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Thermo Fisher Scientific Quality Engineer in Remote / Field, North Carolina

Job Description

Position Summary:

The Quality Engineer is responsible for the implementation, management and sustainment of the Thermo Fisher Quality Management System with respect supplier quality to ensure conformity with US FDA, EU, ISO and other applicable quality and regulatory requirements as it applies to the manufacturing of raw material used in the production of pharmaceutical and biopharmaceutical products. While this position reports to the Sr. Manager, Supplier Quality, this position will also support the Director, Quality Management System with other Quality Management elements as required.

Key Responsibilities:

  • Ensure that the quality system is implemented at all levels within the organization to meet all applicable regulatory requirements, including but not limited to FDA EU, ISO.

  • Support the supplier audit program, including contract manufacturers and out-sourced packaging.

  • Support the development of labeling, product and process specifications in collaboration with Marketing, R&D, Product Development and other stakeholders.

  • Assist in the Review and approval of all specifications for suppliers and contract manufacturers, including finished, intermediate, raw material, labeling and process specifications. Maintains a document control process to ensure revision control.

  • Oversees supplier deviations, non-conformances and supplier corrective actions (SCARs) including review and approval of proposed actions. Ensures agreed upon containment, corrective and preventive actions are effectively implemented through established monitoring systems and the supplier audit program.

  • Manage the change notification process with all suppliers, contract manufacturers and PCC.

  • Responsible for the review of all batch records, incoming inspection, intermediate and finished product SOP’s for compliance to regulatory and Thermo Fisher requirements.

  • Represents Supplier Quality in external and internal audits.

  • Perform internal audits.

  • Other duties as assigned.

Minimum Requirements/Qualifications:

  • Minimum of 3 years’ experience within the Pharmaceutical or Pharmaceutical Industry supporting Regulated Products.

  • Minimum of 2 years of experience in a complex, biopharmaceutical manufacturing environment.

  • Excellent communication, collaboration and interpersonal skills with the ability to facilitate team interactions and to partner with and influence key stakeholders including Finance, R&D, Product Management, the Commercial Team and Customers.

  • Strong analytical ability including the ability to effectively use data in problem solving and to evaluate process changes and impacts.

  • Expert knowledge of quality standards and regulations (e.g., 21 CFR Part 210,211, ISO 9001) and Quality Management System design and oversight from a Pharmaceutical perspective.

  • Compliance with quality standards ((e.g., 21 CFR Part 210, 211, ISO, 9001)

  • Quality tools e.g. FMEA, Risk Analysis, RCA, Change Management

  • Global Systems e.g. TrackWise, AGILE, E1/SAP, LIMS

Non-Negotiable Hiring Criteria:

  • Bachelor’s degree from accredited college/university or equivalent experience with a preference for Science, Engineering, or specialty Biomedical Engineering

  • Strong written and verbal communication skills with effective strategies for interacting with a variety of audiences and situations

  • Proficient computer skills including email, word processing, spreadsheets, database and internet applications

  • requires 25%-50% travel

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility 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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