Weekend QA Team Lead for GMP & Clinical Packaging

ThermoFisher Scientific; Allentown (Lehigh County); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Healthcare

Annual bonus

Incentive plan

Job summary

Thermo Fisher Scientific in Allentown, PA is seeking a Team Leader, Quality Assurance to oversee the quality team for clinical packaging activities and ensure adherence to primary and secondary packaging processes.

You will work with cross-functional groups, drive continuous improvement, and mentor staff while upholding cGMP, FDA and ICH guidelines. Strong technical writing and leadership are essential.

Qualifications

• Bachelor’s degree (technical or life sciences) preferred.
• Experience with Quality Systems (Change Control, deviations, complaint management, documentation).
• Leadership experience in a regulated environment.

Responsibilities

• Oversee quality team and functions for clinical packaging activities.
• Ensure issues are resolved with timely corrective actions.
• Lead continuous improvement initiatives and document investigations.
• Interact with clients on quality issues and promote quality concepts.
• Ensure compliance with SOPs and regulatory requirements.

Skills

Leadership experience

Quality systems knowledge

Analytical/problem solving

Technical writing

Communication

Decision making

Planning and organizing

Education

Bachelor’s degree (technical or life sciences)

High school diploma or equivalent

Job description

Thermo Fisher Scientific in Allentown, PA is seeking a Team Leader, Quality Assurance to oversee the quality team for clinical packaging activities and ensure adherence to primary and secondary packaging processes.

You will work with cross-functional groups, drive continuous improvement, and mentor staff while upholding cGMP, FDA and ICH guidelines. Strong technical writing and leadership are essential.