Quality Release Lab Manager

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Join Us as a Manager Lab Quality - Production Release Testing
The Manager Lab Quality oversees the Quality Control (QC) program for in process manufacturing laboratory operations. This role involves strategic planning and cross functional alignment including actively communicating with operations, engineering and quality assurance functions to obtain manufacturing and operational goals. This position is responsible for ensuring appropriate Quality Control resources and to support Lab Supervisor in scheduling to perform quality control functions. The manager provides structure for the content of QC reports and training, and continuous improvement of lab processes. They serve as an advisor for interpreting QC report content supplementing the Lab Supervisor, as needed.

What You'll Do:
• Oversee the implementation and continual improvement of the QC processes.
• Serve in a site leadership role through active participation in leadership team meetings.
• Hire, develop and mentor staff to expand organization's capability and ensure effective management of staff.
• Define and monitor performance metrics measuring lab quality. Advise staff on areas of improvement, QC focus areas and efficiency in the quality control process.
• Consult with laboratory management regarding priority of data and reports submitted to QC and assign work, accordingly, ensuring timely delivery of products to the customer.
• Oversee the effective training of staff within the QC department. Prepare written procedures and training material.
• May act as on-site subject matter expert for root cause analysis or CAPA.
• Provide key input and recommendation of data review or investigation process.
• Serve as lead for client discussions regarding project quality or investigations /nonconformance as they relate to studies

Education & Experience Requirements:

Associate’s degree in a scientific or technical field preferred (with strong relevant lab leadership experience) Focus* Technical degree in Manufacturing Technology, Applied Science, or Laboratory Technology.

HS diploma with significant (5+ years) manufacturing lab experience and 3+ years of leadership

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) or equivalent and relevant combination of education, training, & experience.
• 3+ 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:
• Excellent knowledge of SOPs to include GLP and GMP practices
• Excellent knowledge of analytical methodologies, instrumentation and method validation
• Excellent knowledge with laboratory systems and compliance strategies
• Working knowledge with computerized databases and data acquisition systems
• Strong verbal and written communication skills
• Strong attention to detail
• Strong program management skills
• Ability to deal with multiple and changing priorities
• Strong leadership and time management skills
• Ability to train and mentor staff

Working Conditions and Environment:
• Work is performed in an office environment with exposure to electrical office equipment.
• Frequently drives to site locations and frequently travels both domestic and international.

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. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthroughs.