Senior QC Analyst (Chemistry)

This is a senior position that requires high volume routine testing, in-depth troubleshooting experience and the ability to work on your own initiative.

Job Summary:

• Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing, characterization, sample and data management.
• Contributes to team by ensuring the quality of the tasks/services provided by self
• Contributes to the completion of milestones associated with specific projects or activities within team

Specific Job Duties:

• With a high degree of technical flexibility, work across diverse areas within QC
• Plan and perform analyses with great efficiency and accuracy.
• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
• Report, evaluate, back-up/archive, trend and approve analytical data.
• Troubleshoot, solve problems and communicate with stakeholders
• Initiate and/or implement changes in controlled documents.
• May train others as necessary
• Participate in audits, initiatives and projects that may be departmental or organizational in scope.
• Write protocols and perform assay validation and equipment qualification/ verification.
• Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
• May conduct lab investigations as necessary
• Evaluate lab practices for compliance on a continuous basis.
• Approve lab results
• May represent the department/organization on various teams
• May interact with outside resources.
• Create APPX data files and randomisation memo to facilitate data analysis.
• LIMS data coordination of commercial and import testing on site where applicable
• May provide technical guidance.
• May represent the department/organization on various teams.

• Bachelor's degree in a science discipline.
• 2-4 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
• Strong background in Chemistry and Analytical testing is required.
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.

Knowledge:

• Understanding and application of principles, concepts, theories, and standards of GMP QC analytical laboratories.
• Deepens technical knowledge through exposure and continuous learning
• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery