QC Analytical Technical Support Analyst / QC Analytical Technical Support Analystess

Job Opportunity: Analyst QC Analytical Technical Support Specialist

We are seeking two qualified individuals for the position of Analyst QC Analytical Technical Support Specialist for our client company. This role is a temporary contract from July 1, 2024, to May 31, 2026, based at the QC Boudry - Celgene International site.

Position Summary

In this role, you will perform super user activities for laboratory computerized systems, including Master Data Management and associated GMP document updates. You will provide support and training to end-users of the QC laboratories, as well as assist in investigations and issue resolution. This position reports to the Sr. Manager QC Analytical Tech Support.

Key Responsibilities

• Act as a Super User for laboratory computerized systems:
• Perform master data management activities and set up new methods in computerized systems (e.g., Empower, Dissolution Workstation, and others as assigned).
• Execute verification protocols for custom calculations.
• Conduct audit trail reviews ensuring adherence to data integrity principles.
• Assist QC End Users with software issues.
• Provide end-user training 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 with risk assessments.
• Oversee 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 report incidents to the Environmental Health and Safety department, participating in investigations and implementing preventive measures.
• Embody Bristol Myers Squibb values.
• Perform other tasks as assigned.

Qualifications & Experience

• Education: Federal Certificate of Capacity as Laboratory Technician, BS degree in Life Science, Chemistry, or a relevant scientific discipline; or an equivalent combination of education, training, and experience.
• Minimum 2 years of relevant work experience is required, preferably in a regulated pharmaceutical environment.
• Scientific and practical knowledge of analytical techniques including chromatography (HPLC, UPLC, GC), dissolution, UV/VIS, and IR techniques.
• Previous experience with laboratory equipment qualification is preferable.

Required Competencies

• Strong scientific knowledge of chromatography techniques, dissolution, Karl Fischer, and spectroscopic techniques.
• Exceptional knowledge of LIMS and Empower applications.
• Advanced knowledge of cGMP, ISO, FDA, MHRA, and Pharmacopeia requirements, as well as good documentation practices.
• In-depth understanding of Data Integrity principles and familiarity with audit trail review requirements.
• General computer literacy, including proficiency in MS Office Suite (Word, Excel, PowerPoint, Outlook).
• Effective verbal communication skills with the ability to interact across all levels of the organization and departments.
• Strong technical writing skills, including experience in writing GMP documents (procedures, protocols, plans, and reports).
• Proven analytical, problem-solving, and continuous improvement skills.
• Excellent time management skills and attention to detail.
• Ability to work independently and comply with regulations.
• Physical ability to perform tasks that may require prolonged standing, sitting, and other activities necessary to fulfill job duties.
• Fluency in English or French, with professional proficiency in the second language (both 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.