Quality Agreement Specialist

About the role

Full-time position based in Phillipsburg or Bridgeport, New Jersey. The Quality Agreement 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. The role provides technical and quality support to Avantor's global customer and sales organizations, partners with internal teams to research, compile, and communicate information related to pharmaceutical and laboratory product offerings, develops and maintains quality documentation, updates product and customer databases, and manages customer Quality Agreements. Ability to travel upwards of 10%.

Requirements

• BS/BA Degree 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 required
• Synthetic pharmaceutical & biopharmaceutical drug development and manufacturing experience, with understanding of industry regulations (cGMP, FDA, ICH, and WHO), quality, and validation
• Quality and process engineering experience in a chemical or pharmaceutical environment
• Excellent knowledge of Microsoft Office Suite; experience working with other computer applications (such as databases) with 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

Responsibilities

• Manage and negotiate Customer Quality Agreements in collaboration with the Avantor legal team
• Respond to customers' technical and quality inquiries (via telephone and email) pertaining to the Company's pharmaceutical and laboratory product lines including excipients, bio reagents, salts, sugars, acids, cGMP-manufactured solutions, and chromatography media as they relate to quality agreement support
• Research technical documents, review product specifications, and utilize 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
• Participate in designing/improving quality agreement information collection and archiving processes with other departments including Marketing, Sales, and Quality Assurance
• Participate in lean principles review of processes to maximize team efficiency in customer responses
• Participate as part of cross-functional team associated with customer intimacy programs; responsibilities may include project management, data collection and review, hosting and participating in recurring meetings
• Perform other duties as assigned with or without accommodation

Skills

• 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 customer satisfaction and providing the ultimate customer experience
• Excellent verbal and written skills in addition to presentation and interpersonal communication skills

Working Conditions

The work environment is an office setting. The duties 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.

Pay

Expected pre-tax pay range: $62,500.00 - $100,625.00. Actual pay may differ depending on relevant factors such as prior experience and geographic location.

Benefits

• Medical, dental, and vision coverage
• Wellness programs
• Health savings and flexible spending accounts
• 401(k) plan with company match
• Employee stock purchase program
• 11 paid holidays
• 18 PTO days accrued annually
• Volunteer time off
• 6 weeks of 100% paid parental leave (except in states that offer paid family leave)

Benefits may not apply to employees covered by a collective bargaining agreement or those subject to other eligibility rules.