Validation Quality Specialist
Company: Thermo Fisher Scientific
Posted on: February 13, 2019
Job Title: Validation Quality Specialist
Requisition ID: 86602BRWhen 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
Greenville, SCHow will you make an impact?
Provide Quality Assurance review/oversight for analytical and process validation activities related to GMP environment that relates to the review and generation of documents supporting regulatory, validation, and clients in which to maintain quality and improve efficiency.What will you do?
--- Provide quality oversight and compliance support related to analytical method development/validation and process development/validation in accordance with the corporate and site procedures and requirements.
--- Review protocol, data, and reports associated with development and validation activities related to GMP.
--- Review changes to validated state of system through the change control and participate in planning and implementing changes.
--- Leads, manages and/or participates in the investigation of non-conformances and follow-up corrective/preventative actions in compliance with quality procedures, policies and regulations.
--- For timely QA support to internal manufacturing and technical groups. Coordinates special projects within functional area.
--- For identifying potential compliance issues and leading opportunities for improvement to the product disposition system. Implements process changes to enhance compliance and improve manufacturing process.
--- Stakeholder in the development, implementation, and continued improvement of quality systems within the QA department.
--- Participate when required for QA Specialist batch record review.
--- Assist with Document Control functions as required.How will you get here?
--- BS - Life Sciences or equivalent experience.
--- 2+ years of experience in a GMP environment (QA, QC, manufacturing).
Knowledge, Skills, Abilities
--- Knowledge of FDA/EMA regulatory requirements applicable to drug product/substance pharmaceutical manufacturing. Ability to apply GMP regulations and other international guidelines to all aspects of the position.
--- Communicates with contractors and internal manufacturing/technical groups regarding compliance and quality issues (i.e., batch documentation, investigations, timelines and data related issues).At Thermo Fisher Scientific, each one of our 70,000 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, Greenville , Validation Quality Specialist, Other , Greenville, South Carolina
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