Quality Supervisor

Quality Supervisor

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 Supervisor is responsible for overseeing Quality Control and laboratory functions at Colorcon's Belen site. This role is responsible for managing the site's Quality Control team, in addition to the maintenance and operation of laboratory equipment, including calibration.

Responsibilities & Duties

• Develop new Quality Control (QC) methods and optimize existing methods to ensure accurate analytical results.
• Implement required analytical methods from the Development & Application department and USP test standards.
• Responsible for all incoming, in-process, and outgoing quality control, including data integrity validation per ALCOA.
• Represent the Quality Control (QC) department during internal and external audits.
• Manage customer and supplier complaints (QNS) and ensure CAPA effectiveness.
• Monitor and stop production as warranted, based on quality standards and procedures.
• Maintain archive batch files and retain samples.
• Provide technical support to production.
• Translate customer specifications into internal specifications.
• Responsible for calibration and maintenance of all site measuring and test equipment.
• Ensure required calibration of laboratory instrumentation is carried out according to schedule.
• Maintain the Quality module for materials in SAP, including material inspection plans, certificate profiles, and master characteristics.
• Ensure Quality Control compliance for batch release.
• Create and maintain all QC documents in the company document management system.
• Ensure environmental monitoring is performed per operating procedures.
• Ensure EHS compliance for the QC team.
• Maintain the non-conformance process and ensure operating instructions are implemented and followed.
• Manage quality staff (direct reports) to ensure efficient and timely service to internal and external customers.
• Responsible for the development and training of the Quality Control team.
• Support the Quality team during the absence of the Quality Manager.
• Pilot change control and follow up as needed.
• Liaise with other departments as required.
• Perform other duties as assigned.

Minimum Qualifications

• Bachelor's degree in Quality or a physical science, or Associate's degree with a minimum of five (5) years of quality experience in a manufacturing environment required.
• Minimum of five (5) years of leadership or supervisory experience in a Quality Department required, preferably in manufacturing.
• Experience with ISO 9001, ISO 14001, OHSAS 18001, ISO 15378, or GMP is a plus.
• Demonstrated leadership skills and ability to act as a resource for inspectors and production personnel.
• Basic mathematical skills and ability to work with written instructions required.
• Ability to write and verbally communicate data, reports, and various laboratory documents and correspondence.
• Proficiency with quality terms, definitions, and concepts to drive continuous improvement.
• Demonstrated ability to work with various laboratory and office equipment.
• Proven ability to work with Microsoft Office applications, including Excel, PowerPoint, and Outlook.
• Ability to effectively communicate with peers and other departments and demonstrate strong teamwork.
• Metrology knowledge and experience preferred.
• Lean or Six Sigma certification or training preferred.

Location:

101 Christine Drive

Belen, New Mexico, 87002

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.