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Quality Assurance Specialist II

2 months ago


Mount Prospect, Illinois, United States Thermo Fisher Scientific Full time

At Thermo Fisher Scientific, you will engage in meaningful work, innovative thought processes, and a culture that prioritizes ethical practices, always keeping the customer at the forefront. The contributions we make are significant, from aiding in the discovery of cancer treatments to ensuring food safety and providing solutions for global health challenges. As a leading entity in the scientific community, we invest heavily in research and development, empowering our team members to reach their full potential within a rapidly expanding, global organization that values unique talents and passions.

Location/Division Specific Information:

Clinical Trials Division (CTD) collaborates with pharmaceutical and biotechnology clients worldwide to guarantee that patients receive the appropriate therapies in the correct dosages at the right times, embodying our principle that "There is a Patient Waiting."

Key Responsibilities:

  • Conduct thorough inspections and implement comprehensive quality control measures to enhance product quality and customer satisfaction.
  • Approve specifications and perform incoming inspections on pharmaceuticals and components.
  • Execute process inspections, sampling, and audits as necessary.
  • Ensure timely resolution of issues and the implementation of corrective actions.

Qualifications:

Education:

  • High school diploma or equivalent is mandatory.

Experience:

  • Minimum of 1 year of experience in a quality assurance or quality control role is required.
  • Preferred experience in a current Good Manufacturing Practices (cGMP) environment.

Skills and Abilities:

  • Proficient in Microsoft Office Suite (Outlook, Word, Excel) and knowledgeable about cGMP for pharmaceutical products.
  • Familiarity with Quality Systems, including Change Control, deviations, complaint management, and documentation management.
  • Strong analytical and problem-solving skills, along with basic math and interpersonal skills.

Physical Requirements / Work Environment:

  • Must be able to work in various clean room settings, including ambient, refrigerated, and freezer environments.
  • Ability to wear necessary personal protective equipment (PPE) such as filtering face masks and safety glasses.
  • Vision requirements include close, distance, color, peripheral, and depth perception.
  • Must pass a TSA background check.

Benefits:

We provide competitive compensation, an annual incentive plan, healthcare benefits, and a variety of employee perks. Thermo Fisher Scientific is committed to fostering an innovative and forward-thinking workplace, offering exceptional career development opportunities. Our company culture emphasizes integrity, intensity, involvement, and innovation.

Our mission is to empower our customers to create a healthier, cleaner, and safer world. We are united by a common set of values - Integrity, Intensity, Innovation, and Involvement - working collaboratively to advance research, tackle complex scientific challenges, drive technological advancements, and support patients in need.