Quality Assurance Auditor II

Role details

Quality Assurance Auditor II ================================

North Wales, PA, United States \| req577

Posted on: 6/12/2026 Quality Assurance Auditor II

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.

The Quality Assurance Auditor II performs quality-critical activities to ensure our finished products and raw materials meet Colorcon’s quality standards and the requirements of our customers, while meeting Colorcon’s regulatory and certification commitments. This position requires the ability to work independently, take ownership of decisions, and contribute to continuous improvement of quality systems and processes. This role directly reports to the Quality Assurance Supervisor.

Primary Responsibilities & Duties

• Verify that finished products (wet, dry, lake, PVAP) are manufactured and tested in accordance with approved specifications.
• Manage lake and PVAP batch release processes (label generation, closing/approving lots, batch creation, etc.)
• Approve or reject intermediates and finished goods in accordance with approved specifications.
• Verify raw materials and packaging materials are tested in accordance with approved specifications; conduct focused quality reviews of raw material and packaging testing records to verify information from the suppliers’ COA and the work performed by Colorcon Quality Control Scientists.
• Conduct and document supplier and internal non-conformance investigations in CSS, including root cause analysis and support for corrective and preventive actions (CAPAs), as required.
• Conduct real-time auditing of manufacturing activities and focused quality reviews of production records to ensure compliance with SOPs and cGMP.
• Support manufacturing in identifying and resolving quality-related issues.
• Actively support plant and laboratory activities in their respective areas.
• Contribute to the continuous improvement of quality processes and systems.
• Actively promote GMP awareness at all levels within the company.
• Daily/weekly QA representative for all production relevant meetings.
• Manage electronic storage of batch manufacturing records and other quality related records.
• Other quality-related activities as required to support site operations and quality objectives.

Minimum Requirements

• Minimum of an associate’s degree in a scientific or related field with at least two (2) years of quality auditing or laboratory experience required.
• Ability to work comfortably in a manufacturing environment.
• Demonstrated professional verbal and written communication skills.
• Exceptional organizational, analytical, and computer skills.
• Consistent attention to detail.
• Demonstrated ability to make sound decisions in a fast-paced environment.
• Ability to assess risk and prioritize work effectively in a production environment.
• Flexible, self-starter with the ability to work well both independently and in a team setting.

Working location

• Position is 100% on site at the West Point PA location.

Travel:* 5% Domestic Travel Required

Location:

420 Moyer Blvd.

North Wales, Pennsylvania, 19486

United States

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