Quality Assurance Inspector 3rd shift

Thermo Fisher Scientific•Allentown, PA

28d

About The Position

The Operations, Clinical Quality Assurance Inspector supports Quality functions related to packaging clinical products processed through primary and secondary packaging operations, as well as commercial packaging activities. The role works with management, the quality team, and cross-functional groups to ensure established quality systems are followed and product quality and compliance requirements are met. It requires problem-solving ability, effective verbal and written communication, and experience with cGMP regulations. The inspector performs material and process inspections and sampling, approves specifications and incoming inspections for materials and distribution shipments, and reviews and approves Packaging Electronic Production Orders. The role also supports continuous improvement and root-cause investigations, authors and revises relevant procedures, documents work accurately, and escalates and helps resolve issues that could affect product quality or compliance. The position works on third shift, scheduled Sunday at 11 p.m. through Friday morning at 7 a.m. Work involves extensive standing and walking on the packaging floor, bending and lifting, and exposure to refrigerated and freezer environments. Appropriate protective wear and other PPE are provided or required. The position includes visual inspection of pharmaceutical products, components, and labels and requires meeting applicable visual acuity and color-vision standards.

Requirements

High school diploma or equivalent required.
At least 1 year of experience in pharmaceutical or a related regulated industry; the posting also states at least 2 years of experience in pharmaceutical or a related regulated industry.
Familiarity with quality systems, including change control, deviations, complaint management, and documentation management.
Experience with cGMP regulations and ability to read, understand, and follow SOPs, work instructions, and policies in a GMP environment.
Ability to work independently.
Strong verbal and written communication and problem-solving skills.
Willingness to work various shifts and overtime depending on business needs.
Ability to meet applicable visual acuity and color-blindness standards for visual inspection.
Ability to stand, walk, bend, and lift; lift up to 25 pounds occasionally and 10 pounds regularly.
Ability to work in refrigerated and freezer environments and wear provided protective equipment.

Nice To Haves

Associate degree preferred.

Responsibilities

Apply cGMP requirements in all areas of responsibility.
Perform approval of specifications and incoming inspections on materials, including drugs and components, and distribution shipments.
Perform material and process inspections and sampling.
Review and approve Packaging Electronic Production Orders.
Participate in continuous improvement initiatives and assist with root-cause investigations for nonconforming issues.
Author and revise relevant SOPs and work instructions, follow them, and accurately document activities.
Raise issues that could affect product quality or compliance to the Team Leader and/or management.
Ensure issues are resolved in a timely manner and corrective actions are implemented.
Perform all activities safely and efficiently.
Inspect pharmaceutical products, components, and labels.
Carry out other duties as assigned to meet business needs.