Analyst QC Analytical Technical Support / Analyst QC Analytical Technical Support

Job Opportunity: Analyst QC Analytical Technical Support Specialist

We are seeking two qualified candidates for the role of Analyst QC Analytical Technical Support Specialist at our client company. This position is available on a temporary contract from July 1, 2024, until May 31, 2026. This role is based in QC Boudry - Celgene International, where proficiency in both French and English is essential.

Position Summary

The Analyst QC Analytical Technical Support Specialist will perform super user activities for laboratory computerized systems, including Master Data Management and associated GMP document updates. As a Super User, you will provide support and training to end-users in the QC laboratories while assisting with investigations and issue resolution. You will report to the Sr. Manager of QC Analytical Tech Support.

Key Responsibilities

• Super user of laboratory computerized systems:
• Manage master data activities and set up new methods in computerized systems (e.g., Empower, Dissolution Workstation, and other assigned systems).
• Execute verification protocols for custom calculations.
• Perform audit trail reviews to ensure adherence to data integrity principles.
• Assist QC end users with software issues.
• Provide training to end users and on-the-job training for new employees as required.
• Update and review associated GMP documents and procedures.
• Support change controls for QC software.
• Assist in conducting risk assessments.
• Equipment lifecycle activities:
• Perform feasibility experimental work as needed.
• Support the decommissioning of analytical equipment.
• Assist end-users with equipment troubleshooting.
• Promote safe practices and behaviors.
• Report incidents immediately to the Environmental Health and Safety department, participate in investigations, and identify measures to prevent similar accidents in the future.
• Demonstrate Bristol Myers Squibb values.
• Perform other tasks as assigned.

Qualifications & Experience

• Education: 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.
• Experience: Minimum of 2 years of relevant work experience, preferably in a regulated pharmaceutical environment.
• Scientific knowledge of analytical techniques including chromatography techniques (HPLC, UPLC, GC), dissolution, UV/VIS, and IR techniques.
• Previous experience with laboratory equipment qualification is preferable.

Required Competencies: Knowledge, Skills, and Abilities

• Good scientific knowledge of chromatography techniques, dissolution, Karl Fischer, and spectroscopic techniques.
• Exceptional knowledge of LIMS and Empower applications.
• Advanced understanding of cGMP, ISO, FDA, MHRA, and Pharmacopeia requirements, as well as good documentation practices.
• Proficient in Data Integrity principles and familiar with audit trail review requirements.
• General computer literacy, including MS Office (Word, Excel, PowerPoint, Outlook).
• Effective verbal communication skills, with the ability to interact with various organizational levels.
• Strong technical writing skills, with experience in writing GMP documents, including procedures, protocols, plans, and reports.
• Proven analytical, problem-solving, and continuous improvement skills.
• Effective time management skills with a strong attention to detail.
• Ability to work independently and compliantly.
• Physical capability to perform tasks that may require prolonged standing, sitting, and other activities necessary for job duties.
• Fluency in English and professional command of French (written and verbal).

Apply online using the form below. Only applications matching the job profile will be considered.

For more information, please contact Show e-mail.