Clinical Packaging QA Inspector — 2nd Shift

ThermoFisher Scientific; Allentown (Lehigh County); On-site; USD 45,000 - 65,000; Full time

Job summary

Thermo Fisher Scientific is seeking an Operations, Clinical Quality Assurance Inspector to support packaging activities for clinical and commercial products. The role emphasizes adherence to cGMP, interaction with cross-functional teams, and strong communication to ensure quality throughout the packaging process.

Responsibilities include reviewing specifications, inspecting materials, and supporting continuous improvement initiatives while maintaining compliance with quality systems.

Qualifications

• Associates degree preferred.
• High School Diploma or equivalent required.
• At least 2 years of experience in Pharmaceutical or related regulated industry.
• Familiar with Quality Systems (Change Control, Deviations, Complaint Management, Documentation Management).
• Work in refrigerated environments (2° C to 8° C) and freezer environments (-20° C) with PPE.
• Willing to work various shifts and overtime as needed.
• Ability to read, understand, and follow GMP SOPs and Work Instructions.

Responsibilities

• Apply cGMP in all areas of responsibility.
• Demonstrates and promotes the company vision.
• Performs approval of specifications and Incoming Inspections on material and distribution shipments.
• Performs material and process inspections and samplings.
• Reviews and approves Packaging Electronic Production Orders.
• Participates in continuous improvement initiatives and assists with root-cause investigations.
• Documents activities in SOPs/Work Instructions and follows procedures.
• Escalates issues potentially affecting product quality/compliance to Team Leader/Management.
• Ensures timely resolution of issues and implements corrective actions.
• Performs all activities safely and efficiently.

Skills

Quality Systems familiarity

cGMP regulations knowledge

Good documentation practices

Attention to detail

Communication skills

Education

Associates degree preferred

High School Diploma or equivalent

Job description

Thermo Fisher Scientific is seeking an Operations, Clinical Quality Assurance Inspector to support packaging activities for clinical and commercial products. The role emphasizes adherence to cGMP, interaction with cross-functional teams, and strong communication to ensure quality throughout the packaging process.

Responsibilities include reviewing specifications, inspecting materials, and supporting continuous improvement initiatives while maintaining compliance with quality systems.