams to research, compile, and communicate information related to Avantor's pharmaceutical and laboratory product offerings. The Specialist is also responsible for developing and maintaining quality documentation, updating product and customer databases, and managing customer Quality Agreements.

• Manage and negotiate Customer Quality Agreements in collaboration with the Avantor legal team.
• Responds to customers' technical and quality inquiries (via telephone and email,) pertaining to the Company's pharmaceutical and laboratory product lines which includes excipients, bio reagents, salts, sugars, acids, cGMP-manufactured solutions and chromatography media as they relate to quality agreement support.
• Researches technical documents, reviews product specifications, and utilizes resources such as technical monographs, Company R&D experts, in-house databases and personal technical background to prepare quality agreements and communicate information to customers.
• Participates in designing/improving quality agreement information collection and archiving processes with other departments including but not limited to Marketing, Sales, and Quality Assurance.
• Participates in lean principles review of processes in order to maximize team efficiency in customer responses.
• Participates as part of cross functional team associated with the customer intimacyprograms; responsibilities may include project management, data collection and review, hosting and participating in recurring meetings.
• Performs other duties as assigned with or without accommodation.
• Ability to travel upwards of 10%.

KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)

• Demonstrated ability to manage multiple priorities in a fast-paced environment while keeping customers' needs in mind.
• Results-oriented, energetic, self-motivated, and a dedicated team player.
• Proven problem solving and leadership skills.
• Exhibits initiative, attention to details and follow-through.
• Ability to learn industry regulations and Avantor's proprietary systems.
• Committed to the highest standards of customers satisfaction and providing the ultimate customer experience.
• Excellent verbal, written skills in addition to presentation and interpersonal communication skills.

ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions)

The work environment is an office setting.The duties of the job may require the Quality Agreement Specialist to go to the manufacturing facility and R&T building on occasion. Occasional travel may be required both domestically and internationally.

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.

Pay Transparency

The expected pre-tax pay for this position is

$62,500.00 - $100,625.00

Avantor offers a comprehensive benefits package including medical, dental, and vision coverage, wellness programs, health savings and flexible spending accounts, a 401(k) plan with company match, and an employee stock purchase program. Employees also receive 11 paid holidays, accrue 18 PTO days annually, are eligible for volunteer time off and 6 weeks of 100% paid parental leave (except in states that offer paid family leave). These benefits may not apply to employees covered by a collective bargaining agreement or those subject to other eligibility rules.

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 [e-mail] 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.