Quality Agreement Specialist

About the role

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.

Requirements

• 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

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 which includes 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 but not limited to Marketing, Sales, and Quality Assurance
• Participate in lean principles review of processes in order to maximize team efficiency in customer responses
• Participate 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
• Perform other duties as assigned with or without accommodation
• Ability to travel upwards of 10%

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, written skills in addition to presentation and interpersonal communication skills

Working Conditions

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.

Pay

The expected pre-tax pay for this position is $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
• Accrue 18 PTO days annually
• Eligible for volunteer time off
• 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.