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Quality Assurance Specialist

2 months ago

Allentown, Pennsylvania, United States Thermo Fisher Scientific Full time

About Thermo Fisher Scientific

We are a leading global biotechnology company that enables our customers to make the world healthier, cleaner, and safer. Our mission is to enable our customers to make a positive impact on a global scale.

Job Summary

We are seeking a Quality Assurance Specialist to support all Quality functions in relation to packaging activities of clinical product processed through primary and secondary packaging operations. The successful candidate will have experience with cGMP regulations and strong communication skills.

Key Responsibilities

  • Apply Good Manufacturing Practices (cGMP) in all areas of responsibility.
  • Demonstrate and promote the company vision.
  • Perform approval of specifications and Incoming Inspections on material (drug, components) and distribution shipments.
  • Perform 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 nonconforming issues.
  • Author, revise and follow all relevant SOP's/Work Instructions and accurately document activities as needed.
  • Resolve and assure that issues potentially affecting product quality/compliance are raised to the attention of the Team Leader and/or Management.
  • Assure that issues are resolved in a timely manner and corrective actions are implemented accordingly.
  • Perform all activities in a safe and efficient manner.

Requirements

  • 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, among others).
  • Ability to work independently.
  • Skills required; to read, understand, and follow the SOP's, Work Instructions and policies of a GMP environment.

Physical Requirements

  • 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 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.
  • Position is responsible for inspection of pharmaceutical products, components, and labels. Incumbent must meet applicable visual acuity/color blindness standards to perform visual inspections in a cGMP environment.

Benefits

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.