Document Control Specialist
The Document Control Specialist is responsible for managing, organizing, and maintaining company documents and records to ensure accuracy, accessibility, and compliance with regulatory standards. Duties include document review, version control, distribution/notification, archiving, and ensuring adherence to company policies and procedures. Collaborates with teams to support efficient document workflows and implements systems to track and control documentation. Strong organizational skills and attention to detail are essential.
As part of our team, your core responsibilities will be:
- Establish and maintain document control systems to manage the creation, review, approval, distribution, and archiving documents. Owns document control eQMS software set up, implementation, use and maintenance, and manages license use for all processes within the eQMS system.
- Execute document change control processes to ensure standardization, accuracy, and completeness of documents proper to release.
- Train employees in document control processes and tools as needed.
- Ensure proper version control of documents and prevent unauthorized changes.
- Collaborate with teams across departments to ensure timely access to necessary documentation. Respond promptly to internal and external document requests.
- Stakeholder in the development, implementation, and continued improvement of quality systems within the Quality department.
- Responsible for providing data and information to support the quality data reports.
- Responsible for employees training on Quality System (e.g., training assignment to new hire, training records on time tracking, and etc.).
- Take responsibility for the ongoing maintenance, audit and continuous improvement of the Quality Management System documentation, to ensure compliance.
- Plan, create, update part and document numbering, support and collaborate with other functions on changes and change request submission through eQMS and support change orders and item creation, review, approvals and releases in PLM systems, as needed.
- Interacts with cross-functional departments to provide guidance on documents, templates, file naming, training and eQMS.
- Ensuring compliance with regulatory requirements and company policies regarding document management.
- Coordinate timely completion/review of the change orders, CAPAs and other processes as assigned.
Qualifications
Baseline skills/experiences/attributes:
- The candidate will have 5+ years experience in documents control or in another QA role. Document control process for medical, biotech or IVD industries
- Communication, both oral and written, with the ability to communicate frequently, clearly, and timely while keeping both internal and external parties aligned to deliver impact at pace
- Tools including experience working in Master Control, Arena or similar electronic systems, Microsoft office products, and more
- Problem solving, with very strong analytical skills which can be utilized to proactively identify and address issues with a solution-oriented approach with excellent time management skills
The estimated base salary range for this role based in the United States of America is: $85,000 - $115,000. Compensation decisions are dependent on several factors including, but not limited to, level of the position, an individual’s skills, knowledge and abilities, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all full-time employees are eligible for our discretionary bonus program and equity as part of the compensation package.
Quantum-Si does not accept agency resumes.
Quantum-Si is an E-Verify and equal opportunity employer regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability or Veteran status. All your information will be kept confidential according to EEO guidelines.
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