Specialist, Quality Control

MSD

13d•Hybrid

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. 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 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's Leadership behaviors and understand the MPS principles to drive a culture of continuous improvement building a High-Performance Organisation.

Requirements

Minimum 1 year of relevant post-degree work experience in GMP Manufacturing or Laboratory environment, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting
1+ years (with BCs) working on analytical method introduction and qualification within the biopharmaceutical and/or pharmaceutical industry
Experience with analytical methods (HPLC, cGE, ELISA, Bioassays, PCR, compendial methods, Microbial methods, cell-based assays)
Flexible, self-motivated & ability to manage multiple priorities
Strong project management and stakeholder management skills required with demonstrated ability to influence across internal and external stakeholders
Proven ability to work as part of an interdependent team but also on own initiative to ensure progression of priorities
Experience in problem solving (facilitation & application of tools), risk management, decision making & trouble shooting skills
Excellent communication skills – verbal, written, presentations
Ability to coach and support development of AS&T Scientists and QC technicians within AS&T and QC teams
Provide leadership and expertise for preparation of regulatory submissions, inspection readiness, and support health authority inspections – including but not limited to interaction with inspectors, responding to observations and monitoring of commitments
Accountability
Adaptability
Analytical Instrumentation
Analytical Method Development
Biochemistry
Business Management
Capital Projects
Dissolution Testing
Driving Continuous Improvement
GMP Compliance
IS Audit
Karl Fischer Titrations
Laboratory Documentation
Laboratory Safety
Microbiological Analysis
Microbiological Test
Microbiology
Molecular Microbiology
Polymerase Chain Reaction (PCR)
Problem Solving
Project Management
Quality Control Management
Risk Management
Stakeholder Management

Responsibilities

New method introduction (Validation /Tech Transfer)
New technology introduction
Assessment and implementation of changes for existing methods and equipment
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
Driving a culture of Continuous Improvement by deploying Six Sigma tools
Provide support, guidance, and expertise to ensure the success of the Analytical Sciences group
Model the company's Leadership behaviors and understand the MPS principles to drive a culture of continuous improvement building a High-Performance Organisation