Quality Agreement Specialist

vwr; Phillipsburg (NJ); On-site; USD 75,000 - 95,000; Full time

Job summary

Avantor is seeking a Quality Agreement Specialist to support QA operations, ensure regulatory compliance and drive quality improvements. The role collaborates with internal teams and suppliers to resolve quality issues and develops quality documentation and customer agreements.

Based in Phillipsburg or Bridgeport, NJ, it offers full-time employment with travel up to 10%. The ideal candidate has a BS/BA in a related science, 3+ years in chemical/pharma environments, and experience with cGMP, FDA,

Qualifications

• BS/BA degree in Biology, Biotechnology, Bio Engineering, Chemistry, Chemical Engineering, or related field required.
• Minimum of three years of experience in technical services, engineering, quality or sales in chemical or pharmaceutical environments.
• Experience in synthetic pharmaceutical & biopharmaceutical development and manufacturing and understanding of industry regulations (cGMP, FDA, ICH, WHO).
• Quality and process engineering experience in chemical or pharmaceutical environments.
• Proficiency with Microsoft Office; experience with databases and ability to develop technical skills.
• Hands-on laboratory or manufacturing experience is preferred.
• Project management experience is desirable.
• Experience in at least one of the following areas is highly desired.

Responsibilities

• Provide technical and quality support to Avantor's global customer and sales teams.
• Research, compile and communicate information related to Avantor's pharmaceutical and laboratory product offerings.
• Develop and maintain quality documentation; update product and customer databases; manage customer Quality Agreements.
• Manage and negotiate Customer Quality Agreements with Avantor legal team.
• Respond to customers' technical and quality inquiries via telephone and email related to product lines and quality agreement support.
• Review technical documents and product specifications; use monographs, R&D experts, internal databases to prepare quality agreements.
• Design/improve quality agreement information collection and archiving with Marketing, Sales, and Quality Assurance.
• Participate in lean process reviews to maximize team efficiency in customer responses.
• Participate on cross-functional teams for customer intimacy programs; may include project management and data handling.
• Perform other duties as assigned; travel may be required.

Skills

Quality assurance

Regulatory knowledge

Project management

Problem solving

Education

BS/BA degree

Tools

Microsoft Office Suite

Databases

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 intimacy programs; 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.

#LI-Onsite

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 th