Quality Management System Specialist

Description

Tosoh Bioscience LLC is a major supplier of chromatography products to the pharmaceutical, biotechnology, and chemical industries. Our product line includes:TSKgel®, TOYOPEARL®, and Ca Pure-HA® bulk media, TSKgel U/HPLC columns, process development products, dedicated systems for GPC analysis, and the LenS3™ MALS detector. We have optimal solutions for biological research, drug discovery, medicinal chemistry, agriculture, manufacturing, or other industrial applications.

Summary

The Quality Management Systems Specialist plays a key role in ensuring the ongoing development, implementation, and management of the Quality Management System (QMS). This position ensures that quality systems, including the Electronic Quality Management System (eQMS), are effectively integrated, maintained, and continuously improved to meet organizational objectives.

Reporting Relationships

• Reports to the Quality Assurance Manager. This position has no supervisory responsibilities.

Major Duties and Responsibilities

• Lead and manage the implementation and ongoing maintenance of the eQMS. Review system change descriptions, assess risks, and test updated functionality after quarterly eQMS site updates.

• Create and maintain regular reports and metrics for Quality Management Review, tracking the effectiveness of quality systems and continuous improvement efforts

• Conduct routine training sessions for employees to ensure compliance with the eQMS.

• Drive continuous improvement initiatives and assess existing systems for process optimization.

• Collaborate closely with cross-functional teams, including Regulatory, Operations, and IT, to ensure smooth system integration and maintenance.

• Proactively identify and mitigate potential risks in the eQMS, data validation, and system maintenance.

• Provide guidance on operational activities to resolve quality-related issues and promote continuous improvement.

• Ensure the proper documentation, implementation, and maintenance of quality systems, including SOPs, document control processes, and quality records.

• Routinely conduct training sessions with manufacturing and other functional groups as required by quality system actions or for general improvement initiatives

• Review of process documentation in compliance with Good Documentation Practices, Data Integrity, and effective procedures.

• Provide guidance on operational activities.

• Proactively initiate the development of streamlined systems to effectively identify and resolve quality problems and identify process improvement opportunities.

• Review/approve manufacturing records, validation protocols and study reports, stability data, change controls, investigations, and Quality Control data.

• Ensure implementation and maintenance of quality systems, including, but not limited to, SOP writing and document control processes.

• Help manage and maintain the supplier qualification process.

• Escalate potential risks to management during planning, review, data validation, data review, and archival processes.

• Participate in internal and/or external audits, as required.

• Maintain regular and reliable attendance.

• Uphold and adhere to the Tosoh Bioscience culture and guiding principles.

• Other duties as assigned.

Education

• Bachelor’s degree in engineering, biotech, or related field or a minimum of 3 years of quality experience in Quality Systems.

Skills and Qualifications

• 3 years of Quality Assurance experience.

• Strong working knowledge of Quality Management Systems (QMS)

• Effective project management and organizational skills are essential.

• Excellent oral and written communication, interpersonal and organizational skills, and attention to detail.

• Ability to interact effectively with management and prioritize multiple projects.

• Ability to embrace change and multi-task in a fast-paced environment.

• Technical proficiency, effective problem solving and critical thinking skills.

• Ability to consistently deliver under tight timelines and deadlines.

• Ability to work in a team environment.

• Ability and willingness to travel up to 15% of the time.

Physical Requirements

The physical demands of this job are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This is a primarily sedentary job that requires the ability to move to and from the desk and occasionally lift and/or move objects.

Tosoh Bioscience LLC is an Equal Opportunity Employer M/F/Disabled/Veterans

Qualifications