QC Scientist III

at  Thermo Fisher Scientific

Greenville, North Carolina, USA - 27833

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate18 Aug, 2021Not Specified18 May, 20216 year(s) or aboveConcentrations,Leadership Skills,Communication Skills,WritingNoNo
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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
Patheon, by Thermo Fisher Scientific, is transforming the way pharmaceuticals are made with a simplified, end-to-end supply chain for pharmaceutical and biopharmaceutical companies of all sizes.
Our growing Greenville, NC site is a large, multipurpose pharmaceutical manufacturing and packaging campus.
How will you make an impact?
You will perform transfer of analytical methods to the site for all new late phase and commercial products. In addition to method transfer, you will participate on all analytical activities for new product transfers to the site including coordinating and executing testing support for in-process, finished product release and stability testing of early development batches and validation batches until the product is transferred to the QC Commercial Labs.

What will you do?

  • Analytical method transfer activities of complex methods for late phase/commercial products.
  • Work directly with clients and internal departments in planning analytical activities for new product transfers.
  • Write, approve and execute method transfer/verification protocols and summaries in support of new projects.
  • Provide formulation DOE analytical support.
  • Evaluate and procure new analytical instrumentation and technologies in support of new product transfers.
  • Assist in resource planning of method transfer, in-process, product release, and early stability testing of new products.
  • Investigate Deviations and Out of Specification/Out of Trend instances and author reports.
  • Generate and edit analytical methods using Change Control.
  • Provide training of analytical staff to ensure accuracy, resulting in minimal deviations and errors.

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How will you get here?

  • Minimum BS/BA in Chemistry, Biochemistry, or related science field with 6 years Quality Assurance/Quality Control experience
  • Experience working on multifunctional project teams preferred.
  • Experience with Deviations and Out of Specification/Out of Trend investigations is preferred.

Knowledge, Skills, Abilities

  • Excellent organizational skills to be able to manage multiple tasks simultaneously, and the ability to appropriately prioritize tasks.
  • Strong knowledge of analytical method validation/transfer requirements.
  • Must be able to write clear, understandable documentation. Experience in writing method validation/transfer protocols and summaries preferred.
  • High level of verbal communication skills, and functional leadership skills.
  • Command of Quality System Regulations and cGMP.
  • Skilled at analyzing/interpreting data and summarizing results.
  • Excellent math skills including calculation of concentrations and dilutions.

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 safe

Responsibilities:

  • Analytical method transfer activities of complex methods for late phase/commercial products.
  • Work directly with clients and internal departments in planning analytical activities for new product transfers.
  • Write, approve and execute method transfer/verification protocols and summaries in support of new projects.
  • Provide formulation DOE analytical support.
  • Evaluate and procure new analytical instrumentation and technologies in support of new product transfers.
  • Assist in resource planning of method transfer, in-process, product release, and early stability testing of new products.
  • Investigate Deviations and Out of Specification/Out of Trend instances and author reports.
  • Generate and edit analytical methods using Change Control.
  • Provide training of analytical staff to ensure accuracy, resulting in minimal deviations and errors


REQUIREMENT SUMMARY

Min:6.0Max:11.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Proficient

1

Greenville, NC, USA