Manager, Quality Assurance

The Quality Assurance Manager (Manufacturing) is responsible for oversight of quality assurance activities related to the business operations units, as defined by the quality management system, applicable FDA regulations, ISO requirements, current and future certifications / accreditations and Management.

The QA Manager will provide support and guidance to Quality Assurance associates. Advises Management on necessary continuous improvement efforts so that systems and processes are in line with overall company strategy, voice of the customer, regulatory standards, guidelines and quality policy. Strategically provides technical input and advises / implements necessary process and documentation changes and makes decisions based on customer, associate and company best interests.

This is an onsite position at our Phillipsburg, NJ site.

• Manages and provides direction to Quality Assurance department and associates.

• Trains, motivates, monitors and evaluates performance of Quality Assurance associates.

• Direct CAPA program for business operations units (currently knows as NCR) are performing effectively and timely.

• Conduct internal audits for Quality Management System

• Provide technical support regarding the revision or implementation of process documentation, including procedures, work instructions, and forms.

• Have working knowledge of and support compliance with IPEC and FDA Quality System Regulations (QSR); Maintain the integration of FDA regulations, and any other regulatory bodies, into the Quality Management System (QMS). 

• Provide strategic insight to senior management.

• Conduct root cause analysis throughout the Manufacturing group.

• Ensure organizational QMS training is in place; provide training as requested. 

• Lead Complaint Investigation efforts. 

• Maintain and manage cGMP at defined levels of compliance.

• Ensure work product and technical reports provide clarity and accuracy.

• Work directly with customers and suppliers to understand and communicate critical features, requirements and corrective actions, as well as supplier approvals and performance.

• Coordinates objectives with production procedures in cooperation with other managers to maximize product reliability and minimize costs.

• Ensures inspection activity for product throughout production cycle.

• Performs other duties as assigned.

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.

The expected pre-tax pay for this position is

Actual pay may differ depending on relevant factors such as prior experience and geographic location.

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 recruiting@avantorsciences.com 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 Know Your Rights poster.

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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.

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.