Lead QC Technician

About the role

As part of the Thermo Fisher Scientific team in Allentown, PA, you will support Quality functions for clinical and commercial packaging activities. The position contributes to the company’s mission of enabling customers to make the world healthier, cleaner, and safer, and works within a global network that provides project management, packaging, distribution, transportation management, specialty logistics, and clinical supply optimization.

Responsibilities

• Support all Quality functions related to primary and secondary packaging of clinical products and commercial packaging activities.
• Apply Good Manufacturing Practices (cGMP) in all areas of responsibility.
• Approve specifications and perform incoming inspections on materials (drug, components) and distribution shipments.
• Conduct material and process inspections and samplings.
• Review and approve Packaging Electronic Production Orders.
• Participate in continuous‑improvement initiatives and assist with root‑cause investigations for non‑conforming issues.
• Author, revise, and follow all relevant SOPs/Work Instructions; accurately document activities.
• Identify and raise product‑quality or compliance issues to the Team Leader or Management, ensuring timely resolution and implementation of corrective actions.
• Perform all activities safely and efficiently.
• Other duties as assigned to meet business needs.

Requirements

• High School Diploma or equivalent required; Associate’s degree preferred.
• At least 2 years of experience in the pharmaceutical or a related regulated industry.
• Familiarity with Quality Systems such as Change Control, Deviations, Complaint Management, and Documentation Management.
• Ability to work in refrigerated (2 °C – 8 °C) and freezer (‑20 °C) environments with provided protective wear.
• Willingness to work various shifts, overtime, and occasional weekend work based on business needs.
• Ability to work independently and follow SOPs, Work Instructions, and GMP policies.

Skills

• Strong verbal and written communication skills.
• Problem‑solving ability and capacity to ensure adherence to established quality systems.
• Ability to read, understand, and apply SOPs and work instructions in a GMP environment.

Physical requirements

• Extensive standing and walking on the packaging floor to monitor activities.
• Occasional lifting of up to 25 lb and regular lifting of up to 10 lb.
• Exposure to cold temperatures for more than one hour at a time; exposure to 20 °F for at least 15 minutes.
• Use of personal protective equipment (safety glasses, gowning, gloves, lab coat, ear plugs, etc.).
• Must meet visual acuity and color‑blindness standards for pharmaceutical product inspection.

Schedule

Standard Monday – Friday, 2nd shift: 3:15 pm – 11:15 pm (8 hours). Overtime and occasional weekend (Saturday or Sunday) work may be required.

Benefits

• Competitive remuneration with an annual incentive plan bonus scheme.
• Healthcare coverage and a range of employee benefits.
• Opportunities for career development within an innovative, forward‑thinking organization.
• Company culture that emphasizes integrity, intensity, involvement, and innovation.