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Siegfried · 1 day ago

Quality Training & Documentation Specialist

Irvine, CA

Full-time

Onsite

Mid Level

$75K/yr - $90K/yr

4+ years exp

Siegfried is a trusted partner to the pharmaceutical industry, committed to safety, quality, and sustainability. The Quality Training & Documentation Specialist will support the QA Department with training and document control duties, ensuring compliance with GMP/ISO standards and managing training records and documentation processes.

BiotechnologyHealth CareManufacturingMedicalPharmaceutical

Responsibilities

Ensure GMP/ISO compliance in all documentation control activities to meet customer's expectation based on Quality Management System (QMS) requirements

Administrate the local Training System according to site, corporate, and regulatory standards to include: building of required system assets (e.g., training materials, classes, curricula) based on input from the different department management, technical and administrative support to users, processing of completed trainings, management of training records, organization / execution of site training objectives and requirements (e.g., Annual GMP Training), and monitor / report training status

Assist in the administration of Document Control / Document Management System according to site, corporate and regulatory standards to include: processing of document revisions/implementations, periodic review of documents, retrieval and archiving of documents, and security of physical document storage and electronic copies

Assist in the management of the Document Control area to ensure security and availability of materials and supplies to accomplish the Document Control mission

Assist in the management of the logbook program ensuring timely issuance and reconciliation of logbooks

Assist in the maintenance and execute of the filing system for the manufacturing documentation, to include: issuance of batch records, archival of executed batch records, and return of customer owned documents

Provide sound Quality guidance and enforcement of Document Control and Training procedures and fundamentals

Provide training on Document Control owned and Training systems

Support the Quality Unit during customer and regulatory audits and inspections

Any and all other duties as assigned by immediate supervisor

Qualification

GMP complianceDocument controlTraining administrationQuality Management SystemRecords managementCustomer servicePublic speakingComputer literacyOral communicationWritten communication