A global Pharmaceutical company whose focus is to create better health for people and a brighter future for the world. While the science and technology we advance are constantly evolving, our ambition remains. We move science forward, so we can transform more lives.

Join this team if you want to Work with globally diverse colleagues who are committed to bringing Better Health to people and a Brighter Future to the world.

Job Summary

Primary duties of the position are focused around non-laboratory support of the QC functions. Primary activities would generally include but not limited to analytical method transfer, analytical method validation, data analysis, data trending, project and testing coordination product and material specification management, inspection support, document authoring, revisions, initiating/completing quality systems, method/equipment validation and method projects activities.

Job Responsibilities

• 50-60% data analysis, data trending, project and testing coordination, support of product specification management, COA generation, material specification creation, document revisions.
• 20-30% Regulatory and/or inspection support, method projects activities, initiating/completing quality systems.
• 20% Involvement in other QC activities as required (ex. records retention)

Specific QC Focus Areas:

• Technical Services:
• Area is focused on data analysis, data trending, project and testing coordination product specification management, LIMS interface, CoA generation,(including interaction with the IT systems such as LIMS that enables electronic management of this activity), and inspection support.
• Stability:
• Area is focused on data analysis and trending of stability data, data reporting, coordination and planning of stability studies, involvement on quality events requiring stability input.
• Technical Support:
• Area is focused on various technical projects in support of the GMP laboratories, such as automation support, method projects activities (ex. method transfer and validation support activities, method monitoring), critical reagents and reference standard programs.
• Raw Materials:
• Area is focused on various projects in support of the Raw Materials department. Support includes (but not limited to) material specification creation/revision, document creation/revisions, initiating/completing quality systems, method/equipment validation and implementing operational excellence initiatives.

Education & Qualifications

• Experience in Analytical Method Transfer, Analytical Method Validation, HPLC, Bioassays, CE assays, compendial verification, biologics
• Requires a bachelor’s degree and a minimum of 5 years of related experience
• Excellent communication, interpersonal and organizational skills. Ability to work well both independently and in a team environment. Ability to prioritize work and multitask.
• Conducts work in compliance with cGMPs, safety and regulatory requirements.
• Frequent use and general knowledge of industry practices, techniques, and standards. General application of concepts, and principles. Position requires critical thinking.
• MS Office, LIMS, SAP, Trackwise, EDMS, compliance and strong science understanding