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Thermo Fisher Scientific Manufacturing Compliance Specialist II in Lexington, Massachusetts

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.

What will you do?

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.

How will you make an impact?

The Manufacturing Compliance II will act as a lead investigator to conduct deviations in support of all phases of bulk drug substance and drug product manufacturing for clinical and commercial products. The Manufacturing Compliance member is essential to ensure GMPs are being met and facilitating investigations through the site’s Quality Systems using expertise of manufacturing unit operations / processes, compliance, and root cause analysis. This role will interface closely with other cross-functional groups such as, Manufacturing, Engineering, MS&T, Validation, Quality Control, and Quality Assurance.

What will you do?

  • Lead thorough deviations through the Quality System as a Lead Investigator. Drive investigations through the Quality System within established timelines.

  • Use knowledge of processes / unit operations to address manufacturing compliance events and drive continuous improvements.

  • Author strong technical impact assessments / compliance Deviation Reports.

  • Facilitate root cause analysis through cross-functional collaboration.

  • Works cooperatively with others to meet group and organizational goals.

  • Proactively provides investigation status updates to stakeholders.

  • Lead / facilitate discussions in a constructive and positive manner.

  • Define, own, and support creation of corrective and preventive action (CAPA) plans.

  • May support external audits performed by regulatory/inspection agencies or clients and audit/inspection readiness activities.

  • Participate in client and planning meetings as requested. Including but not limited to presentation and document preparation.

How will you get here?

Education:

BS/MS in Engineering or related science discipline and 3-5 years of experience in a cGMP environment.

Experience:

Experience with single use disposable systems and technologies and GMP know how is beneficial, in addition to experience in cell or gene therapy.

Knowledge, Skills, Abilities:

  • Skilled in use of Microsoft Outlook, PowerPoint, Word, Excel and GMP system programs and spreadsheets is mandatory, as is a capacity to follow written procedures, and the ability to read, write, speak, understand and to be understood in English.

  • This position requires the ability to work in a fast-paced team environment to meet goals and timelines and as such requires appropriate behavioral characteristics to be effective and successful.

  • Individual must be self-motivated, have excellent quality and organization skills and be detail oriented.

  • Strong planning, organization and multitasking skills.

  • Strong Project Management skills.

  • Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.

  • Ability to make decisions and work with minimal to moderate supervision.

  • Able to provide effective written or verbal communication to peers, senior associates, and area management within their operational groups.

  • Solid understanding of regulatory requirements.

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 80,000 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.

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