:
1. Sampling of raw material according to the guidelines and in a controlled environment.
2. Sound knowledge of equipment used for execution of test records (pH, conductivity, OSMO, etc.)
3. Assessment of analysis against predefined specification.
4. Effective execution of test records for customer requirements.
5. Peer review of analysis for completeness and correctness.
6. Assist QC Physiohemistry Team Leader in review/approval of test records, where relevant
7. Identify and report non-conformances and OOS/UR results directly to Team Leader, Supervisor and Manager.
8. Understanding of the Quality Control practices and principles across the full spectrum of site manufacturing services.
9. Support in the practical application of various risk assessment tools ( failure mode effect analysis, fishbone diagrams, hazard and operability studies) and ability to directly develop, participate, and advise others on the appropriate and efficient application of these processes.
10. Support in the practical application of the Quality System, Change Control, Deviations, CAPA, OOS and OOT, Document Management, related to the Quality Control Department.
11. Assist with site PPI projects.
12. Perform any other legitimate duties as directed by the Team Leader or/and Manager, QC Operations (or delegate).
Frequent Contacts:
Internal
13. QC Scientist and Operations staff
External
14. Various equipment vendors / maintenance contractors
Minimum Requirements / Qualifications:
Qualifications & Experience
15. Bachelor of Science (Biotechnology, Chemistry, or closely related degree). Background in analytical theory and technical competency with laboratory analysis. Knowledgeable with cGMP and various laboratory analyses, efficient sample workflows, in process controls, analytical testing and equipment maintenance/introduction.
16. Ability to effectively communicate in multiple modalities ( electronic, written, verbal, etc.), Good knowledge of Microsoft applications ( Excel, Word, Outlook, PowerPoint).
17. Ability to work on multiple projects simultaneously.
18. Strong team-working and collaborative skills. Previous experience in leadership and personnel management-desirable
Skills & Attributes
19. Adaptability: Ability to adapt to day to day business requirements.
20. Collaborating: Demonstrates the ability to work with all departments and colleagues of varied backgrounds.
21. Continuous Improvement: Demonstrates the ability to challenge the status quo to drive PPI.
22. Customer Focus: Demonstrates the ability to deliver on promises made to customers meet agreed due dates.
23. Initiating Action: Demonstrates the ability to work independently, and manage planned work. Ability to work on multiple projects or tasks simultaneously.
24. Quality Orientation: Ability to interpret and apply cGMP principles, strong attention to detail and accurate completion of test records. Strives for right first time in every task undertaken.
Other Job Requirements:
Deliver the best technical and scientific solutions to improve product value. Build a culture of engagement, accountability and a shared commitment to excellence. Abide by all EH&S policies and procedures, operate our business in a safe, focused, responsible, and ethical fashion. Work safely and only perform tasks if currently competent and/or authorised, participate in EH&S activities such as; GEMBA walks, inspections, and risk assessments.
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.