Manager, Quality Assurance

Avantor•Phillipsburg, NJ

3d•Onsite

About The Position

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.

Requirements

Bachelor’s Degree in a life science discipline, or an equivalent combination of education and experience preferred; formal training and/or advanced courses are preferred
5+ years progressive work experience in Quality Systems, combined with a demonstrated record of accomplishments as a Quality professional, and with strong customer orientation in a similar industry; previous supervisory experience preferred
Must be familiar with relevant regulations
Strong knowledge of FDA and international Quality System rules and regulations
Strong oral and written communication skills
Strong interpersonal and organizational skills
Ability to take initiative, maintain confidentiality, meet deadlines, and lead people in a team environment essential
PC skills required (MS Word, Excel, PowerPoint, Access)

Responsibilities

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.