Compliance Specialist

At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life To enable our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond by developing solutions for some of the worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

Our manufacturing site in Ridgefield New Jersey is an integral part of our sterile fill-finish manufacturing network. The site bolstered by a dedicated team of Pharma Services colleagues enables our customers to deliver life-changing medicines to patients around the world. The Ridgefield site exemplifies our commitment to quality patient-safetyand innovation in the pharmaceutical industry making a significant impact on global health.

Discover Impactful Work:

The Compliance Specialist will be responsible for leading root cause analysis activities approving deviations reports and providing technical support to addition this role will be responsible for creation review and approval of CAPAs and Effectiveness Checks.

A day in the Life:

Lead and Author Investigations: Collaborate with Quality SMEs and Manufacturing to determine the scope of investigations lead investigation teams and ensure regulatory compliance.

Develop and Execute Investigation Strategy: Develop investigation strategies and complete investigations within required timelines utilizing Root Cause Analysis techniques.

Manage Deviations and CAPAs: Classify review and approve deviations; create and approve CAPAs to address root causes effectively.

Support and Present Investigations: Support investigations of minor non-conformances and present findings to the Management Review Board.

Trend Analysis and Recommendations: Trend deviation and CAPA reports making recommendations based on results.

Ensure Safety and Compliance: Promote a safe working environment support HSE policies complete required HSE training report accidents and incidents and ensure timely closure of HSE actions.

Keys to Success:

Education

• Bachelors Degree with 3 or more years experience completed deviations or in a QA Environment

Experience

• Working knowledge of cGMPs in pharmaceuticals/biological and aseptic manufacturing

• Preferred experience with Lean 5S and Gemba for CAPA

• Preferred experience with a deviation/CAPA enterprise systems

Knowledge Skills Abilities

• Excellent technical writing skills

• Leading Investigation Team

• Strong analytical and problem-solving skills

• Make sound judgement from data

• Strong communicator

• Works independently to ensure on-time investigation closure

• Working knowledge of Word Excel PowerPoint

Benefits:

We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!