Senior Quality Assurance 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 Senior Quality Assurance Specialist holds a critical role within the Quality Assurance department, contributing to and driving initiatives for high-profile projects in production environments. This position requires a seasoned professional capable of acting as a key decision-maker and serving as the Quality Manager's designee in their absence. The Senior Specialist is instrumental in advancing the department's goals through expert knowledge, leadership in quality processes, and strategic involvement in continuous improvement practices.

Reporting Relationships

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

Major Duties and Responsibilities

• Executes internal audits as a lead in alignment with the Internal Audit Program to ensure continuous compliance and quality improvement.

• Develops and delivers training to all organizational areas to promote a culture of quality and improvement.

• Reviews in-process/final documentation for adherence to Good Documentation Practices and Data Integrity.

• Reviews validation protocols and reports, ensuring quality standards are met.

• Initiates and participates in systems for identifying and resolving quality issues and enhancing process efficiency.

• Provides guidance on quality assurance practices to operational teams.

• Coordinates supplier audits and addresses quality issues to maintain supply chain integrity.

• Manages the maintenance and implementation of quality systems, including SOP writing and document control.

• Offers analyses of QA guidance to support organizational strategic initiatives and compliance.

• Maintains regular and reliable attendance.

• Upholds and adheres to the Tosoh Bioscience culture and guiding principles.

• In addition to the duties listed, performs all responsibilities inherent to the Quality Assurance Specialist Role, ensuring seamless integration and comprehensive coverage of the quality assurance function.

Education

Bachelor of Science degree in Biology, Chemistry, or a related biotechnology field with at least 5 years of relevant industry experience, or a Master’s degree in a related field.

Skills and Qualifications

• Expertise in Quality Management Systems and relevant regulatory requirements specific to the pharmaceutical biomanufacturing industry

• Strategic problem-solving, demonstrating the ability to conduct complex investigations, with a strong emphasis in critical thinking and problem-solving skills.

• Ability to manage multiple priorities, coordinate projects, and meet deadlines in a dynamic environment.

• Experience with instrumentation, including but not limited to, calibration, maintenance, and validation processes, is desirable.

• Effective oral and written communication skills capable of effectively conveying information across all organizational levels.

• Comprehensive understanding of audit methodologies and quality standards

• Proficient in identifying, evaluating, and prioritizing risks

• Ability to engage and educate audiences, facilitating sessions that encourage participation and knowledge retention.

• Capability to inspire and motivate employees towards embracing quality improvement initiatives and maintaining high standards of compliance.

• Technical expertise in quality assurance processes

• Strong communication and interpersonal skills

• Ability to follow instructions and work independently

• Ability to navigate computer software and store documents in an electronic repository system

• Ability to understand, follow, and draft written procedures.

• Ability to use Microsoft Office Applications

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