Thermo Fisher Scientific Job - 30532016 | CareerArc
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Company: Thermo Fisher Scientific
Location: Florence, SC
Career Level: Associate
Industries: Healthcare, Pharmaceutical, Biotech

Description

Job Description

Job Title: Staff QA Analyst

When you join us at Thermo Fisher Scientific, you'll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location/Division Specific Information
Florence, SC – API Manufacturing

How will you make an impact?
Under general supervision, provide comprehensive technical support and quality assurance oversight to meet good business practices and the requirements of applicable regulatory agencies, supporting one of the following areas: manufacturing, testing, disposition, quality systems and distribution of Bulk drug substance.

What will you do?
• Apply technical knowledge to address a broad range of issues to ensure adherence to and compliance with established policies and procedures, as well as requirements of applicable Regulatory Agencies by working collaboratively with one or more of the following areas: manufacturing, testing, batch disposition, quality systems (discrepancy/investigation, supplier quality, CAPA), qualification-validation, and distribution of bulk drug substance.
• Provide support in the monitoring and analyzing of business process performance measures and notify management of potential quality or regulatory issues that may affect product quality or regulatory compliance. Ensure that the products are manufactured in compliance with the regulatory and in a GMP compliant manner by reviewing batch records and performing appropriate investigations.
• Sponsor/perform quality investigations of significant manufacturing deviations, GMP issues, system issues and non-conforming materials. Provide Quality Assurance support to resolving raw material, in-process material, bulk and final product, environmental, and system issues.
• Support Site Training in development, delivery and maintenance of Quality training programs (e.g., CAPA process, GMP, etc.).
• Perform technical and compliance review of assay history records for accuracy and completeness; summarize QC test results and annual product review report; provide input for the resolution of Out of Specification (OOS), complaints, discrepancies and CAPAs.
• Prepare, review, and approve lot for disposition; ensure Discrepancies and Change Controls are assessed and closed; ensure batch hold events are assessed and closed; communicate lot disposition pending issues to site Management Ensure Approval/Timely Delivery of Product to Customers (Raw Materials and Intermediates).

How will you get here?
Education
• BS - Chemistry, Engineering Life Sciences – required.
Experience
• 5+ years experience in Quality Assurance with 10+ years in pharmaceutical or bio manufacturing – required.
Knowledge, Skills, Abilities
• Previous experience with identifying, writing evaluating and closing CAPAs and experience with internal and external audit principals preferred.

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.



If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.

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.


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