Associate Document Control Specialist

Title : Associate Documentation Control Specialist

Location : Hillsboro, OR

Duration : 12 Months

RESPONSIBILITIES :

Responsible for the administration and management of Facilities Engineering records in an effective and efficient method within the Client, Hillsboro Oregon facility.

Prepare and organize documentation procedures following Client quality policies.

Assist departments with equipment and system documentation. Coordinate system implementation and prepare documentation as necessary.

Identify specific process improvement as needed and provide recommendations concerning established workflows.

Work directly with Facilities Engineering and various Quality organizations.

Maintain open communication with management, co-workers, customers and counterpart staff in other sites.

Conduct work in an FDA regulated environment.

Take ownership of responsibilities and drive change both locally and within the Client network.

Manage all Turn-Over-Packages (TOP) and Commissioning Packages from HTO site projects.

Maintain open communication with management, co-workers, customers and counterpart stain in other sites.

QUALIFICATIONS / REQUIREMENTS :

Proficient in Enterprise Content Management (ECM) application used for archiving, managing and accessing Corporate Engineering Document, drawings, and project documents (TOPs and Commissioning documentation). Proficient in FileMaker Pro.

Point of contact for managing and archiving Maintenance activities using QualityDocs document Management.

Advance knowledge of ECM and EDMS to support the role of Business Process Manager for HTO.

Develop and document workflow practices and routine tasking for these activites.

Provide document support for investigations, discrepancies, and corrective actions.

Provide daily assistance to HTO personnel as needed.

The ability to read, interpret and produce Facilities engineering documents.

Thorough knowledge of cGMP compliance.

Must possess advance documentation skills to ensure project files and system documentation is maintained at superior level.

Proficient in EDMS (QualityDocs) for change management of Facilities Engineering documents.

Demonstrate effective writing skills including preparing technical reports, the revision of various technical documentation and procedures.

Proficient in office products specifically Microsoft Word

Ability to work overtime or temporarily modify shift schedule to support site obligations as needed.

Effectively work with minimum or no supervision

Ability to life 50 pounds.

TRAINING DUTIES :

Attend all required cGMP training as required by department policy

Attend all required Safety training as required by Department policy

Complete on the job training using established training procedures.

EDUCATION / TRAINING :

High school diploma or general education degree (GED); one to three years related experience and / or training or equivalent combination of education and experience.

Proficient with relational database systems (e.g., MS Access, Oracle), project management systems e.g., TouchPoint, Condor, Trackwise, MS Project, date reporting tools (e.g., MS Access Excel, etc. , Basic knowledge of SAP, or another similar CMMS program.

Must have advanced knowledge with Windows environments. Must be detail oriented, accurate and thorough.

Must have helpful disposition and friendly, outgoing personality with strong customer service skills.

Must have excellent problem-solving skills and persistence to resolve outstanding issues. Must have strong analytical skills.

Must have excellent organization skills.

Strong personal skills are a must.

Proficient in both oral and written communications is essential.

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