Senior Associate QC (24/7 Shift)

Under minimal supervision, responsible for one or more of the following activities in QC including HPLC, CE, GELs, analytical testing, characterization, method transfer, sample and data management and equipment maintenance.

• 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

This role will support manufacturing operations, as such work will be as part of a 24/7 shift pattern and flexibility may be necessary.

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Specific Job Duties:
• With a high degree of technical flexibility, work across diverse areas within the lab.
• Plan and perform routine analyses with 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.
• 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.
• Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
• Approve lab results.
• May participate in lab investigations.
• May provide technical guidance.
• May train others.
• May contribute to regulatory filings.
• May represent the department/organization on various teams.
• May interact with outside resources.