Document Control Specialist Job in Redwood City 94063, California Us
POSITION: Document Control Specialist
SUPERVISOR: Sr. Director, Quality
NAME: XXX
DATE: 26 October 2011
JOB DESCRIPTION: Describe scope of the job in one paragraph.
Responsibilities include maintaining Good Manufacturing Practices (QSR); process Engineering Change Orders (ECO); maintain controlled documents, standards and regulations; organize indices, route all document change requests (ECO’s) to the appropriate department, review and file lot history records; and maintain training records.
JOB REQUIREMENTS: List tasks and responsibilities required to perform the job.
1. Process ECOs in accordance with Voyage Medical’s procedures
a. Initiate ECOs as required
b. Verify completeness and accuracy of ECOs
c. Archive early revisions of documents, standards and regulations
d. Distribute current, released, controlled documents
e. Close out ECOs and update MFP data base accordingly
f. Maintain all document control files
2. Maintain external standards and regulations
3. Review Lot History Records (LHR)
- Check for completeness and accuracy
- Close and release LHRs in the MFP Database
4. Maintain training records
a. Update MFP database when training records are submitted
b. Issue overdue reports monthly
c. Activate training sets for new employees
d. Inactivate training sets for employees exiting the company
SKILLS AND EXPERIENCE: List experience special skills required to perform the job.
1. 2 – 4 years of overall experience with document/change control process in the health care industry
2. Ability to perform multiple tasks concurrently with accuracy
3. Clear and effective communication skills
a. Proficiency in MS Word, Excel and Power Point required
b. High attention to detail and accuracy is required
c. FDA Good Manufacturing Practices (GMP)
EDUCATION: List minimum education required
High School diploma required, Associates degree preferred
EMPLOYEE SIGNATURE: ________________________________________ DATE: ________________
SUPERVISOR SIGNATURE: ________________________________________ DATE: ________________