Document Control Specialist III

Document Control Specialist IIIThe position is responsible for supporting the document control system by developing, managing electronic and paper documentation using electronic document control software system (SAP) and ensuring corporate quality systems and documents are maintained in accordance with 21 CFR Part 820 and ISO-13485. Duties include administrative duties, problem solving, document related project assistance and Quality System routine operations. This position will also assist in maintaining 21CFR Part 11 controls over computerized elements of the quality system and keep abreast of regulatory directives and broadcast these requirements to management.

The Document Control Specialist III will:

* Handle tasks associated with preparing, processing and effective dating of manufacturing, standard operating procedures, house specifications, validation protocols, etc. with minimal supervision.
* Create and edit documents following the guidelines as outlined in established procedures.
* Track and manage controlled documents.
* Identify more efficient processes and work closely with management to update procedures accordingly.
* Interface with development groups, technical support groups and personnel within the manufacturing facilities in solving product documentation problems.
* Coordinate and advise personnel and/or departments concerning documentation related issues.
* Communicate problems and suggest possible solutions.
* Ensure appropriate documentation is complete, correct and that production schedules are met.
* Create labeling specifications.
* Perform documentation assignments of related tasks which are typically a focused portion of a larger project.
* Manage physical and electronic archival activities for controlled documents in accordance with applicable company retention policies and procedures.
* Document management - Scanning, Filing, Retrieval and Organization of controlled documents in accordance with applicable company policies and procedures and regulatory requirements.
* Issuing/Tracking controlled documents/labels for use in GMP manufacturing.
* Manage the SAP Training Module used to document employee training in accordance with applicable company policy.
* Issuance/tracking of laboratory notebooks, document numbers & material/product part numbers.

Qualifications

A qualified candidate will have:

* A bachelor's degree with five (5) + years document control experience in a regulated industry (i.e. Medical Device, Pharmaceuticals, etc.).
* Experience working with electronic Quality System document management systems, essential.
* Experience working with SAP or other ERP system, highly desired
* Superior verbal, written, organizational, time management, multi-tasking, attention to detail, problems solving, and interpersonal skills.
* Advanced PC Skills with standard MS Office.
* Well documented examples of leadership and change management results.
* ASQ certification, a plus.

* Strong working knowledge of QSR and regulatory requirements: 21 CFR Part 11, 21 CFR Part 820, ISO-13485.

KEYWORDS:medical device, QA, or Quality, or Quality assurance, or document control, or san diego, carlsbad
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