Supplier Auditor

Job Description

As a member of the Supplier Auditing team within the PSG Global Supplier Quality organization, the Supplier Auditor will be a key contributor to the global supplier audit management and supplier qualification processes at Thermo Fisher. The Supplier Auditor will also have experience in Pharmaceutical and/or Medical Device manufacturing or similar field, possessing technical capabilities, problem solving knowledge, and project management skills.

The Supplier Auditor will have the ability to work independently, collaborate, influence, and drive decisions at the right level. This position will provide an opportunity to develop expertise in supplier qualification and auditing as well as other developmental opportunities related to systems and processes for supplier quality management.

Essential Functions:

Work with the global manufacturing/services network acting as a liaison to ensure all Pharmaceutical Services Group (PSG) suppliers (material and service) continue to deliver quality products and services to the company.

Participate in the PSG Global Supplier Quality (GSQ) team, performing supplier audits, maintaining supplier audit reports and managing / negotiating CAPA responses.

Lead communication related to supplier audits with suppliers and impacted sites.

Maintain audit plan status, handling Global Supplier Quality Agreements, and communicating with suppliers where appropriate to achieve these tasks.

Plan, perform and oversee the auditing process which includes timely completion of audits and agreements in the appropriate electronic-Quality System (TrackWise).

Lead or participate in PPI projects and initiatives to develop and implement improvements in GSQ.

Responsible for reviewing cGMP documentation and may be responsible for authoring cGMP documentation, developing and delivering training for GSQ related topics.

Support PSG manufacturing network with supplier quality, auditing and change notification activities and liaison with respective functions such as, Legal, Procurement, Supplier Change Notification and Supplier Performance Monitoring.

Provide supplier quality management guidance / support to the PSG manufacturing network during Client / Authority inspection.

Education:

A minimum of a Bachelor’s Degree is required in Engineering, Science, or Business

Experience:

A minimum of 5-10 years of relevant experience in a GMP environment, in any of the following industries: Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements, is required.

Knowledge and understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.

Knowledge and use of Quality Compliance Systems (Trackwise, etc).

Experience in a matrix organization.

Experience with supplier auditing and supplier quality management

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies:

Knowledge of regulatory requirements and cGMPs, such as FDA, EU, ISO

Strong communication skills (verbal and written), including technical writing.

Appreciates and respects diversity, cultures, and norms.

Proficient in Microsoft Office Suite (Word, Excel, and PowerPoint).

Proven self-starter with strong time management skills and the ability to work within a team as well as independently.

Must be able to multi-task and respond to shifting priorities.

Ability to learn new software and tools quickly.

Ability to perform all qualifications and job responsibilities within a multi-site, global, remote team.

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

Disclaimer:

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.