Batch Release Specialist, Quality Assurance Operations
Core
Managing the release of manufactured batches by verifying compliance with quality systems and cGMP regulations.
Role type
Senior Quality Assurance Batch Release Specialist
Builds
Released pharmaceutical batches for distribution
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Batch disposition, cGMP compliance, Root Cause Analysis, Risk Management, Technical Writing, Process improvement, Team mentoring, Safety protocols
Preferred skills
TrackWise, DMS, SAP, LIMS, 21CFR210/211/820, ICH Q7/Q13485, Part 11
Responsibilities
Disposition of batches manufactured at the LHI site, Collaborating with teams to ensure batch disposition tasks are finished, Mentoring junior staff on batch records, Implementing changes to the batch release process, Identifying improvements in Quality Systems, Maintaining quality systems and cGMP compliance
Seniority
Senior, hands-on IC
