QC Chromatography Supervisor
GSK
4 hours ago
On-site
Marietta, PA
Operations
Position Summary:
Serve as chromatography team leader and quality-system owner for the chromatography area. Partner with Analytical SMEs, Production, Quality Control, and Quality Assurance to resolve complex issues, sustain inspection readiness, and drive continuous improvement in laboratory performance and compliance. Own day-to-day QC chromatography laboratory operations to ensure release, stability, and non-routine analytical testing is executed, reviewed, and delivered to timelines in accordance with product registrations, GMP, and applicable regulatory expectations.
Front Line Leader Responsibilities:
- Create and sustain a positive, inclusive, high-performance culture and strengthen cross-functional partnership (QC, Production, Technical Services, QA, Projects).
- Provide day-to-day direction for the QC chromatography team (workload plans, sequencing priorities, resource allocation, and escalation of risks/issues).
- Maintain laboratory presence (GEMBA) to coach execution, remove barriers, and confirm safety, upkeep, quality, compliance, and output standards via GPS-based process confirmation.
- Provide people leadership (onboarding, training progression, feedback, performance management, development/succession planning, and absence/holiday coverage planning).
Compliance:
- Own chromatography methods/processes and associated GMP systems/documentation (e.g., HPLC/Empower SOPs, analytical methods, specifications, sampling/testing requirements, monographs, controlled documents); keep compliant/inspection ready.
- Ensure ALCOA++ data integrity and documentation excellence; monitor adherence and review/review escalation of questionable outcomes.
- Lead chromatography change control and implementation; assess impacts, prepare/approve documentation, deploy training, align with compendia (USP/EP), and harmonize as appropriate.
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 robust CAPA.
Continuous Improvement:
- Drive continuous improvement and inspection readiness by benchmarking best practices, implementing compliant enhancements, maintaining lab housekeeping, and supporting audits/inspections (including internal audits) with SME engagement and timely action closure.
Responsibilities:
- Manage chromatography testing workflows (HPLC, UHPLC, GC as applicable).
- Maintain system suitability, calibration records, and instrument performance monitoring.
- Approve analytical data, trend results, and related documentation.
- Participate in change control, validation activities, and method transfers.
- Support internal and external audits as a subject-matter resource.
- Promote a safe, inclusive laboratory culture and ensure safety and GMP compliance.
Qualifications:
- Bachelor’s degree in Chemistry, Biochemistry, Analytical Science, or related scientific field.
- 5+ years demonstrated leadership in a high-volume, rapid turnaround laboratory.
- 5+ years experience in a GMP/FDA regulated environment.
- 5+ years experience in Quality Control in a Chromatography laboratory.
Preferred Qualifications:
- Knowledge of GMPs, NIH Guidelines, FDA, and other regulatory requirements; experience interfacing with regulatory auditors.
- Sense of urgency, flexibility, accountability; executive leadership for people and project teams.
- Strong analysis and trending of laboratory data; ability to work in complex matrices.
- Intermediate to advanced computer skills.
- Proven internal/external customer service.
- Commitment to accuracy and quality; strong communication.
- Strong understanding of analytical methods overseen.
Work Arrangement:
- Rotational schedule may include holidays/weekends; overtime may be required.
How to Apply:
- Submit your resume and a short note explaining your chromatography leadership experience and the impact you delivered.
Serve as chromatography team leader and quality-system owner for the chromatography area. Partner with Analytical SMEs, Production, Quality Control, and Quality Assurance to resolve complex issues, sustain inspection readiness, and drive continuous improvement in laboratory performance and compliance. Own day-to-day QC chromatography laboratory operations to ensure release, stability, and non-routine analytical testing is executed, reviewed, and delivered to timelines in accordance with product registrations, GMP, and applicable regulatory expectations.
Front Line Leader Responsibilities:
- Create and sustain a positive, inclusive, high-performance culture and strengthen cross-functional partnership (QC, Production, Technical Services, QA, Projects).
- Provide day-to-day direction for the QC chromatography team (workload plans, sequencing priorities, resource allocation, and escalation of risks/issues).
- Maintain laboratory presence (GEMBA) to coach execution, remove barriers, and confirm safety, upkeep, quality, compliance, and output standards via GPS-based process confirmation.
- Provide people leadership (onboarding, training progression, feedback, performance management, development/succession planning, and absence/holiday coverage planning).
Compliance:
- Own chromatography methods/processes and associated GMP systems/documentation (e.g., HPLC/Empower SOPs, analytical methods, specifications, sampling/testing requirements, monographs, controlled documents); keep compliant/inspection ready.
- Ensure ALCOA++ data integrity and documentation excellence; monitor adherence and review/review escalation of questionable outcomes.
- Lead chromatography change control and implementation; assess impacts, prepare/approve documentation, deploy training, align with compendia (USP/EP), and harmonize as appropriate.
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 robust CAPA.
Continuous Improvement:
- Drive continuous improvement and inspection readiness by benchmarking best practices, implementing compliant enhancements, maintaining lab housekeeping, and supporting audits/inspections (including internal audits) with SME engagement and timely action closure.
Responsibilities:
- Manage chromatography testing workflows (HPLC, UHPLC, GC as applicable).
- Maintain system suitability, calibration records, and instrument performance monitoring.
- Approve analytical data, trend results, and related documentation.
- Participate in change control, validation activities, and method transfers.
- Support internal and external audits as a subject-matter resource.
- Promote a safe, inclusive laboratory culture and ensure safety and GMP compliance.
Qualifications:
- Bachelor’s degree in Chemistry, Biochemistry, Analytical Science, or related scientific field.
- 5+ years demonstrated leadership in a high-volume, rapid turnaround laboratory.
- 5+ years experience in a GMP/FDA regulated environment.
- 5+ years experience in Quality Control in a Chromatography laboratory.
Preferred Qualifications:
- Knowledge of GMPs, NIH Guidelines, FDA, and other regulatory requirements; experience interfacing with regulatory auditors.
- Sense of urgency, flexibility, accountability; executive leadership for people and project teams.
- Strong analysis and trending of laboratory data; ability to work in complex matrices.
- Intermediate to advanced computer skills.
- Proven internal/external customer service.
- Commitment to accuracy and quality; strong communication.
- Strong understanding of analytical methods overseen.
Work Arrangement:
- Rotational schedule may include holidays/weekends; overtime may be required.
How to Apply:
- Submit your resume and a short note explaining your chromatography leadership experience and the impact you delivered.