For over 60 years, our client has delivered innovative chemistry and software solutions to solve their customers’ most challenging problems.
Scope: Monitors, maintains, and supports the company’s quality management system (QMS) by conducting audits and implementing continuous improvements. Ensure the established procedures, processes, and controls in all departments are sufficient in providing our customers a high-quality product consistently with no hassles. Evaluate supplier and toll blender processes to ensure uniformity to standards and expectations.
- Continually reviewing the company’s QMS and compliance to ISO and/or GMP.
- Maintain the company’s quality manual and make appropriate changes as needed.
- Establish new policies and procedures to aid in the improvement of the company’s QMS.
- Conduct internal audits and act on the company’s behalf during third-party audits for ISO certifications.
- Conduct personnel training regarding ISO and GMP compliance
- Complete manufacturing and quality-related customer-provided questionnaires.
- Prepare for and act as auditee on the company’s behalf for all customer audits.
- Manage the company’s internal and external audit programs.
- Plan and conduct routine internal audits, prepare reports, report findings, and follow-up on action items.
- Develop and distribute quality questionnaires to suppliers (including toll blenders). Review responses to questionnaires and evaluate supplier performance to determine risk level. Conduct on-site audits accordingly.
- Develop and work to improve internal and supplier performance metrics
- Assist in processing change control requests for any changes to the company’s MRP system.
- Conduct testing and justification needed to make modifications to test methods, testing parameters, testing specification, parts, equipment, software, etc. Compose associated validation reports.
- Serve as a QC back-up for all owned manufacturing locations.
- Conduct reviews of manufacturing and QC records.
- Participate in customer complaints investigations using PDCA cycle and communicate directly with the customer during the process as needed.
- Provide findings including root cause and corrective actions via written reports, both internal and external (customer provided).
- Assist in investigating internal non-conformances to determine the root cause and implement any corrective actions needed.
- Summarize findings in internal reports.
Specification and Tolerance Range Development
- Utilizing Gage R&R, statistical process control, process capability, regression, and other statistical analysis tools to determine the measurement system variation and set acceptable specification or tolerance ranges for new products and equipment.
- Establishing appropriate product shelf life based on stability data review via regression and other statistical analysis techniques.
Toll Blender Site Qualification
- Establishing performance, operational, and installation protocols to aid in qualifying new processes, facilities, equipment, software, etc. Compose associated validation reports.
- Assisting in conducting audits of new toll blender locations to verify a sufficient quality management system is in place and that quality controls are in line.