Analyst QC Analytical Technical Support
Vor 3 Tagen
Analyst QC Analytical Technical Support (Office Job), Basel
Client:Gi Group SA
Location:Basel
Job Category:Other
Job Reference:01974276a0df
Job Views:5
Posted:21.01.2025
Expiry Date:07.03.2025
Job Description:For our client company, we are looking for a Analyst QC Analytical Technical Support Specialist Analytical Tech Support x2 (2 open positions).
Duration: 01.07.2024 until 31.05.2026
Contract: Temporary
Languages: French and English - Professional proficiency
Position Summary:
In this role, you will perform super user activities for the laboratory computerized systems, including Master Data Management, and associated GMP document updates. This position will act as a Super User providing support and training to End-Users of the QC laboratories as well as supporting investigations and resolution of issues. The Specialist will report to the Sr. Manager QC Analytical Tech Support.
Key Responsibilities:
- Super user of laboratory computerized systems.
- Perform master data management activities and new methods set up in computerized systems (e.g., Empower, Dissolution Workstation, other systems as assigned).
- Execute verification protocol for custom calculations.
- Perform audit trail reviews and assure adherence to data integrity principles.
- Assist QC End Users with software issues.
- Provide end user training and on-the-job training for new employees where required.
- Update and review associated GMP documents and procedures.
- Support change controls for QC software.
- Perform feasibility experimental work as needed.
- Support decommissioning of analytical equipment.
- Support End-User with equipment troubleshooting.
- Promote safe practices and behaviors.
- Report incidents to Environmental Health and Safety department, participate in investigations and identify preventive measures.
- Demonstrate Bristol Myers Squibb values.
- Perform other tasks as assigned.
Qualifications & Experience:
Education and Experience:
Federal Certificate of Capacity as Laboratory Technician or BS degree in Life Science, Chemistry, or relevant scientific discipline or equivalent combination of education, training, and experience.
Minimum 2 years relevant work experience required, preferably in a regulated pharmaceutical environment.
Scientific and practical knowledge of analytical techniques (e.g., chromatography techniques (HPLC, UPLC, GC), Dissolution, UV/VIS, and IR techniques).
Previous experience of laboratory equipment qualification is preferable.
Required Competencies: Knowledge, Skills, and Abilities:
- Good scientific knowledge of chromatography techniques (HPLC, UPLC, GC), dissolution, Karl Fischer, and spectroscopic techniques.
- Exceptional knowledge of LIMS and Empower applications.
- Advanced knowledge and interpretation of cGMP, ISO, FDA, MHRA and Pharmacopeia requirements, and good documentation practices.
- Advanced knowledge of Data Integrity principles, familiar with audit trail review requirements.
- General computer literacy including MS Office (Word, Excel, PowerPoint, Outlook).
- Effective verbal communication skills, ability to interact with different levels of the organization and departments.
- Effective technical writing skills, experience writing GMP documents (procedures, protocols, plans and reports).
- Proven analytical, problem-solving, and continuous improvement skills.
- Proven time management skills and a strong attention to detail.
- Ability to work independently and compliantly.
- Physical ability to perform tasks that may require prolonged standing, sitting, and other activities necessary to perform job duties.
- Fluent in English or French and professional command of the second language (written and verbal).
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