Associate II, Quality Assurance

The Associate II, Quality Assurance is responsible for reviewing, assessing, and monitoring records, processes, and systems at critical control points. The role involves ensuring the effectiveness of corrective actions, stopping compromised manufacturing or distribution processes, and assisting or leading inspections and audits in a GMP environment such as blood banking, pharmaceutical, or medical devices.

Responsibilities

• Review, assess and monitor records, processes, and systems at the critical control points in the process.
• Monitor the implementation and effectiveness of corrective actions.
• Stop the manufacturing, testing and distribution of products and services if the process or product is compromised and take appropriate action.
• Assist and/or lead operating entities in preparing for, hosting, and closing out internal and external inspections and audits as necessary.
• Participate in and/or lead internal quality reviews of critical areas, operations, and processes.
• Participate in meetings for review of quality concerns.
• May represent department on projects, work groups, and process improvement teams.
• Identify and participate in process improvement and standardization activities and monitor change for effectiveness.

Requirements

• Bachelor’s degree required or equivalent combination of education and work experience.
• Minimum 3 years of related experience or equivalent combination of education and related experience required.
• Experience in QA, QC, or Quality Auditing preferably in a GMP environment such as blood banking, pharmaceutical, medical devices, or a hospital.
• Ability to work on a team.
• Good analytical and problem-solving skills.
• Demonstrated effective verbal and written skills.
• Strong analytical and problem-solving skills.
• Ability to effectively work with management, staff, and outside clients.
• Persuasive skill to achieve compliance with relevant procedures.
• Must display tact, diplomacy and professionalism in difficult situations.
• Must protect the confidentiality of sensitive information in the department.
• Regional travel will be required.

Skills

• Quality Assurance
• Quality Control
• Quality Auditing
• GMP Compliance
• Corrective Actions Management
• Analytical Skills
• Problem Solving
• Verbal Communication
• Written Communication
• Compliance Enforcement
• Confidentiality Management
• Teamwork
• Stakeholder Engagement
• Regional Travel
• Inspections and Audits

Languages

English