Quality Assurance Auditor I

Colorcon® is a world leader in the development, supply and technical support of formulated film coating systems, modified release technologies, specialty excipients and functional packaging for the pharmaceutical, nutritional, and animal health industries. Our best-in-class products and technologies are complemented by our extensive formulation experience, application data and value-added services to support all phases of solid oral dose design, development, and manufacture.

Our focus on market issues and technology development has earned Colorcon an international reputation as a pharmaceutical supplier of choice. That reputation is based on superior product quality, unparalleled technical support, extensive regulatory assistance and reliable supply from multiple locations, with our Global Headquarters located in Harleysville, Pennsylvania.

Colorcon has 26 technical service laboratories globally and more than 2100 employees exclusively dedicated to its customer base.

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 they 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
• Paid Time Off
• Paid Holidays
  
  
  

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.


Position Summary

The Quality Assurance (QA) Auditor I is responsible for batch review and release and assists in investigation of reported product quality issues and internal non-conformance issues. The QA Auditor I is also responsible for meeting all other tasks assigned via their yearly goals set by the Quality Manager. The position reports to the Quality Manager.


Responsibilities & Duties

• Aware of GMPs and GLPs and maintains compliance with those regulations
• Performs batch review and product release activities for the Indianapolis site
• Prepares paperwork for samples being sent to the QC laboratory.
• Supports sending samples for external testing.
• Assists with internal quality audits
• Perform quality review/audit of incoming raw materials and finished products.
• Supports the investigation of customer reported product quality issues, internal non-conformance (INC) issues and other manufacturing deviations or problems.
• Partners with quality control, operations, engineering, maintenance, safety and supply chain to ensure appropriate and timely determination of scope, product impact, root cause and corrective actions of product quality issues, INC issues and other manufacturing deviations.
• Fosters collaborative relationships focused on high quality investigations, meaningful corrective actions and the reduction of INC issues.
• Documents all investigation activities in detailed, timely reports utilizing Colorcon’s Customer Support Solution (CSS).
• Responsible for initiating INC service Requests (SRs)
• Issue necessary quality paperwork for SR related operations.
• Assists with new hire training for employees
• Assists with document retention.
  
  
  
  

Required Qualifications:

• Bachelor’s degree in a physical science preferred or a minimum of 2 years quality auditing experience required.
• Ability to work comfortably in the manufacturing area.
• Ability to communicate effectively at all levels verbally and in written reports.
• Experience in technical writing strongly preferred.
• Consistent attention to detail.
• Excellent organizational and decision-making skills.
• Prior experience in problem solving techniques highly desirable.
  
  
  

Location:

3702 E. 21st St

Indianapolis, Indiana, 46218

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.

E-Verify Works for Everyone

For more information on E-Verify, or if you believe that your employer has violated its E-Verify responsibilities, please contact DHS.