FAQs
What qualifications are required for the Document Control Specialist position?
An experienced background in Document Control or Quality Assurance within the medical device industry is preferred.
What specific tasks will the Document Control Specialist be responsible for?
The specialist will manage GMP/regulated documents, assist with transferring paper documents to EDMS, coordinate vendor maintenance, manage quality and training records, and ensure compliance with ISO regulations.
What are the key skills needed for this role?
Key skills include Quality Assurance, knowledge of FDA regulations, SOP comprehension, scanning, familiarity with ISO 13485 and GMP, document control experience, and understanding of EDMS and EQMS systems.
What level of experience is required for this position?
This is an entry-level position, but some relevant experience in the field is beneficial.
What is the work environment like at Actalent?
Actalent offers a diverse and inclusive work environment with a focus on engagement, recognition, and growth opportunities for employees.
Is Actalent an equal opportunity employer?
Yes, Actalent is an equal opportunity employer and considers all applications without regard to various protected characteristics.
How should I request an accommodation during the application process?
You can request a reasonable accommodation by emailing actalentaccommodation@actalentservices.com for various accommodation options.
Will I be involved in compliance audits?
Yes, ensuring compliance with ISO regulations and potentially participating in audits may be part of the role.
What is the significance of the 21 CFR regulation in this role?
Knowledge of the 21 CFR regulation is crucial as it pertains to the FDA's Code of Federal Regulations, which governs the medical device industry and ensures compliance with quality standards.