Actalent
Location
San Mateo, CA | United States
Job description
Description:
• Facilitates end to end management of the documents, including training requirements impact assessment, reviewing document content to ensure changes are appropriately following defined processes/procedures, and effective management and implementation of related documents.
• Manages controlled documentation through the document lifecycle and compliance with applicable procedures and regulatory requirements.
• Collaborates with Business Owners to ensure document changes and training requirements impact assessment are effectively managed to meet timelines.
• Delivers quality customer service and domain knowledge when working with stakeholders.
• Reviews documents to ensure changes are documented and justified in accordance with procedural requirements.
• Identifies continuous improvements to drive efficiency of the document control and training processes.
• Train users on document management and training processes, as required.
• Collect and provide data on key performance indicators.
Skills:
Document control, Gmp, Data entry, Microsoft office, electronic document management system edms, veeva vault, ms word, ms excel
Qualifications:
Science degree - TBD on requirement, BS or AS
2-3 years of GMP experience
1-2 years of EDMS experience (Electronic Document Management System)
They use Veeva Vault - they are willing to train on this system if someone has used a different system
Knowledge and experience with MS Word and Excel
Pharma industry preferred;
• Provides additional support and assistance on tasks and projects as directed by management.
• Participates as required in training on issues affecting own area of work.
• Demonstrates knowledge of Document Control fundamentals, Quality Systems and Compliance with current Good Manufacturing Practices (GMPs).
• Demonstrates knowledge of the processes and impact of document management, and the relationship between the document change process and products.
• Demonstrates basic understanding of the current pharmaceutical industry and applicable regulations including 21 CFR, GxP, ICH, etc.
• Demonstrates working knowledge of Electronic Document Management Systems (EDMS).
• Demonstrates knowledge of document hierarchy and document types.
• Demonstrates the ability to apply basic compliance requirements in own work area with applicable regulatory requirements.
• Demonstrates ability to perform detail-oriented work with a high degree of accuracy.
• Demonstrates problem solving skills.
• Demonstrates proficiency in Microsoft Office applications.
• Demonstrates strong verbal, written and interpersonal communication skills.
Experience Level:
Intermediate Level
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] (%[email protected]) for other accommodation options.
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