QC Analyst in Cincinnati, OH

Job Description

• As a QC Analyst II you will actively participate as a team member supporting the routine and non-routine testing of drug products and raw materials into the QC Laboratory.
• The Analyst performs analytical bench chemistry according to established compendia and vendor specifications.
• The ideal candidate will have strong problem solving and analytical capabilities and must be able to work independently to achieve team goals and milestones.

You will:

• Perform analyses and tests of drug products, in-process materials, release test samples or stability samples for method transfer samples, process validation samples and/or R&D products, to ensure quality standards and compliance with established specifications.
• Utilize electronic laboratory information systems such as LIMS and Empower for acquisition and processing of analytical data
• Be responsible for the accurate, timely and compliant execution of assigned projects, analytical testing and related documentation
• Serve as a mentor for more junior analysts within the team providing guidance and direction as needed
• Use risk assessment tools within your own area using knowledge, managing risk and assessing impact to make decisions
• Promote Quality and GMP by analyzing the implications of deviations, and implement solutions under guidance.
• Participate in daily direction setting huddles to provide feedback and ensure alignment on daily/weekly/monthly objectives
• Actively participate in regular one-on-one meetings with direct supervisor
• Troubleshoot problems encountered with methods and instruments - routinely solve, choosing among clearly defined alternatives
• Apply root cause problem solving principles for identification and implementation of effective corrective and preventive actions

Qualifications

• BS or higher in science related discipline, chemistry is preferred
• 2 years of Quality Control experience required, 5 years preferred.
• Minimum 2 years of experience in a pharmaceutical environment required.
• The position requires ability to run and trouble-shoot new chromatographic procedures.
• 2 years of experience with HPLC and UPLC required.
• Thorough knowledge and understanding of USP, cGMP, ICH and FDA guidelines required.
• Ability to independently solve analytical problems and view from new perspective using existing solutions required.

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