Thermo Fisher Scientific Quality Specialist II in Cincinnati, Ohio

Job Description

Job Title: Quality Specialist II

Requisition ID: 80461BR

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Location/Division Specific Information

Cincinnati, OH Pharma Services Group, Oral Solid Dosage (OSD)

How will you make an impact?

Performs Annual Product Reviews (APR) and Product Quality Reviews (PQR) for product on the market and prepares reports for manufactured/packaged products per US GMP and European GMP requirements. Reviews and approves APR reports. Follows up on recommendations in APR reports to assure that they are implemented in a timely manner. Assures completed reports are sent to clients in a timely manner. Interacts with Clients regarding questions related to the content of the reports or trends noted. Must be able to collect data from various resources (Engineering, QC, QA, Process Pharmacists, manufacturing) around the company and assemble this into one report. Must be able to work with a variety of resource owners to collect and interpret data, and prepare reports. Manages and Maintains APR/PQR and Process Validation files.

What will you do?

  • Incumbent must have a working knowledge of GMPs and Thermo Fisher Scientific/Patheon quality systems.

  • A good understanding of manufacturing operations as well as quality operations and change control processes is required.

  • Able to read and interpret relevant regulations.

  • Familiarity with batch records and the ability to use or learn LIMS, TrackWise, SAP, and SAS/JMP/MiniTab is required.

  • Able to interpret raw data and recognize trends or issues to be addressed. Must be a self-starter and able to work independently

  • Able to influence others to address recommendations in the report.

  • Have excellent written communication skills.

How will you get here?

Education & Experience

Minimum of a BS degree in Chemistry, Pharmacy or a related science with relevant experience in pharmaceutical Manufacturing or Quality.

Minimum of two years’ experience in Quality Assurance, Quality Control and/or in a pharmaceutical Manufacturing (FDA regulated) industry.

Knowledge, Skills, Abilities

  • Able to communicate clearly with Clients regarding content of APR/PQR or our interpretation of the data.

  • Provide updates to recommendations as requested.

  • Familiar with Batch Records and LIMS formats to be able to perform QA review of these documents to support operations.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.