Work ScheduleStandard (Mon-Fri)
Environmental ConditionsLaboratory Setting, Office
Job DescriptionThis is a Hybrid role based at our GMP Laboratory in Middleton, WI. We welcome applicants from all locations within the U.S. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.
- Must be legally authorized to work in the United States without sponsorship.
- Must be able to pass a comprehensive background check, which includes a drug screening.
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 You'll 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:• Bachelor's 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 regional regulations and applicable global pharmaceutical industry guidelines
• 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.
• Occasionally drives to site or client locations, occasionally travels within the United States.
• 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.
