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

Pharmaceutical Services Group / Quality Complaints .

How will you make an impact?

Provides technical leadership and Quality oversight in association with specific aspects of complaint investigations to ensure compliance with regulations that govern pharmaceuticals. Ensures the Company can operate without regulatory actions that impede product quality, cause product stoppages or reduce customer satisfaction.

What will you do?

• Investigates and authors complaint investigation reports to ensure adequate controls in relation to the level of product quality, safety and business risks.

• Processes and projects of moderate complexity, perform compliance assessments, make decisions regarding regulatory requirements, write new procedures and ensure adherence to current regulations.

• Conducts complaint investigation activities, including but not limited to conducting root cause analysis and takes appropriate actions during quality system management to ensure adequate controls in relation to the level of product quality, safety and business risks.

• Acts as a technical resource for support of complaint investigations by proactively interpreting regulatory and compliance requirements, establishing and maintaining systems.

• Serves as liaison for internal and external customers for complaint investigation activities.

• Independently solves moderate to complex problems and serves as a complaints expert..

How will you get here?

Education

Bachelor’s degree in a scientific or related field is required

Experience

Minimum of four (4) years of experience in a progressive role in the pharmaceutical industry with experience in conducting investigations, preferred.

Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills, Abilities

• Works on issues of moderate to high complexity related to compliance and quality complaints within the manufacturing areas – oral solid & sterile.

• Makes decisions while taking into account level of risks in regards to compliance and product quality.

• Outstanding attention to detail and organizational skills.

• Self-starter, mature, independent and dependable.

• Ability to work in a fast paced environment, able to multi-task and results-oriented.

• Demonstrates ability to maintain a high degree of confidentiality.

• Effective time management and prioritization skills.

• Requires discretion and independent judgment.

• Excellent interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters.

• Highly effective verbal and written communication skills.

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 safer.