QC Immunology Supervisor
GSK
4 hours ago
On-site
Marietta, PA
Operations
Position Summary
- Provide leadership to the immunology/colorimetry team.
- Ensure samples are tested and reviewed per predefined timelines (Utilities, Finished Product, Raw Materials, Retention Samples, Validation Samples).
- Drive projects to closure in support of site goals.
- Serve as owner for Immunology/colorimetry Quality System Events.
- Ensure lab processes/tests are safely executed and compliant with GMP/regulatory requirements.
- Escalate issues and successes for the Immunology team.
Front Line Leader Responsibilities
- Create and sustain a positive, inclusive, high-performance culture; strengthen cross-functional partnership (QC, Production, Technical Services, QA, Projects); reinforce shared ownership aligned to site and objectives.
- Provide day-to-day direction for QC Immunology by developing workload plans, sequencing priorities, allocating resources, and escalating risks/issues for safe, compliant, on-time “right first time” execution.
- Maintain laboratory presence (GEMBA) to coach execution, remove barriers, and confirm safety, quality, compliance, and output using GPS-based process confirmation.
- Provide people leadership: onboarding, training progression, feedback, performance management, development/succession planning, and absence/holiday coverage.
Compliance
- Own immunology/colorimetry methods/processes and GMP documentation (e.g., Plate Reader, Western Blot, SOPs, analytical methods, specifications, sampling/testing requirements, monographs, controlled documents); keep inspection-ready; delegate/coach senior team members.
- Participate in LES implementation for Business Cutover (BCO) and master data updates in SAP.
- Ensure ALCOA++ data integrity and documentation excellence; monitor adherence; review results/data for compliance and escalate questionable outcomes.
- Lead immunology/colorimetry change control and implementation; assess impacts; prepare/approve documentation; deploy training; align with USP/EP compendia.
Problem Solving
- Identify, escalate, and resolve atypical/questionable results to protect product decisions and delivery timelines.
- Lead OOS/atypical results, deviations, and laboratory investigations to timely closure using structured root cause methods (e.g., DMAIC) and effective CAPA.
Continuous Improvement
- Drive continuous improvement and sustained inspection readiness by benchmarking best practices; implement compliant enhancements; maintain lab housekeeping; support audits/inspections (including internal audits) via SME engagement and timely action closure; utilize GPS tools.
Qualifications
Required
- Bachelor’s degree in biology, Immunology, Biochemistry, or related scientific field.
- 5+ years’ laboratory experience in high-volume, rapid turnaround testing.
- 5+ years’ experience in a GMP/FDA regulated environment.
- 5+ years’ experience in a Quality Control environment in an Immunology or bioassay laboratory.
Preferred
- Master’s degree in Immunology, Molecular Biology, or related field.
- Knowledge of GMP, NIH Guidelines, FDA, and other regulatory requirements; ability to interface with auditors.
- Ability to serve as an SME; sense of urgency, flexibility, accountability.
- Executive capability to lead people and project teams; communicate at all levels.
- Willingness to travel abroad; experience in high-complexity matrix environments.
- Ability to follow written procedures and accurately document results; intermediate computer skills.
- Proven internal/external customer service; stay current on field developments and GSK-Bio Standards.
- Ability to manage multiple/repetitive tasks with attention to detail; integrity with balanced priorities.
Work Arrangement
- Rotational schedule may include holidays/weekends; overtime may be required.
How to Apply
- Submit your resume and a short note about your immunology leadership experience and the outcome you delivered.
- Provide leadership to the immunology/colorimetry team.
- Ensure samples are tested and reviewed per predefined timelines (Utilities, Finished Product, Raw Materials, Retention Samples, Validation Samples).
- Drive projects to closure in support of site goals.
- Serve as owner for Immunology/colorimetry Quality System Events.
- Ensure lab processes/tests are safely executed and compliant with GMP/regulatory requirements.
- Escalate issues and successes for the Immunology team.
Front Line Leader Responsibilities
- Create and sustain a positive, inclusive, high-performance culture; strengthen cross-functional partnership (QC, Production, Technical Services, QA, Projects); reinforce shared ownership aligned to site and objectives.
- Provide day-to-day direction for QC Immunology by developing workload plans, sequencing priorities, allocating resources, and escalating risks/issues for safe, compliant, on-time “right first time” execution.
- Maintain laboratory presence (GEMBA) to coach execution, remove barriers, and confirm safety, quality, compliance, and output using GPS-based process confirmation.
- Provide people leadership: onboarding, training progression, feedback, performance management, development/succession planning, and absence/holiday coverage.
Compliance
- Own immunology/colorimetry methods/processes and GMP documentation (e.g., Plate Reader, Western Blot, SOPs, analytical methods, specifications, sampling/testing requirements, monographs, controlled documents); keep inspection-ready; delegate/coach senior team members.
- Participate in LES implementation for Business Cutover (BCO) and master data updates in SAP.
- Ensure ALCOA++ data integrity and documentation excellence; monitor adherence; review results/data for compliance and escalate questionable outcomes.
- Lead immunology/colorimetry change control and implementation; assess impacts; prepare/approve documentation; deploy training; align with USP/EP compendia.
Problem Solving
- Identify, escalate, and resolve atypical/questionable results to protect product decisions and delivery timelines.
- Lead OOS/atypical results, deviations, and laboratory investigations to timely closure using structured root cause methods (e.g., DMAIC) and effective CAPA.
Continuous Improvement
- Drive continuous improvement and sustained inspection readiness by benchmarking best practices; implement compliant enhancements; maintain lab housekeeping; support audits/inspections (including internal audits) via SME engagement and timely action closure; utilize GPS tools.
Qualifications
Required
- Bachelor’s degree in biology, Immunology, Biochemistry, or related scientific field.
- 5+ years’ laboratory experience in high-volume, rapid turnaround testing.
- 5+ years’ experience in a GMP/FDA regulated environment.
- 5+ years’ experience in a Quality Control environment in an Immunology or bioassay laboratory.
Preferred
- Master’s degree in Immunology, Molecular Biology, or related field.
- Knowledge of GMP, NIH Guidelines, FDA, and other regulatory requirements; ability to interface with auditors.
- Ability to serve as an SME; sense of urgency, flexibility, accountability.
- Executive capability to lead people and project teams; communicate at all levels.
- Willingness to travel abroad; experience in high-complexity matrix environments.
- Ability to follow written procedures and accurately document results; intermediate computer skills.
- Proven internal/external customer service; stay current on field developments and GSK-Bio Standards.
- Ability to manage multiple/repetitive tasks with attention to detail; integrity with balanced priorities.
Work Arrangement
- Rotational schedule may include holidays/weekends; overtime may be required.
How to Apply
- Submit your resume and a short note about your immunology leadership experience and the outcome you delivered.