Document Control Specialist
- This position is an active member of Full Spectrum Group’s Quality Management System.
- This position is responsible for control of documentation, managing QMS training, and processing of document requests.
- Ensures that appropriate document approvals are obtained prior to documentation becoming effective and/or released.
- Proficient understanding and working knowledge of processes, procedures, and systems used in quality management systems.
- Organizes and update QMS training files/data base to maintain compliance.
- Leads process improvement projects related to document control systems, documentation processes and efficiencies.
- Ensures that work is being performed in accordance with documented procedures, industry standards, and regulatory requirements.
- Remains well prepared for audits by external agencies/organizations.
- Perform other duties as assigned.
- Establishes and maintains a document control system for QC procedures, work instructions and forms.
- Performs periodic internal document control system reviews and audits.
- Designs, develops, implements, and enforces best practices, processes, guidelines, systems, and technologies to support and enhance the document control function.
- Maintain Standard Operating Procedures (SOPs) and ensure their compliance to ISO 9001/17025 requirements and the business’ policies.
- Audits existing procedures and revises as needed. Implements through training.
- Keeps abreast of ISO changes & enhancements related to document control best practices.
- Minimum 3 year’s experience in Document Control in an ISO 9001 certified organization
- Working knowledge of ISO 9001 Quality Procedures.
- Recent experience facilitating ISO 9001 audits.
- Detail-oriented with the ability to multitask in a fast-paced environment.
- Excellent communication skills. Demonstrated ability to articulate ideas clearly and concisely in verbal and written form.
- Experience with current Good Manufacturing Practices (cGMP) a plus.
- Experience integrating acquired companies into an ISO certified organization.
- Occasional travel to company facilities
- Bachelor’s degree in science (chemistry, analytical chemistry biochemistry, biotechnology or similar) or equivalent lab experience.
- Experienced with Quality System Processes, change control procedures and document change orders required.
- Knowledge of lab practices, standard concepts, and test procedures for analytical instruments.
- MS office skills required.
- Ability to lift 50 pounds.