Precision For Medicine specializes in supporting life sciences companies with services tailored to accelerate clinical research and personalized medicine. With a global presence and innovative solutions, the company is dedicated to driving precision healthcare forward.
Responsibilities of a Document Control Specialist
As a Document Control Specialist, your core duties will revolve around maintaining and managing controlled documents and records, along with providing administrative support to the quality assurance team. Key responsibilities include:
Quality Assurance and Document Control
- Overseeing electronic document control workflows for new and existing Quality System Documents.
- Tracking document lifecycles, from drafting to obsolescence.
- Ensuring compliance with internal standards, proper formatting, and readability of documents.
- Reporting gaps in documentation to senior management and providing guidance for corrections.
- Assisting with revisions during quality system integration processes.
- Assigning training workflows for employees on revised or new procedures.
- Coordinating periodic document reviews and ensuring document security.
- Uploading documents to the PLN portal or internal sites.
Training
- Conducting training sessions for employees on the electronic quality management system.
Audit Support
- Preparing, locating, and reconciling document requests for audits.
- Ensuring timely responses to documentation requirements.
- Preparing welcome packets and updating procedure binders for audits.
- Compiling employee training binders for audit review.
Additional Duties
- Performing other responsibilities as assigned by management.
Qualifications and Skills
Minimum Requirements
- Bachelor’s degree in a relevant field.
- 1-3 years of experience with ISO 9001/13485 standards.
- Knowledge of quality systems and document control in clinical research organizations.
Additional Requirements
- Obtain Document Control Certification within the first year.
- Proficiency in Microsoft Office applications.
- Strong administrative skills with the ability to meet deadlines.
- Flexible and adaptable to changing priorities and assignments.
- Excellent communication skills with fluency in English (reading, writing, and speaking).
