At Thermo Fisher Scientific, the business problem is to improve global health, cleanliness, and safety by ensuring compliance with established quality assurance processes and standards, and delivering groundbreaking innovations in laboratory, digital and decentralized clinical trial services.
Requirements
- Proven experience in conducting internal and external audits.
- Knowledge of quality assurance processes and global regulatory guidelines.
- Ability to identify and assess quality and compliance issues.
- Experience in technical document review and GxP activities.
- Strong problem-solving skills to determine root causes and develop solutions.
- Ability to successfully implement strategies and deliver quality services.
- Knowledge of laboratory, digital and decentralized clinical trial services.
Responsibilities
- Conduct complex internal and external audits to ensure compliance with established quality assurance processes and standards.
- Ensure adherence to global regulatory guidelines and client contractual obligations.
- Identify issues impacting quality and regulatory compliance.
- Support the determination of root causes of non-conformance and assist in developing strategies to address these issues.
- Perform technical document reviews and other GxP activities in support of project work or company processes.
- Provide completed audit reports to management.
- Plan and deliver billable quality services for clients and projects.
Other
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’).
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary and/or standing for typical working hours.
- Able to lift and move objects up to 25 pounds.
