Job Opening: Analyst QC Analytical Technical Support Specialist
We are seeking two (2) Analyst QC Analytical Technical Support Specialists for our client company, located at QC Boudry - Celgene International. The duration of the contract is from July 1, 2024, until May 31, 2026. Candidates should possess professional proficiency in both French and English, along with excellent communication and project coordination skills.
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. You will provide support and training to End-Users in the QC laboratories, assist in investigations, and resolve issues. The Specialist will report directly to the Senior Manager of QC Analytical Tech Support.
Key Responsibilities
- Serve as the super user of laboratory computerized systems, executing master data management activities and new method setups in systems (e.g., Empower, Dissolution Workstation, and others as assigned).
- Execute verification protocols for custom calculations and perform audit trail reviews to ensure data integrity.
- Assist QC End Users with software-related issues and provide end-user training and on-the-job training for new employees.
- Update and review associated GMP documents and procedures while supporting change controls for QC software.
- Conduct risk assessments and oversee equipment lifecycle activities.
- Perform feasibility experimental work as needed and support the decommissioning of analytical equipment.
- Facilitate equipment troubleshooting for End Users and promote safe work practices.
- Report incidents to the Environmental Health and Safety department and participate in investigations to prevent future occurrences.
- Demonstrate Bristol Myers Squibb values and perform other tasks as assigned.
Qualifications & Experience
- Educational requirement: Federal Certificate of Capacity as Laboratory Technician or a BS degree in Life Science, Chemistry, or a relevant scientific discipline; or equivalent combination of education, training, and experience.
- Minimum of 2 years of relevant work experience, preferably in a regulated pharmaceutical environment.
- Scientific and practical knowledge of analytical techniques (e.g., chromatography techniques, dissolution, UV/VIS, and IR techniques).
- Previous experience with laboratory equipment qualification is preferable.
Required Competencies
- In-depth scientific knowledge of chromatography techniques (HPLC, UPLC, GC), dissolution, Karl Fischer, and spectroscopic techniques.
- Exceptional knowledge of LIMS and Empower applications.
- Advanced understanding of cGMP, ISO, FDA, MHRA requirements, and good documentation practices.
- Strong grasp of data integrity principles, including familiarity with audit trail review requirements.
- General computer literacy, especially in MS Office applications (Word, Excel, PowerPoint, Outlook).
- Effective verbal and technical writing skills, with experience in drafting GMP documents (procedures, protocols, plans, and reports).
- Proven analytical, problem-solving, and continuous improvement skills along with excellent time management and attention to detail.
- Ability to work independently while complying with regulations and physical requirements for prolonged standing, sitting, and other activities necessary for performing job duties.
- Fluency in English and professional proficiency in French, both written and verbal.
To apply, please apply online using the form below. Only applications matching the job profile will be considered.