Lead Candidate · 1 month ago
QA Batch Review & Disposition Manager
Fishers, IN
Full-time
Onsite
Senior Level
6+ years expINCOG Biopharma Services is a world-class CDMO for parenteral injectable drugs located in Indianapolis, IN. They are seeking a QA Batch Review & Disposition Manager to lead batch record review processes and ensure compliance with manufacturing procedures while fostering a culture of precision and scientific rigor.
EmploymentHuman ResourcesRecruitingStaffing Agency
Hiring Manager
Megan Peacock
Responsibilities
Lead comprehensive batch record review processes for sterile injectable drug products, ensuring completeness, accuracy, and compliance with approved manufacturing procedures and specifications
Make critical batch disposition decisions (release, reject, or investigate further) based on thorough evaluation of manufacturing data, in-process testing results, and finished product testing
Ensure readiness for regulatory inspections by maintaining comprehensive batch files and being prepared to justify all disposition decisions to regulatory authorities
Train and develop team members on batch review processes, quality systems, and regulatory requirements specific to sterile injectable products
Qualification
Required
Bachelor's Degree required; degree preferred to be in Science (Chemistry, Biology, Biochemistry, Microbiology etc.)
Minimum of 6 years of Quality Assurance experience in pharmaceutical manufacturing with at least 4 years focused on batch review and disposition
Expert knowledge of cGMP requirements for batch review, release, and disposition decisions in sterile injectable manufacturing
3+ years of experience as a people leader or supervisor
Benefits
Paid time off, based on tenure
11 paid holidays
401(k) plan with company match up, vested immediately
Choice of health & wellness plans
FSA and HSA options
Onsite wellness facility
Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations
Company
Lead Candidate
Lead Candidate is a recruiting company that provides staffing, talent management, and HR solutions for the pharma sector.
Founded in 2021Newcastle Upon Tyne, Newcastle upon Tyne, GBR
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Fiona Cruickshank
Founder and Director
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