What are the responsibilities and job description for the Document Control Specialist position at Therakos?
Job description
Provide administrative and technical support for document control and change control activities in an electronic Quality Management System (eQMS) for a regulated industry (medical device/ pharmaceutical). Provide similar support for quality events, CAPAs, and audit records in eQMS. This position works with internal partners throughout the organization and external partners, such as contract manufacturers. Provides audit and inspection back-room support.
Job requirements
Skills: Excellent communication, time management, organizational and problem-solving skills; attention to detail, multi-tasking, experience in electronic quality management system (eQMS) for medical devices and/ or pharmaceuticals.
Experience: 2 years in a similar role is strongly preferred, Arena eQMS experience a plus
Education: Bachelor’s degree in related field; Quality certifications a plus
Job responsibilities
- Ensure controlled documents are revised, approved, distributed, and archived in eQMS.
- Ensure appropriate training is conducted before making documents effective.
- Ensure proper formatting of all documents to align with company procedures.
- Communicate with internal and external partners, such as contract manufacturers, throughout document control and change control processes. Internal partners include R&D, Regulatory, Operations, and others as needed.
- Support document control, change control, quality events, CAPAs, and audit modules in eQMS. Work with external partner to resolve technical issues as needed.
- Coordinate activities within Therakos document control team to ensure requests are handled in a timely and efficient manner.
- Provide back-room support during internal audits and regulatory inspections.
Job benefits
- Medical, Dental, Vision Insurance
- Life/AD&D
- Short- and Long-Term Disability
- 401(K) with large company match
- Health Saving Account (HSA) and Flexible Spending Account (FSA) with company match
- Wellness Program
- Employee Assistance Program (EAP)
- Generous Paid Time Off (PTO)
Job Type: Full-time
Pay: From $85,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- AD&D insurance
- Dental insurance
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Retirement plan
- Vision insurance
Education:
- Bachelor's (Preferred)
Experience:
- Document Control: 2 years (Preferred)
Work Location: In person
Salary : $85,000