Thermo Fisher Scientific Change Control Specialist III in Franklin, Massachusetts
Job Title: Change Control Specialist III
Requisition ID: 154160BR
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 more than $24 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.
This role will report into the Pharma Services Group and can be based at any one of our Legacy Patheon sites globally (specific site options are listed in this job posting).
How will you make an impact?
As a member of the Systems and Processes (S&P) team within the Global Supplier Quality organization, the Change Control Specialist III will be a key contributor to the global supplier change notification process at Thermo Fisher. The Change Control Coordinator will be responsible for managing global coordination of multi-site supplier-initiated change notifications. The Change Control Specialist III will also have experience in Pharmaceutical / Medical Device manufacturing or similar field, possessing technical capabilities, problem solving knowledge, and project management skills.
The ideal candidate will have the ability to work independently, collaborate, influence, and drive decisions at the right level. This position will provide an opportunity to develop supplier change management subject matter expertise as well as other developmental opportunities related to systems and processes for supplier management.
What will you do?
Works across the global manufacturing network to triage all Pharmaceutical Services Group (PSG) impacted supplier-initiated changes, registering each change within the appropriate Supplier Change Notification system.
Identifies which PSG sites are potentially impacted for each supplier-initiated change through the use of the PSG Approved GxP Supplier List.
Collaborates with external suppliers, PSG sites, and functional global groups involved in the supplier change management process (Procurement, Site Quality, etc.) to obtain missing change information or report outstanding or overdue change control actions.
Responsible for supporting ongoing administration of the Supplier Change Notification system, including, but not limited to, updates to applicable procedures and work instructions related to the Supplier Change Notification process and procedures.
Collaborate with team members in order to continuously look for opportunities to improve processes.
Support ongoing validation testing activities related to the implementation and maintenance of S&P owned and managed systems.
How will you get here?
A minimum of a Bachelor's Degree is required in Engineering, Science, or Business
A minimum of 5 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 Change Control.
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills, Abilities:
Must understand worldwide regulatory requirements and cGMPs.
Knowledge of cGMPs and technical writing.
Good oral and written communication skills, i.e. effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills.
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.
Must be willing to learn how to (and then excel at) performing tester validation activities related to system implementation & upgrades.
Ability to learn new software and tools quickly.
Ability to perform all qualifications and job responsibilities with a multi-site, global, remote team.
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.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 Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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