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Quality Assurance Specialist III - Batch Release

Company: Thermo Fisher Scientific Inc.
Location: Greenville
Posted on: June 8, 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

Pharmaceutical Services Group

How will you make an impact?

Responsible for the batch record review and release activities while being a subject matter expert for the team. The team provides direct quality support to ensure compliance with regulations that govern pharmaceuticals. You'll be accountable for internal and external interactions that enhance the QA reputation and that set the example for others to follow. You'll be responsible for driving strong Customer Satisfaction by ensuring compliance.

What will you do?

  • You'll perform record review, final product release functions, and quality oversight at the Greenville Site while being a subject matter expert for the team.

  • Ensure quality of methods, processes, materials and products by providing coordination and review of group operations, staff training, and the assessment/improvement of systems and processes.

  • Support systems and new product introduction as a technical resource by providing assessment technical expertise, problem solving, and strategies for internal and external problem prevention.

  • Assure compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements, establishing and maintaining systems.

  • Conduct risk assessments and take appropriate actions during quality system management and oversight activities (e.g. during review/approval) to ensure adequate controls in relation to the level of product quality, safety and business risks.

  • Maintain current knowledge of emerging trends and technologies. Serves as a technical resource including audit support.

  • Foster an environment of growth by providing training and/or opportunities for career development within department.

How will you get here?

Education

Bachelor's degree in science or related field is required, with four (4) years' experience in pharma environment preferred.

Experience

Minimum of three (3) years of experience in a progressive role in QA or QC within pharmaceutical industry or GMP environment.

Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills, Abilities

  • Knowledge of Batch Record Review Process, preferred.

  • Makes decisions while taking into account level of risks in regards to compliance and product quality.

  • Outstanding attention to detail and organizational skills.

  • Self-starter, mature, independent and dependable.

  • Able to plan and prioritize work to meet commitments aligned with organizational goals.

  • Requires discretion and independent judgment.

  • Promotes a customer-centered approach and is able to maintain an effective customer relationships

  • Highly effective verbal and written communication skills.

  • Computer literate; TrackWise and SAP, preferred

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

Keywords: Thermo Fisher Scientific Inc., Greenville , Quality Assurance Specialist III - Batch Release, Other , Greenville, North Carolina

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