Thermo Fisher Scientific QA Specialist 2 in Florence, South Carolina

Job Description

QA Specialist 2

Requisition ID: 65738BR

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

Florence, SC

How will you make an impact?

This individual will need to be available to work different shifts and potentially weekends.

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 Thermo Fisher 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 regulatory and in a GMP compliant manner by reviewing batch records and performing appropriate investigations.

  • Provide Quality Assurance support to resolving raw material, in-process material, bulk and final product, environmental, and system issues.

  • Assist in writing and revising site SOPs or other procedures as required.

  • Administer, document and maintain the Thermo Fisher Quality Systems conformance to regulatory requirements and company policies where appropriate through effective utilization of Thermo Fisher’s Quality Systems and tools, as well as direct actions.

  • Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross functional partnerships.

  • Support Site Training in development, delivery and maintenance of Quality training programs (e.g., CAPA process, GMP, etc.).

  • Provide input to the development of personal performance goals and departmental objectives; collaborate with Management to establish and meet targets and timelines.

  • Participate in the design and implementation of department and cross-functional initiatives.

  • Maintain a state of inspection readiness.

  • Review/Approve Manufacturing Documents for cGMP Compliance. Review and approve Executed Batch Records as needed. Compile and verify all documents associated with the batch for intermediate release. Perform release of site intermediates.

  • Facilitate lot disposition activities and achieve lot disposition standard lead times; review and initiate disposition activities for bulk product; assist in preparation of site finished goods lot release documentation.

  • Provide Quality oversight of discrepancies and development of associated CAPAs.

  • Review technical/ investigation reports as appropriate; review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate

  • Gather metric information for use in continuous improvement of areas of responsibility.

  • 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 Quality Management Ensure Approval/Timely Delivery of Product to Customers (Raw Materials and Intermediates).

  • Perform other duties as required.

How will you get here?

Education

  • High School diploma or equivalent minimally required. Bachelor degree in Chemistry, Engineering, Life Sciences or related field preferred.

Experience

  • Preferably 5+ years of experience in pharmaceutical or bio manufacturing and at least 2 years in Quality Assurance.

  • With a high school diploma, 8-10 years of experience in pharmaceutical, biological manufacturing, or other regulated industry, with at least 0-3 years in Quality Assurance

  • With a Bachelor degree, 3-5 years of experience in pharmaceutical, biological manufacturing, or other regulated industry, with at least 0-3 in Quality Assurance

  • Quality Compliance experience preferred

  • GMP experience strongly preferred

  • Previous experience with identifying, writing, evaluating and closing CAPAs and experience with internal and external audit principles preferred.

Knowledge, Skills, Abilities

  • Strong technical writing skills preferred.

  • Strong written and verbal communication skills

  • Change control practices/strategies

  • Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles

  • Strong knowledge of GMP, SOPs and quality systems.

At Thermo Fisher Scientific, each one of our 65,000 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.

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.