Quality Assurance Specialist III - Batch Release
Company: Thermo Fisher Scientific Inc.
Posted on: June 8, 2021
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
Support systems and new product introduction as a technical
resource by providing assessment technical expertise, problem
solving, and strategies for internal and external problem
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?
Bachelor's degree in science or related field is required, with
four (4) years' experience in pharma environment preferred.
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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