Location: Stoughton,WI, USA
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.
The Quality Supervisor (Stoughton) is responsible for supervising and leading the quality of the product supplied from the Stoughton manufacturing facility as well as any development, implementation and maintenance of the site's Quality Systems that may be required. The position has direct responsibility for the site's Quality team for Quality Control and Quality Assurance. This position reports directly to the Site Manager for the Stoughton site.
Required Qualifications:
* Provide supervision, direction, training and mentorship to the Stoughton Quality Department.
* Oversee the Quality department budget development and oversight.
* Oversight of local Quality systems, policies, and procedures to ensure consistency Colorcon global standards.
* Support the ongoing effort to transform processes and employee mindset to drive efficiency and effectiveness while mitigating risk throughout the quality organization.
* Coordination and hosting of customer and regulatory audits.
* Ensure compliance with cGMPs and ensure all activities associated with cGMP compliance are properly documented.
* Leadership and execution of GMP training.
* Correspond with external customers concerning product and technical issues (customer specifications, customer GMP/Quality questionnaires, technical assistance, and customer complaints).
* Provide support in Quality related matters to customers, agents/distributors, and internal employees.
* Supervise the development of and training on analytical test methods, laboratory operating instructions and standard operating procedures.
* Coordination of validation protocols and technical reports for the site.
* Liaise with Operations, Technical and other Quality managers to identify problems and potential areas for improvement.
* Lead and implement continuous improvement programs within Quality as well as support other areas.
* Partner with the Site Manager, Global Quality and Regulatory Services to ensure global QA policies are maintained and implemented in Stoughton.
* Keep up to date with developments in Quality Assurance and Quality Management Systems.
Minimum Qualifications
* Bachelor's degree in one of the physical sciences with at least 3 years of quality experience required.
* Minimum of 1 year of supervisory / management experience required; strongly preferred in a Quality Lab environment.
* Must have experience with analytical chemistry, instrumental analysis, and data compilation.
* Previous experience in the pharmaceutical or related industries required.
* Auditing experience required with certification preferred.
* Must have strong technical writing skills, with experience preparing validation protocols, technical reports, procedures.
Working Location
* This position is an on-site role, based at Colorcon's Stoughton, WI manufacturing site.
* Working remotely from a home office will be facilitated when applicable and is at the manager's discretion.
* Travel: Up to 10% annual travel may be required.
Location:
440 Business Park Circle
Stoughton, Wisconsin, 53589
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.
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For more information on E-Verify, or if you believe that your employer has violated its E-Verify responsibilities, please contact DHS.