**_MAIN PURPOSE OF ROLE_**
This position executes Documentation Control activities which includes:
- Activities regarding Windchill and SAP systems per applicable Quality Systems procedures.
- Translation services between English and Spanish for the applicable controlled documentation.
- Effective exceution and support on the Quality Records activities in the Documentation Control area, via the receiving, processing, scanning, review, and archiving of quality records.
- Guiding site and BU Change Control system users and Documentation Clerks.
- Resolving issues related to Change Control system and Quality Records management.
- This function will work with site projects providing technical support as required
**_ MAIN RESPONSIBILITIES_**
Assure effective change request administration.
- Ensure that all change requests comply with procedure requirements.
- Coordinate and control the processing of all documentation change requests, procedures, and appropriate documentation.
- Coordinate implementation of change requests with all affected areas/facilities.
- Prioritize and schedule completion of approved change requests.
- Work with remote facilities as necessary to assist in changes that affect multiple locations.
- Maintain appropriate logs and records, if required.
- Provide assistance to change requestors in updating documents, creating or updating Bills of Materials, parts, routers and submitting change requests, etc.
- Support the translation of controlled documents between English and Spanish, writing, editing, and maintaining the documentation requiring translation in a controlled fashion
Maintain accurate configuration control
- Control part numbers and revision level assignments.
- Maintain product configurations by ensuring the accuracy of Bills of Materials.
- Control Device Master Records.
- Maintain item master accuracy by updating additions, deletions, and other changes as required.
Assure effective documentation control administration
- Technical written translation services between English and Spanish for the applicable controlled documentation and enforcing adherence to written documentation policies and procedures.
- Monitor and prioritize routine documentation activities and requests to ensure customer expectations are met.
- Distribute notifications and updated documents to applicable areas, as required.
- Proofread documents for accuracy and adherence to policies, as necessary.
Support translation activities of controlled documents, as required.
- Responsible for maintenance of documentation databases.
- Review all quality records at the receipt for accuracy of identification and quantity.
- Archive quality records in the designated area ensuring that archived records are readily available.
- Support Customer requests for the retrieval of archived documents for review, copy, and/or scanning.
- Prepare quality records for scanning, either in-house or by an approved supplier.
- As required, scan documents for electronic archiving purposes.
- Review scanned documents to ensure accuracy and legibility
Provide technical support to facility projects
- Support project teams to ensure change requests are implemented to meet deadlines.
- Support facility projects to ensure accurate product configuration and documentation of new/existing products.
- Provide technical support to departmental activities to troubleshoot documentation and ERP system problems and provide solutions.
**_ QUALIFICATIONS_**
- Bachelor's degree in Engineering, Business Administration, English-Spanish Translator or another related field
- 1+ years work experience
- Advance Commands of English
- At least 1 year of experience in an FDA or ISO controlled industry is preferred.
- Knowledge of ERP/PDM databases (i.e.
SAP, Mfg-Pro, Windchill) preferred.
- Knowledge of FDA, GMP, and ISO 13485 is preferred