Quality Systems Specialist III

Описание вакансии

Job Responsibilities:

• Supports management and tracking of quality system records (i.e. Deviation Reports, Corrective and Preventive Actions, and Effectiveness Checks) for adherence to organizational or departmental metric targets and maintenance of associated tracking tools/databases.

• Responsible for sending periodic reminder notifications to leads/coordinators.

• Supports management review process through development and generation of quality system metrics and trending, and escalate issues as required.

• Supports the maintenance and improvement to quality systems processes, as needed

• Works directly with operating entities and internal clients to ensure follow-up of quality issues.

• Support Quality System Governance activities and participation in Governance boards as required.

• Independently conduct, complete, and document deviation investigations or incidents for GxP Quality Systems as required

• Participate in the development and facilitation of training programs related to Quality Systems, including Quality event handling and investigation and development of effective Corrective and Preventative Actions.

• Participate in compliance audits as required.

• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.

• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs).

• Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.

• Creates or enhances tools, templates, and/or best practices aiming at creating efficiency and standardization across the QMS.

• Provides guidance and technical knowledge to more junior staff, monitors the performance of daily tasks.

Basic Qualifications:

Bachelor's Degree and Five Years’ Experience

OR

Masters' Degree and Three Years’ Experience

Preferred Qualifications:

• 5+ years of relevant experience in a GMP environment related field and a BS or BA or 3+ years of relevant experience and a MS.

• Proficiency in Good Manufacturing Practices (GMPs)

• Proficiency in application of QA systems principles, concepts, industry practices, and standards.

• Knowledge of FDA / EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution and maintenance.

• Strong understanding of Quality Systems including Change Control, Deviation, CAPA, and Quality Risk Management.

• Strong knowledge of six sigma, and LEAN principles

• Knowledge and application of risk management principles, including identification, controls, mitigations, and actions.

• Audit and investigation skills, and report writing skills.

• Ability to problem solve and lead process improvements.

• Ability to lead cross-functional meetings and make decisions as QA representative.

• Strong verbal, writing, and interpersonal skills.

• Proficiency in Microsoft Office applications.

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills, experience, aspirations, and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.