Document Control Specialist
San Jose, California
Full time, 1st Shift
6+ month contract
Responsible for the day to day management of the Site Document Control Process to ensure quality documentation meets applicable customer, regulatory, and company requirements. Ability to understand manufacturing specifications, requirements, procedures and departmental processes. Maintains quality records including filing, scanning, preparing documents for scanning and shredding of documents per procedure.
1. Verifies documentation accuracy and compliance to established procedures.
2. Trains new employees and internal customers on internal processes as well as proper document archival and retrieval of records.
3. Maintains and provides continuous quality improvement on documentation and data control practices.
4. Regulates the change process so that only approved and validated changes are incorporated in released product documentation.
5. Reviews and distributes documents and correspondence for review and ensures completion of approval process.
6. Responds to emails and/or call to answer requests for information. Verifies document accuracy to established procedures.
7. Assists in the review and approval of documentation and data control procedures.
8. Maintains accurate filing systems.
9. Ability the walk within the company campus to transfer documentation.
10. Contributes to continuous quality improvement initiatives for documentation and data control practices.
11. Supports audit activities related to documentation practices and assists in implementing corrective and preventive actions.
12. Performs all work in compliance with company policy and within the guidelines of the Quality Management System.
13. Sets priorities for workload and delegation of tasks.
14. Develops, maintains, and reports on trends specific to the Document Control process.
15. Assists with the development and implementation of Quality System policies.
16. Oversight of the Record Retention program.
Training and Education
Minimum education and/or training requirements for this position (i.e., high school diploma, college degree, and/or certification).
BS and a minimum of 3 year experience working in a regulated cGMP environment or 5+ years within Quality or Documentation; preferably in the Medical Device Industry
Number of years of experience accepted in lieu of degree and type: Minimum of six (6) years document review experience in a relevant work environment will be considered in lieu of the Associates Degree.
Minimum time and type experience required for this position.
1. BS and a minimum of 3 year experience working in a regulated cGMP environment
2. Knowledge of quality principles applicable to medical device products, including FDA QSR and ISO 13485.
3. Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
4. Strong written communication skills and attention to detail are required.
5. Ability to quickly differentiate between issues that can be resolved at this level and those that should be referred to the Director of QA/RC of higher authority.
Knowledge, Skills, and Abilities
Make decisions based on defined guidelines and procedures. Performs a wide variety of inspection and audit root cause analysis and applies problem solving skills to determine root causes and appropriate corrective actions. Is empowered to make decisions impacting product quality, quality records, and deviation resolution.