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QC Engineer Scientist III

Company: Thermo Fisher Scientific Inc.
Location: Logan
Posted on: June 9, 2021

Job Description:

Job Description

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

Middletown, VA

How will you make an impact?

The Quality Control Scientist III operates from established and well-known procedures under general directions and minimum supervision. Decisions are made within prescribed operating and casualty procedures and guidelines. The Quality Control Scientist III encounters recurring work situations of high complexity, with frequent variations from the norm.

What will you do?

  • Manage QC testing of Bioburden to ANSI/AAMI/ISO 11737-1:2018

  • Manage QC Sterility to ANSI/AAMI/ISO 11137-2 VDmax

  • Perform and Manage Validations of test methods and/or equipment.

  • Manage QC lab related to in-process endotoxin and particulate testing.

  • Participate in endotoxin and particulate testing of product as required.

  • Participate in the Environmental Monitoring Program.

  • Participate in performance of in-process, finished product, and raw material testing of Single Use Technologies containers as needed.

  • Determine requirements of existing and future external testing.

  • Develop and qualify new internal QC testing requirements for products and processes as needed, following applicable regulatory requirements.

  • Manage & coordinate all external laboratory testing for Quality Control areas within the Logan site.

  • Work with other departments to establish best practices of testing and laboratory practices.

  • This position requires following cGMP (Current Good Manufacturing Practices) and working in a fast-paced team environment.

  • Maintain accurate records of test results.

  • Understand monograph testing such as USP, ISO and EudraLex.

  • Aspetic technique in a Biosfatey hood.

  • Order (oracle) and keep inventory of laboratory supplies.

  • Educate and train laboratory personnel.

  • Develop testing methods and create work instruction documents and forms.

  • Attain a proficiency with equipment in the QC laboratories and quickly gain proficiency with new equipment and procedures.

  • Use MS Office programs and other software programs as needed. (Word, Excel, Powerpoint, Outlook, Oracle, Master Control, Bluehill Instron software, Label vision)

  • Manage the execution of special projects as assigned by Quality management.

  • Assist in the analysis and trending of required data.

  • Work collaboratively with operations, engineering and quality personnel.

  • Actively participate in investigations related to customer complaints, Problem Notifications (PN), Non-conforming Material (NCMs), Unplanned Deviations (UD), etc

  • Actively participate in what could go wrong (WCGW) exercises as needed

  • May be required to perform other related duties as required and/or assigned

How will you get here?

Education/Experience

  • Bachelor degree (or higher) Degree in Biological Sciences

  • Eight or more years experience in biological / pharmaceutical laboratory applications

Knowledge, Skills, Abilities

  • Ability to work with quality engineering and process engineering personnel

  • Ability to accurately follow procedures

  • Participate in continuous improvement teams through PPI

  • Ability to work independently with little direct supervision

  • Experienced with MS Office applications / Excel Spreadsheets

  • Experienced with various computer systems / software

  • Experience working in cGMP environment

  • General knowledge of ISO 13485

  • Organization Skills

  • Attention to detail

  • Problem solving skills/Root Cause Analysis experience

  • Working knowledge of Good Documentation Practices (GDP)

  • Ability to identify risks/hazards related to quality and safety

Physical and Environmental Requirements:

  • Ability to work in a fast paced controlled cleanroom environment. (The Clean-room is controlled a greater than 30% humidity with a temperature between 60 and 70 F; Clean-room has some ambient noise)

  • Specific gowning is required including: gloves, hair and beard net and face cover, safety glasses with no makeup / jewelry or piercings.

  • Ability to use PPE (Personal Protective Equipment) and understand chemical hygiene including labels and SDS (Safety Data Sheets), common chemicals are disinfectant, solvents and IPA (Isopropyl Alcohol 70% and 99%).

  • Must have the ability to stand and move about including reaching, bending, stooping, grasping.

  • Must have the ability to frequently lift and manipulate up to 50 pounds unassisted.

Minimum Requirements/Qualifications:

Non-Negotiable Hiring Criteria:

  • Bachelor degree (or higher) Degree in Biological Sciences

  • Minimum 8 years' experience in related field

  • Problem solving skills/Root Cause Analysis experience

  • Demonstrate working knowledge of QMS tools

This position has not been approved for Relocation Assistance.

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

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.

Keywords: Thermo Fisher Scientific Inc., Logan , QC Engineer Scientist III, Other , Logan, Utah

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