Spclst, Quality Control, Site Analytical Sciences

Job Description

The Site Analytical Sciences Specialist role is responsible for supporting Analytical Procedure Life Cycle through end-to-end method lifecycle management including introduction of new analytical methods, analytical transfers, SME assessment for all analytical method & equipment performance qualification, investigations, product testing and technical rationale. This work will support pipeline and commercial products by utilizing expertise in the analytical areas of separations, biochemistry, and microbiology. This role requires 2nd shift hours in supporting the West Point Laboratory Operations.

Activities Within Role:

Technical expertise to support:

• New method introduction (Validation /Tech Transfer).

• New technology introduction.

Assessment and implementation of changes for existing methods and equipment:

• Change in technical element of method e.g. Parameter change

• Change in equipment element of method e.g., column/reagent change.

• Method troubleshooting where cross-functional investigation is required.

• Technical SME for regulatory questions, audit support, reagent changes / supply issues to provided justification / rationale for analytical methods and equipment.

• Technical review of impact on Analytical methods and equipment as part of cross-functional team assessment of new/revised Global Test method / Compendia changes or updates.

• Management of PQ aspect of equipment qualification for all Quality Equipment, support IQ and OQ as required as part of capital projects.

• Analytical equipment troubleshooting.

• Initial training of end users in QC and Manufacturing and training of site analytical sciences personnel on lab systems, processes and methods where agreed.

• Investigation lead/support for lab investigations.

• Investigation lead for non-execution related investigations.

• Authoring technical documentation in support of investigation and regulatory responses.

• Analytical impact assessors on all QC Lab OPS change controls.

• Technical Impact Assessment of proposed and finalized compendial changes.

• Development and ownership of change control for new analytical methods.

• Routine Assay Monitoring and lifecycle management of analytical methods.

• Supporting digital method development.

Continuous Improvements:

• Responsible for driving a culture of Continuous Improvement by deploying company Six Sigma tools.

Coaching and Training:

• The Analytical Sciences Team Lead will provide support, guidance, and expertise to ensure the success of the Analytical Sciences group; will model the company Leadership behaviors and understand the MPS principles to drive a culture of continuous improvement building a High-Performance Organization.

This position will report to the Site Analytical Sciences Lead.

Education:

• Minimum education – Bachelors Degree in Biology, Chemistry, Engineering or related field.

Required Skills:

Adaptability, Adaptability, Analytical Instrumentation, Analytical Method Development, Assay, Behavioral Coaching, Biochemical Assays, Capital Projects, Cell-Based Assays, Dissolution Testing, Driving Continuous Improvement, GMP Compliance, Karl Fischer Titrations, Laboratory Documentation, Laboratory Safety, Microbiological Analysis, Microbiological Test, Microbiology, Molecular Microbiology, Reagent, Reagent Preparation, Software Documentation, Teamwork, Technical Specification Writing, Technical Writing {+ 1 more}

Preferred Skills:

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Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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