SGS is the world's leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 89,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.
As the Quality Assurance Manager, you will lead the ISO/IEC 17025 and 21 CFR, Parts 11, 210, 211, 610, and 820 Quality System at SGS Polymer Solutions as a system of continuous improvement. This position is responsible for ensuring IT, Facilities, and the Labs are 21 CFR Part 11 Compliant during the equipment qualification process and through regular data integrity audits. In addition, you will ensure that all registrations and certifications for the lab remain current.
- Lead the ISO/IEC 17025 and 21 CFR, Parts 11, 210, 211, 610, and 820 Quality System at SGS Polymer Solutions as a system of continuous improvement
- Responsible for ensuring IT, Facilities, and the Labs are 21 CFR Part 11 Complaint during equipment qualification process and through regular data integrity audits
- Ensure that all registrations and certifications for the lab remain current
- Give leadership and develop the quality system with the Qualtrax Document Management System as a tool for achieving ISO/IEC 17025 requirements and the cGMP compliance at PSI
- Provide quality approval for all documentation related to work instructions
- Provide one of two approvals for all approvals related to Quality Procedures or major system changes
- Lead and administrate the Qualtrax Document Management system
- Oversee the schedule, training, execution and, closing of the Internal Audits each year
- Oversee all non-conformances resulting from Internal and External Audits, Complaints, OOS’s and any other investigations ensuring that the system is suitable for compliance and business practice
- Execute all quality agreements or quality surveys sent by the customer
- Lead all customer audits, or regulatory body audits representing Polymer Solutions Incorporated and providing the required documentation, interaction, and completion of any resulting actions
- Interact with PSI staff as necessary to ensure that all quality requirements are understood and executed through effective communication and training
- Oversee the Quality Control System including leadership of any changes or improvements
- Bachelor’s degree in Chemistry or a related field.
- Minimum 5 years of experience in a Quality Assurance role.
- 4 years of experience in Chemistry or a related field
- Experience working in an ISO/IEC 17025 and/or cGMP environment
- Experience working in an FDA regulated environment
- Experience with pharmaceutical and medical device manufacturer or testing
SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.
This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company’s rights to assign or reassign duties and responsibilities to this job at any time.
If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.