Supply Chain Quality Assurance Inspector - 2nd Shift

Thermo Fisher Scientific•Breinigsville, PA

1d•Onsite

About The Position

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. How will you get here?

Requirements

High School Diploma OR GED Required
3+ years of experience in Pharmaceutical or of a related, regulated industry.
Familiar with Quality Systems (Change Control, deviations, complaint management, documentation management, among others).
Must be able to work in a refrigerated environment (35F to 46F) with provided protective wear.
Must be able to work in a freezer (-20F) environment with provided protective wear.
Must be able to work in potent compound suites with provided protective wear (PPE).
Good reasoning and problem-solving skills, basic math skills, good communication skills, basic computer skills.
Must be willing to work various shifts and overtime depending on business needs.
Must be able to work independently.
Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP environment.
Must not be allergic to penicillin or cephalosporin products.
Extensive standing and walking on packaging floor in order to monitor room activities.
Work schedule, Monday through Friday, 8 hours per day.
Additional overtime and weekend (Saturday or Sunday) work may be required.
This position requires standing, bending and lifting.
Exerting and lifting up to 25lbs of materials occasionally, and 10lbs of materials regularly.
The position is exposed to cold temperatures for more than one hour at a time.
The position is exposed to -20F temperatures for at least 15 minutes at a time.
The position will be exposed to atmospheric conditions could require special personal protection equipment.
Incumbent must meet applicable visual acuity/color blindness standards to perform visual inspections in a cGMP environment
Able to lift 40 lbs. without assistance
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed
Cold Room/Freezers -22degreesF/-6degrees C
Fluctuating Temps hot/cold
Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Warehouse
Will work with hazardous/toxic materials

Responsibilities

Applies Good Manufacturing Practices (cGMP) in all areas of responsibility.
Demonstrates and promotes the company vision.
Performs approval of specifications and incoming inspections on material (i.e. drug, components) 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.
Author’s, revises, and complies with all relevant SOP’s and Work Instructions and properly documents activities when necessary.
Resolve and assure that issues potentially affecting product quality/compliance are escalated to the attention of the Team Leader and/or Management.
Assures that issues are resolved in a timely manner and corrective actions are implemented accordingly.
Performs all activities in a safe and efficient manner.
Other duties may be assigned to meet business needs.