Operations QA Tech Specialist
Core
Ensures process compliance and quality in pharmaceutical manufacturing operations, including line clearances, batch record verification, and adherence to cGMPs.
Role type
Operations Quality Assurance Technician
Builds
Pharmaceutical manufacturing batches and packaging
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP knowledge, batch record verification, line clearance procedures, audit execution, data trend analysis, SOP implementation, change control management, CAPA management, risk assessment, FDA regulation compliance
Preferred skills
SAP proficiency, QMS experience, ASQ CQIA or CQIA certification, pharmaceutical processing experience
Technologies
SAP, Microsoft Excel
Responsibilities
Perform line clearances for manufacturing and packaging; conduct routine audits of processes and documentation; monitor production for procedure adherence; verify and approve batch records and labeling; collect and analyze quality metrics; support investigations and change controls; write or review SOPs.
Seniority
Mid-level, hands-on IC
