Senior QA Specialist
Core
Ensures compliance with regulatory requirements and corporate quality standards while managing QA operations and data integrity for analytical testing.
Role type
Senior QA Specialist (Bio/Pharmaceutical)
Builds
Compliance with regulatory frameworks and quality systems for drug product/substance testing
Domain
Life Sciences / Bio-Pharmaceutical / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP/GLP application, regulatory guidance knowledge, data review, audit response preparation, ELN/LIMS proficiency, analytical report release, SOP assignment, training documentation, investigation writing
Preferred skills
Waters Empower software experience, USP/EP compendia knowledge, team lead experience
Technologies
ELN, LIMS, Waters Empower
Responsibilities
Coordinate and document training for new employees on electronic laboratory systems and QMS; Support continuous improvement of the Quality System via regulatory review; Perform QA review and release of analytical reports; Assist with audit responses and regulatory correspondence; Apply GMP/GLP in all areas of responsibility; Conduct core training for new hires including account setup and documentation grading.
Seniority
Senior, hands-on IC with team lead experience
