Spclst, Quality Control, Site Analytical Sciences

Merck & Co. • West Point, PA

84d • Onsite

About The Position

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.

Requirements

• Minimum education - Bachelor's Degree in Biology, Chemistry, Engineering or related field.
• 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 Preparation.
• Software Documentation.
• Teamwork.
• Technical Specification Writing.
• Technical Writing.

Responsibilities

• Technical expertise to support new method introduction (Validation /Tech Transfer).
• New technology introduction.
• Assessment and implementation of changes for existing methods and equipment.
• Method troubleshooting with cross-functional investigation.
• Technical SME for regulatory questions, audit support, reagent changes/supply issues.
• Technical review of impact on Analytical methods and equipment.
• Management of PQ aspect of equipment qualification for all Quality Equipment.
• Analytical equipment troubleshooting.
• Initial training of end users in QC and Manufacturing.
• Investigation lead/support for lab investigations.
• Authoring technical documentation in support of investigation and regulatory responses.
• Analytical impact assessors on all QC Lab OPS change controls.
• Development and ownership of change control for new analytical methods.
• Routine Assay Monitoring and lifecycle management of analytical methods.
• Supporting digital method development.
• Driving a culture of Continuous Improvement by deploying company Six Sigma tools.
• Coaching and Training for the Analytical Sciences group.

What This Job Offers

• Job Type: Full-time
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree