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Senior Quality Control Technician

2 months ago

Allentown, Pennsylvania, United States Thermo Fisher Scientific Full time

As a member of the Thermo Fisher Scientific team, you will engage in impactful work that contributes positively on a global scale. Our mission is to empower our customers to create a healthier, cleaner, and safer world. We equip our global teams with the necessary resources to achieve personal career aspirations while advancing scientific endeavors to tackle some of the most pressing challenges, such as environmental protection, food safety, and cancer research.

Role Overview:

This position is based at our Allentown, PA site, where we collaborate with pharmaceutical and biotech partners worldwide to ensure patients receive the appropriate therapies in the correct dosages at the right time. Our diverse range of services encompasses project management, packaging, distribution, transportation management, specialty logistics, clinical supply optimization, and bio-repository storage. With over 3000 dedicated employees across more than 15 countries, we understand the significance of our contributions.

Responsibilities:

The Clinical Quality Assurance Inspector will oversee all quality-related functions associated with the packaging of clinical products processed through primary and secondary packaging operations. This role also includes support for commercial packaging activities. Key responsibilities include:

  • Implementing Good Manufacturing Practices (cGMP) in all assigned areas.
  • Upholding and promoting the company’s vision.
  • Conducting approval of specifications and incoming inspections on materials and distribution shipments.
  • Performing inspections and sampling of materials and processes.
  • Reviewing and approving Packaging Electronic Production Orders.
  • Participating in continuous improvement initiatives and assisting with root cause analyses for nonconformities.
  • Authoring, revising, and adhering to all relevant SOPs/Work Instructions while accurately documenting activities as required.
  • Identifying and escalating issues that may impact product quality or compliance to the Team Leader and/or Management.
  • Ensuring timely resolution of issues and implementation of corrective actions.
  • Carrying out all tasks in a safe and efficient manner.
  • Performing additional duties as necessary to meet business requirements.

Qualifications:

Education:

  • Associate's degree preferred.
  • High School Diploma or equivalent required.

Experience:

  • Minimum of 2 years of experience in the pharmaceutical or a related regulated industry.

Knowledge, Skills, and Abilities:

  • At least 1 year of experience in the pharmaceutical or a related regulated field, along with a High School diploma.
  • Familiarity with Quality Systems, including Change Control, Deviations, Complaint Management, and Documentation Management.
  • Willingness to work in refrigerated (2° C to 8° C) and freezer environments (-20° C) with appropriate protective gear.
  • Flexibility to work various shifts and overtime as needed.
  • Ability to work independently and effectively.
  • Proficiency in reading, understanding, and following SOPs, Work Instructions, and GMP policies.

Physical Requirements:

  • Extensive standing and walking on the packaging floor to monitor activities.
  • Standard work schedule is Monday through Friday, 8 hours per day, with potential for overtime and weekend work.
  • Ability to stand, bend, and lift; occasionally lifting up to 25 lbs and regularly lifting up to 10 lbs.
  • Exposure to cold temperatures for extended periods.
  • Must meet visual acuity/color blindness standards for performing inspections in a cGMP environment.

Benefits:

We provide competitive compensation, an annual incentive plan, healthcare benefits, and a variety of employee perks. Thermo Fisher Scientific offers a dynamic, innovative work environment with excellent career development opportunities and a culture that emphasizes integrity, intensity, involvement, and innovation.