QA Specialist

at  Thermo Fisher Scientific

JOB DESCRIPTION

When you’re part of Thermo Fisher Scientific, you’ll discover impactful work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

QUALITY ASSURANCE SPECIALIST PRE-APPROVAL

Are you passionate about ensuring the highest quality standards in clinical trial supplies? We are seeking a dedicated Quality Assurance Specialist to join our QA Pre-Approval team. The role requires an in-depth understanding of clinical trial supplies and the services that Fisher Clinical Services GmbH (FCS) is able to provide according to FCS quality standards and timelines.

EDUCATION

Bachelor’s degree in science or equivalent or GxP training or previous experience in the pharmaceutical industry, quality, medication handling or scientific role.

EXPERIENCE

Quality approach and strong proven understanding of GMP and Good Clinical Practices Quality Systems Regulations and international quality standards

KNOWLEDGE, SKILLS, ABILITIES

• High level of accuracy and efficiency
• Proven track record to perform tasks with attention to details
• Ability to understand various operational processes
• Excellent communication and organizational skills
• Ability to express detail in simple terminology, both written and verbal
• Command of English and German at professional level
  Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

• Review and quality approval of pre-executed batch documentation, overview documents, and print requests for clinical labels
• Close collaboration with project managers to ensure alignment with customer and regulatory requirements
• Adherence to Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) guidelines and Fisher Clinical Services Standard Operating Procedures (SOPs)
• Coordination and internal communication regarding the scheduling and completion of the documentation reviews and approvals
• Provide support to improve documentation right first time metrics
• Ensuring any deviations or quality issues are appropriately documented
• Inputting or analyzing data for quality metrics
• Advise Manager of quality issues and maintain accurate records for all work activities
• Participation in Practical Process Improvement or other projects