Associate Manager, Quality Assurance
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job Description
Join Us as an Associate Manager Quality Assurance - Make an Impact at the Forefront of Innovation
The Associate Manager Quality Assurance has responsibility for a QA team implementing elements of the quality management system. The role involves ensuring internal and/or client processes systems and/or projects are compliant and inspection ready. The Clinical Quality Assurance Supervisor manages and develops staff and ensures delivery of quality solutions in a collaborative cross-functional environment.
What Youll Do:
Manage the day-to-day operations of a QA team and provide oversight development and performance management to staff to meet performance objectives
Assess with supervisors priority of projects and monitor work assignments ensuring adequate resourcing to meet internal and client timelines and provide quality deliverables
Assist senior management in the evaluation of QA programs to help maintain regulatory compliance and efficiency of QA audits
Evaluate issues and trends reported by QA staff and determine appropriate departmental interpretation. Identify issues that may require follow-up or improvement. Communicate findings to staff and senior management
Participate in client and regulatory inspections in order to provide information regarding the QA program and facilitate responses
Education & Experience Requirements:
Bachelors degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 0 to 5 years).
1 year of leadership responsibility
In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.
Knowledge Skills Abilities:
Solid leadership and time management skills
Knowledge of appropriate regulations and applicable global pharmaceutical industry guidelines
Knowlege of Nonconformance Investigations Root Cause Analysis and CAPA.
For Lab QA Management knowledge of analytical methodologies instrumentation and method validation required
Good verbal and written communication skills
Demonstrated proficiency with regulations and guideline interpretation proper documentation and QA departmental policies and procedures
Detail oriented with ability to deal with multiple and changing priorities
Working Conditions and Environment:
Work is performed in an office and/or a laboratory and/or a clinical environment with exposure to electrical equipment.
Exposure to biological fluids with potential exposure to infectious organisms. Rare exposure to skin and lung irritants radiation toxic materials and hazardous waste.
Personal protective equipment required such as protective eyewear garments and gloves.
Exposure to fluctuating and/or extreme temperatures on rare occasions.
Why Join Us
When you join Thermo Fisher Scientific you become part of a global team that values passion innovation and a commitment to scientific excellence. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.
Apply today to help us deliver tomorrows breakthroughs.
Required Experience:
Manager
Employment Type : Full-Time
Experience: years
Vacancy: 1