Specialist, Quality Control Execution Support; 2nd Shift

## Specialist, Quality Control Execution Support (2nd Shift)
Apply:
Not Applicable:
USA
- Pennsylvania
- West Point:
Full time:
Posted Today:
End Date:
October 7, 2026 (7 days left to apply):
R420012
** Job Description
**** Purpose of Role:
** The Quality Control Execution Support Specialist role (
** 2nd shift**) is responsible for supporting Analytical Procedure Life Cycle through end-to-end method lifecycle management including introduction of new analytical methods, act as the receiving unit for 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 (Direct to QC Validations /Tech Transfer Receiving Lab Support).
* 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.
* 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 support for lab 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 updates to 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 our 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 our Company Leadership behaviors and understand the MPS principles to drive a culture of continuous improvement building a High-Performance Organization.

Reports to:

West Point Site Analytical Sciences, Quality Control Execution Lead
** Behaviors, Job Experience and Qualifications
**** Key Behaviors:
** Win as one team.

Focus on what matters.

Act with urgency.

Experiment, learn and adapt.

Embrace varied perspectives and inclusion.

Speak Up and be open-minded  
** Required Education.*
* * Bachelor's degree (1-3 years related work experience) or Master's degree (0 years related work experience) – in Chemistry, Biology, Microbiology or related field.
** Required Experience & Skills.
*** 1+ years 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…