Thermo Fisher Scientific Manufacturing Compliance Specialist II in Cambridge, Massachusetts
Job Title: Specialist II, Manufacturing Compliance
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.
Location/Division Specific Information
Cambridge, MA Drug Substance
How will you make an impact?
The Manufacturing Compliance Specialist II reports into the Viral Vector Services group at Thermo Fisher Scientific and is based in the Cambridge, MA office. The Specialist II uses expert knowledge of cGMP regulations and project management teams to ensure manufacturing readiness. The Specialist II will also support documentation, investigations and improvement initiatives within the 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?
Support manufacturing at obtaining required documentations for Major deviations (Record Scanning).
Works independently with minimal supervision and direction.
Partner with Quality for Deviation Generation. (On the floor support)
Lead minor manufacturing investigations.
Perform operator Interviews.
Support manufacturing corrective and preventative actions.
Practices and promotes safe work habits and adheres to safety procedures and guidelines.
Utilizes manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues and drive continuous improvement in process operations.
Builds cross-functional relationships and enhances relationships with team members.
Works cooperatively with others to meet group and organizational goals.
Proactive identification and mitigation of risks.
Identification of process changes and improvements.
Support daily huddle meetings if needed.
How will you get here?
High school diploma or GED equivalency.
Bachelor’s Degree preferred.
Minimum of 1-3 years’ experience in pharmaceuticals manufacturing and/or quality.
Demonstrated 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 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.
Strong planning, organization and multitasking skills.
Solid 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 safe
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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