Quality Control Technician, 1st shift

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 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
• 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.

Responsibilities & Duties:

• Identify quality principles related to products and processes (monitoring, measuring, continuous improvement).
• Define & apply continuous improvement techniques- Lean mfg., 8D, PDCA, etc. to solve quality problems.
• Apply structured meeting management techniques - creating & following an agenda, minutes, ground rules.
• Document Control - Create and update GMS documents including SOP and Work Instructions.

Statistical techniques

• Define & determine the applicable statistical technique in various situations (calculations, charts)

Regulatory

• Drug Master File and Letters of Authorization Management with 3rd party and customers
• Manage regulatory requests from customers.
• Customer and ISO Audit management - Scheduling, CAPA, follow-up, and Reports
• Assist with Quality Agreements, Questionnaires, and subtler supplier change control.
• Manage MICRO testing, pest control, cleaning validations, recall, and purchasing for Quality Dept.

General Quality Team Support

• Perform tests (following a protocol) and make the report with conclusion.
• Prepare Inspection plans and instructions.
• Certificate of Analysis & Certificate of Compliance management.
• SAP master data for quality - update and assist management.

CAPA - Corrective and Preventive Action

• Identify and apply corrective and preventive methods for products and processes.
• Assist QNS coordinator to open, investigate and close customer and supplier complaints.

Additional Responsibilities:

• Customer correspondence - verbal and document
• Assist with Internal & External Audits
• Liaison with other departments and customers

• Associate's Degree Preferred, or ASQ Certification, or equivalent experience
• 1-3 years in similar position
• Excellent teamwork, PC Communication skills, basic statistics, math, write reports, ability to communicate with other departments.

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.