Manufacturing Compliance Specialist
Company: Thermo Fisher Scientific Inc.
Posted on: August 5, 2022
- Technical Writer IJob DescriptionJob Title: Specialist I,
Manufacturing ComplianceWhen 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 InformationCambridge, MAHow will
you make an impact?The Manufacturing Compliance Specialist I
reports into the Viral Vector Services group at Thermo Fisher
Scientific and is based in the Cambridge, MA office. The Specialist
I uses knowledge of cGMP regulations and project management, to
ensure manufacturing readiness. The Specialist I will also support
documentation, investigations and improvement initiatives within
manufacturing operations.At Viral Vector Services (VVS) a division
of Thermo Fisher Scientific we deliver, from process development
through commercial supply, we offer the expertise and resources
necessary to help clients deliver innovative gene therapies. Placed
in the forefront of our leading and cutting edge Cell and Gene
Therapy business enabling clients to cure genetic, rare, and
otherwise untreatable diseases.What will you do?
- Works independently with minimal supervision and
- Partner with Quality for Deviation Triage and Ownership. (On
the floor DART support)
- As needed lead minor manufacturing investigations.
- As needed Support Dart Team
- Ownership of AA's, RAA's, CAPA's and or other quality records
- Support manufacturing corrective and preventative actions.
- Practices and promotes safe work habits and adheres to safety
procedures and guidelines.
- Applies manufacturing process knowledge and investigational
skills to identify and resolve manufacturing issues and drive
continuous improvement in process operations.
- Supports cross-functional continuous improvement teams, with
Engineering, Validation, Quality Assurance, Quality Control,
Facilities, and Manufacturing Science and Technology
- Works in coordination with others to meet group and
- Proactive identification and mitigation of risks.
- Identification of process changes and improvements
- Support daily huddle meetings if needed.How will you get
- High school diploma or GED equivalency.
- Bachelor's Degree preferred.
- Minimum of 0-2 years' experience in pharmaceuticals
manufacturing and/or quality.Experience
- Proven ability to motivate exempt and non-exempt employees and
demonstrated management skills, (i.e., business knowledge,
leadership, communication, ability to analyze technical issues,
conflict resolution). Thorough knowledge of cGMPs.
- Strong interpersonal and communications skills; written and
oral.Knowledge, Skills, Abilities
- Ability to function in a fast paced, dynamic environment with
multiple priorities simultaneously.
- Strong interpersonal and communication skills and the ability
to work effectively with a wide range of constituencies in a
- Ability to make decisions and work with minimal to moderate
- Able to provide effective written or verbal communication to
peers, senior associates, and area management within their
- Strong planning, organization and multitasking skills.
- Proven understanding of root cause analysis tools.
- Experience with Trackwise.At Thermo Fisher Scientific, each one
of our 75,000 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 safeApply today! 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.
Keywords: Thermo Fisher Scientific Inc., Cambridge , Manufacturing Compliance Specialist, Other , Cambridge, Massachusetts
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