The Document Control Coordinator will be an integral member of the Quality team.
The primary responsibility is to maintain the daily activities within the Document Control function.
The ideal candidate has knowledge and experience working in regulated environments (i.e.
ISO 13485, 21 CFR Part 820, 21 CFR Part 11) and sufficient knowledge and experience working in Quality to operate with minimal supervision.
This position reports to the Quality Assurance Manager.
Key Responsibilities:
Participate in the development, implementation and maintenance of the Quality Management System
Work on Document Control activities either independently or with minimal supervision.
Ensure documentation and data related to the requirements of the Quality System are controlled in a manner, which ensures integrity and accessibility.
Ensure document control activities such as document management, version control and distribution management are executed in a timely fashion and in accordance with regulatory requirements.
Update and maintain document control procedures and record keeping database.
Perform training on Document Control process
Reviews all documents for change to ensure the use of correct templates and key quality requirements, and resolves issues with the initiator of the change.
Ensure that the current revision of a controlled document is clearly defined in order to preclude the use of non-applicable documents.
Maintenance of all applicable records such as validation reports, test reports, batch records and training records (internal and external training) as defined by applicable regulations and standards.
Support the maintenance of periodic document review
Duties also may include word processing, filling quality records, and other project related activities as needed.
Support the Training program by assigning document trainings for new and revised documents
Assist in the creation of training plans at onboarding
Create and present Quality metrics as needed
Support audits for licensure and accreditation documents submission
Additional duties as assigned
Required education and experience :
Experience working in a regulated Medical Device or Pharma environment is required
Strong desire to work in a demanding, dynamic, hands-on startup environment
Ability to primarily work independently
Bachelor’s in life or computer science preferred
3+ years’ experience in a document control role required developing/enhancing, implementing, and maintaining a documentation system which demonstrates compliance with applicable regulatory requirements, or similar document creation, filing/archiving experience
Candidate must be detail oriented, to review documents with specific requirements in mind and ensure the posting process is completed
Ability to prioritize and organize workload to meet business needs and turnaround time requirements
Strong abilities in Microsoft Office applications
Excellent technical writing and verbal communication skills
Expert in Microsoft Word, Excel, and Power Point
Knowledge of electronic document control management systems such as Visual Vault is a big plus
Ability to work in a supporting role and communicate with cross functional teams and partners at all levels in the organization
Job Type: Full-time
Pay: From $36.00 per hour
Benefits:
401(k)
401(k) matching
Dental insurance
Flexible spending account
Health insurance
Life insurance
Paid time off
Vision insurance
Schedule:
8 hour shift
Monday to Friday
Experience:
Microsoft Office: 1 year (Preferred)
Work Location:
One location
Work Remotely:
No
Work Location: One location