Siegfried
Quality Training & Documentation Specialist
Siegfried, Irvine, California, United States, 92713
Quality Training & Documentation Specialist
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Quality Training & Documentation Specialist
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Siegfried
“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.
Scope and Purpose of Position This person will support the QA Department with all Training and Document Control duties.
Responsibilities
Ensure GMP/ISO compliance in all documentation control activities to meet customer expectations based on Quality Management System (QMS) requirements.
Administrate the local Training System according to site, corporate, and regulatory standards, including building required system assets (e.g., training materials, classes, curricula) based on input from different department management, providing technical and administrative support to users, processing completed trainings, managing training records, organizing and executing site training objectives and requirements (e.g., Annual GMP Training), and monitoring and reporting training status.
Assist in the administration of Document Control / Document Management System according to site, corporate and regulatory standards, including processing document revisions/implementations, periodic review of documents, retrieval and archiving of documents, and securing 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 execution of the filing system for manufacturing documentation, including 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.
Perform any and all other duties as assigned by the immediate supervisor.
Required Knowledge, Skills And Abilities
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.
Required Education And Experience
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.
Your Benefits Paid Time Off, Health Insurance, Retirement Planning.
Salary Target Target Range: $75 - $90K.
Company Overview Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 13 sites across three continents. With a team of more than 3,800 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know‑how and experience makes us the most trusted partner in the pharmaceutical industry.
Job Details Seniority Level: Mid‑Senior; Employment Type: Full‑time; Job Function: Quality Assurance; Industries: Pharmaceutical Manufacturing and Chemical Manufacturing.
#J-18808-Ljbffr
Quality Training & Documentation Specialist
role at
Siegfried
“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.
Scope and Purpose of Position This person will support the QA Department with all Training and Document Control duties.
Responsibilities
Ensure GMP/ISO compliance in all documentation control activities to meet customer expectations based on Quality Management System (QMS) requirements.
Administrate the local Training System according to site, corporate, and regulatory standards, including building required system assets (e.g., training materials, classes, curricula) based on input from different department management, providing technical and administrative support to users, processing completed trainings, managing training records, organizing and executing site training objectives and requirements (e.g., Annual GMP Training), and monitoring and reporting training status.
Assist in the administration of Document Control / Document Management System according to site, corporate and regulatory standards, including processing document revisions/implementations, periodic review of documents, retrieval and archiving of documents, and securing 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 execution of the filing system for manufacturing documentation, including 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.
Perform any and all other duties as assigned by the immediate supervisor.
Required Knowledge, Skills And Abilities
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.
Required Education And Experience
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.
Your Benefits Paid Time Off, Health Insurance, Retirement Planning.
Salary Target Target Range: $75 - $90K.
Company Overview Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 13 sites across three continents. With a team of more than 3,800 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know‑how and experience makes us the most trusted partner in the pharmaceutical industry.
Job Details Seniority Level: Mid‑Senior; Employment Type: Full‑time; Job Function: Quality Assurance; Industries: Pharmaceutical Manufacturing and Chemical Manufacturing.
#J-18808-Ljbffr