Quality Assurance Engineering Manager jobs in Barrington, NJ

Manager, Quality Assurance

Colorcon is a world leader in the design and development of specialty excipients for solid oral dosages for the pharmaceutical and nutritional industries. We deliver superior product quality, unparalleled technical support, extensive regulatory assistance, and reliably supply from multiple locations, with our Global Headquarters located in Harleysville, Pennsylvania.

We are a successful company thanks to our diverse workforce and global reach. We believe that our operating principles define our culture, values and organizations and are key to achieving our mission and vision, strategies and goals

Platinum Rule: We treat others the way we want to be treated
Empowerment: We trust our colleagues with responsibility and decision-making
Keep Getting Better: We create an environment for constant improvement, to be the best we can
Teamwork: We embrace the value of collaboration; work together to exceed what is possible as individuals
Customer Focus: We put our customers’ needs at the heart of everything we do
Global Respect: We are citizens of a diverse world and behave with respect for the communities in which we operate

Our People Enjoy a Wide Offering of Employee Benefits, including but not limited to:

• All employees are eligible to participate in our company-wide bonus program
  
• Employees have the choice between three medical plans
  
• 100% company-paid Dental Insurance for all employees and their qualifying dependents
  
• Optional Vision Coverage
  
• Fitness and Wellness Programs
  
• Employee Assistance Programs (EAP)
  
• Corporate Social Responsibility Groups (CSR)
  
• Parental Leave
  
• Tuition Reimbursement; up to $8,000 per calendar year
  
• 401(k) Company Matching
  
• Employees earn up to 17 days of PTO in their first year
  
• Nine Paid Holidays, plus One Personal Holiday for employees to assign at their choosing

Colorcon is committed to maintaining a diverse workforce and an inclusive and equitable work environment. This includes all employment-related decisions and business dealings on the basis of race, color, ethnicity, national origin, age, sex, sexual orientation, religion, disability, veteran status, or any other legally protected status.

The Quality Assurance Manager is responsible for daily management of the Quality Management System, the Quality Assurance Department (Product Release) and other related Quality Assurance maintenance/improvement responsibilities. This position reports to the Site Director, West Point and Puerto Rico. This position has dotted line responsibilities for the Humacao, Puerto Rico Quality Management System.

Responsibilities & Duties

• Daily management of the Quality Management System (QMS) and Food Safety System (FSS).
• Act as site quality representative in all regulatory and certification audits.
• Effectively consult other regional site QMS related activities and events.
• Partner with regulatory, quality control, operations, engineering, maintenance, safety and supply chain departments to optimize and maintain quality management system processes.
• Effectively manage multiple on-going projects to facilitate impactful project development and completion.
• Oversee daily operation of the Product Release and Quality Compliance Teams.
• Serve as a back up to Quality Compliance Specialists, Quality Investigators, and Quality Assurance Supervisor.
• Lead Quality Management System optimization projects related to quality systems creation, updates and/or removal of internal systems.
• Foster collaborative relationships focused on product quality and process quality to ensure continual compliance with internal, regulatory, and statutory requirements.
• Participates in regional/global collaborative projects designed at enhancing the synergies of multiple Quality
• Management Systems.
• Effectively communicate all department and company policies as they relate to the daily maintenance of the Quality Management System.
• Manage all daily Site Management Team responsibilities (i.e. meeting representative, project lead, etc.)
• Act as Quality Assurance Representative on regional quality assurance initiatives

• Bachelor’s degree and/or a minimum of five (5) years of Quality Assurance experience required.
• Minimum of 2 years supervisory experience in Quality and/or hold a recognized Quality Management Certification required (i.e. CMQ/OE)
• Previous GMP manufacturing experience required.
• Minimum of 1 year of ERP System experience required.
• Project Management Certification(s) preferred.
• Ability to communicate effectively at all levels of the organization, both verbally and in written reports.
• Experience in technical writing strongly preferred.
• Consistent attention to detail.
• Proven track record of strong time management, organizational, and decision-making skills required.
• Prior experience in problem solving techniques highly desirable.
• Ability to work comfortably in the manufacturing area.

Location:
420 Moyer Blvd
North Wales, Pennsylvania, 19044
United States

Colorcon participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, this employer is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue before the employer can take any action against you, including terminating your employment. Employers can only use E-Verify once you have accepted a job offer and completed the Form I-9.
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For more information on E-Verify, or if you believe that your employer has violated its E-Verify responsibilities, please contact DHS.