Senior QC Technician – GMP Packaging (2nd Shift)

Regulatory Jobs; Allentown (Lehigh County); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Healthcare

Bonus plan

Company benefits

Job summary

Thermo Fisher Scientific is seeking an Operations, Clinical Quality Assurance Inspector to support packaging activities of clinical products and some commercial packaging. The role requires strong communication skills, familiarity with cGMP, and collaboration with cross-functional teams at the Allentown site.

Responsibilities include ensuring compliance with quality systems, reviewing specifications, and performing inspections, with potential overtime and weekend work based on business needs.

Qualifications

• Associates degree preferred or High School Diploma required.
• At least 2 years of experience in Pharmaceutical or related regulated industry.
• Experience with Quality Systems (Change Control, Deviations, Complaint Management, Documentation Management, among others).
• Must be willing to work in refrigerated and freezer environments with provided PPE.
• Ability to work shifts and overtime depending on business needs.

Responsibilities

• Apply Good Manufacturing Practices (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.
• Review and approve Packaging Electronic Production Orders.
• Participates in continuous improvement initiatives and assists with root cause investigations for nonconforming issues.
• Documents activities accurately and follows SOPs/Work Instructions.
• Raises issues potentially affecting product quality to Team Leader/Management.
• Ensures timely resolution and implementation of corrective actions.
• Performs all activities in a safe and efficient manner.
• Other duties may be assigned to meet business needs.

Skills

Quality Systems

cGMP

SOPs

Documentation

Independent work

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 of clinical products and some commercial packaging. The role requires strong communication skills, familiarity with cGMP, and collaboration with cross-functional teams at the Allentown site.

Responsibilities include ensuring compliance with quality systems, reviewing specifications, and performing inspections, with potential overtime and weekend work based on business needs.