Senior QA Specialist Batch Disposition
Lead Candidate, Fishers, IN, United States
INCOG are looking for a Senior QA Specialist of Batch Disposition to join their rapidly growing team. Working closely with the QA Batch Manager, the Senior QA Specialist will be instrumental in supporting major QA programs related to batch review, disposition and continuous improvement.
WHAT? The Senior QA Specialist Batch Disposition will play a pivotal role in identifying and closing Operational and Quality gaps. Valuing process owners and subject matter experts, they will possess a demonstrated ability in influencing positive outcomes without direct reporting authority.
The role responsibilities are, but are not limited to:
Lead full lifecycle review and disposition of parenteral manufacturing batch records
(Formulation, Filling, Inspection, and Packaging) for Media Fills and Drug Product across all production stages.
Perform formal batch disposition determinations
by evaluating batch documentation, in-process and release testing results, CoA data, deviation investigations, and quality event closures to support release or rejection recommendations.
Execute and document SQuIPP impact assessments
for deviating events, applying ICH Q9 risk-based principles to provide scientifically defensible rationale in support of disposition decisions.
Manage QA Hold status
and serve as the primary QA point of contact
for client-facing disposition communications, coordinating release timelines and documentation packages in accordance with QTA requirements.
Cross-Functional coordination
with QC and Microbiology to ensure timely completion of all required release testing.
Provide training to QA Associates and Specialists
on batch record review, floor surveillance, and disposition workflows.
Author, review, and approve SOPs and Work Instructions ; advise on BOM/ECO builds and support Plant Automation alarm reviews.
YOU! Ideally, candidates will have a Bachelor’s degree in a scientific discipline, along with 7 years of GMP experience. Of that experience, a minimum of 5 years should come from aseptic processing within cleanroom and/or isolator environments with both QA oversight and experience as a performer or reviewer.
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WHAT? The Senior QA Specialist Batch Disposition will play a pivotal role in identifying and closing Operational and Quality gaps. Valuing process owners and subject matter experts, they will possess a demonstrated ability in influencing positive outcomes without direct reporting authority.
The role responsibilities are, but are not limited to:
Lead full lifecycle review and disposition of parenteral manufacturing batch records
(Formulation, Filling, Inspection, and Packaging) for Media Fills and Drug Product across all production stages.
Perform formal batch disposition determinations
by evaluating batch documentation, in-process and release testing results, CoA data, deviation investigations, and quality event closures to support release or rejection recommendations.
Execute and document SQuIPP impact assessments
for deviating events, applying ICH Q9 risk-based principles to provide scientifically defensible rationale in support of disposition decisions.
Manage QA Hold status
and serve as the primary QA point of contact
for client-facing disposition communications, coordinating release timelines and documentation packages in accordance with QTA requirements.
Cross-Functional coordination
with QC and Microbiology to ensure timely completion of all required release testing.
Provide training to QA Associates and Specialists
on batch record review, floor surveillance, and disposition workflows.
Author, review, and approve SOPs and Work Instructions ; advise on BOM/ECO builds and support Plant Automation alarm reviews.
YOU! Ideally, candidates will have a Bachelor’s degree in a scientific discipline, along with 7 years of GMP experience. Of that experience, a minimum of 5 years should come from aseptic processing within cleanroom and/or isolator environments with both QA oversight and experience as a performer or reviewer.
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