Quality Assurance Investigator

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.

Position Summary
The Quality Assurance Investigator performs quality-critical activities that ensure products and processes meet Colorcon’s quality standards while meeting Colorcon’s internal, regulatory, and certification commitments. This position reports to the Quality Assurance Manager, with responsibilities of the role shared amongst all Quality Assurance Investigators.

Responsibilities & Duties

• Manage Non-Conformance Issues in Colorcon's Customer Support Solution (CSS) (Supplier, INC, etc.)
• Manage electronic storage of quality related records.
• Actively promote GMP awareness at all levels within the company.
• When necessary, participate in third party certification audits.
• Internal Quality Investigations:
  
  • Responsible for initiating INC Service Requests (SRs) and determining appropriate corrective actions to prevent reoccurrence.
  • Partner with quality control, operations, engineering, maintenance, safety and supply chain to ensure appropriate and timely determination of scope, product impact, root cause of product quality issues, INC issues and other manufacturing deviations.
  • Documents all investigation activities in detailed, timely reports utilizing Colorcon’s Customer Support Solution (CSS).
• External Quality Investigations:

• Ensures product and service quality complaints are thoroughly investigated within prescribed timelines and investigations are adequately documented. This involves initiating and participating in cross functional team investigations of product concerns, evaluating current inventory, and confirming in any corrective or preventative actions resulting from the investigation are completed in a timely manner.

• Works collaboratively with internal departments such as customer service, quality control, engineering, manufacturing, and purchasing to investigate product/service issues or concerns.
• Communicates directly with customers regarding product and service quality complaints.

• Support Product Release activities (wet/dry/lake/pvap/raw material) when applicable.
• Other quality assurance related tasks, as necessary.

• Bachelor's degree in a scientific discipline and/or a minimum of 3 years of quality auditing or laboratory experience required.
• Ability to work comfortably in the manufacturing area.
• Recognized Quality Certification, preferred with willingness to obtain a certification required.
• Demonstrated professional verbal and written communication skills.
• Exceptional organizational, analytical, and computer skills.
• Consistent attention to detail.
• Flexible, self-starter with the ability to work well both independently and in a team setting.

Working Location

• Position is based in West Point, PA with the availability for a hybrid schedule.
• Working remotely from a home office will be facilitated when applicable and is at the manager’s discretion.
• Travel: 5% Domestic and International Travel Required

Location: 420 Moyer Blvd, North Wales, PA 19486