Quality Training & Documentation Specialist

Siegfried•Irvine, CA

61d•$75 - $90

About The Position

Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact. Your Role: Scope and Purpose of Position This person will support the QA Department with all Training and Document Control duties. Your Profile: 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.

Requirements

Understanding of GMP at an academic and conceptual level and adherence at a tactical level
Understanding of training fundamentals for effectiveness and compliance
Understanding of document control fundamentals
Customer service with focus on order and request fulfillment
Strong organizational, records/database management, and area housekeeping skills
Good computer literacy with particular focus on Windows platform and applications such as Adobe and Office (Word, Excel)
Good oral and written business communication
Public speaking
Ability to lift 15 to 25 lbs.
Bachelor’s Degree or equivalent combination of education and experience
4 years working in a Quality role in a GMP environment / 8 years if previous experience is non-Quality role

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.