What are the responsibilities and job description for the Document Control Specialist position at FTS Inc?
Job Title: Document Control Specialist
Schedule: Monday to Friday, 8:00 AM – 4:30 PM (Onsite, 100%)
Job Overview:
The Document Control Specialist is responsible for the administration of quality management system documents and records within a regulated environment. This role involves the initiation, distribution, and tracking of document changes, along with fulfilling internal and external document distribution needs.
Key Responsibilities:
- Generate, review, and maintain quality system documents (e.g., procedures, work instructions, job aids, certificates of conformance) in compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards.
- Initiate Change Controls and Document Change Requests to update procedures and processes.
- Collaborate with various departments to update and maintain processes and procedures.
- Manage document review and retention processes.
- Support or lead continuous improvement initiatives related to document control processes.
- Assist with other Quality Assurance functions, including internal audits, CAPAs, and other related tasks.
- Perform additional duties as required.
Minimum Qualifications:
- 2 years of related experience required.
- Associate or bachelor’s degree in life sciences, engineering, or a related field preferred.
- Prior experience in a manufacturing environment is a plus.
Required Skills and Experience:
- Proficiency in Microsoft Office, especially Excel.
- Experience with document management systems (e.g., ETQ or similar software) is preferred.
- Familiarity with ISO 9001 or other Quality System standards.
- Strong knowledge of ISO 13485 and 21 CFR 820 Quality Management Systems is highly preferred.
- Detail-oriented with a high degree of accuracy in execution of work.
- Ability to work independently and collaboratively within a team.
Job Types: Full-time, Contract
Pay: $29.00 - $33.00 per hour
Benefits:
- Health insurance
- Paid time off
- Referral program
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Ability to Commute:
- Kennebunk, ME 04043 (Required)
Work Location: In person
Salary : $29 - $33
