QA Team Lead – GMP & Clinical Packaging (Weekend)

Regulatory Jobs

Allentown (Lehigh County)

On-site

USD 90,000 - 120,000

Full time

5 days ago

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Job summary

Thermo Fisher Scientific in Allentown, PA is seeking a Team Leader, Quality Assurance to oversee the quality team in clinical packaging operations, coordinating with cross-functional groups to ensure adherence to GMP and quality systems. This role emphasizes leadership, problem solving, and effective communication, with a weekend schedule (Friday–Sunday) and possible overtime to transition during shifts.

A Bachelor’s degree and experience in a regulated industry are required, along with strong

Qualifications

Bachelor’s degree with technical or life sciences preferred.
Minimum 3 years with BS or 5 years in pharma/regulatory industry.
Experience leading teams and applying quality systems.
Strong knowledge of cGMP, FDA regulations, and ICH guidelines.

Responsibilities

Lead and develop the QA team, ensuring compliance with quality systems.
Review operations related to quality and communicate with cross functional groups.
Ensure timely resolution of quality issues and implement corrective actions.
Participate in continuous improvement initiatives.
Interact with clients on quality issues and document activities in SOPs and records.
Escalate issues potentially affecting product quality to management.