Specialist, Operational Quality Control
Core
Provide quality and compliance oversight for Micro Sterility Assurance Laboratory operations, ensuring testing activities adhere to GMP and SOPs.
Role type
Specialist, Operational Quality Control (Laboratory)
Builds
Sterility assurance testing processes and compliant laboratory documentation
Domain
Life Sciences / Microbiology / GMP-regulated Laboratory
Required skills
GMP Compliance, Deviation Management, CAPA Management, Laboratory Documentation Review, Root Cause Analysis, Data Integrity, Change Control, Inspection Readiness, Trend Monitoring, Laboratory Safety
Preferred skills
Microbiological Testing Experience, Continuous Improvement (MPS), Process Standardization, Audit Support
Technologies
Laboratory Information Management Systems (LIMS), Microbiological Analytical Equipment
Responsibilities
Review laboratory documentation and data for accuracy and compliance; Assist in deviation investigations and follow-up actions; Support quality system activities including change control and CAPA; Participate in root cause analysis and problem-solving; Monitor trends and recommend corrective actions; Support internal audits and inspection readiness.
Seniority
Individual Contributor, Specialist