Associate Document Control Specialist

Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world's leading biotech companies, with multiple products on the market and a promising development pipeline.

RESPONSIBILITIES:

• Responsible for the administration and management of Facilities Engineering records in an effective and efficient method within the Hillsboro Oregon facility.
• Prepare and organize documentation procedures following 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 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 activities.
• 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

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.

Please note: This is a 12 Month Contract with the possibility of extension, requires onsite M-F, and is not eligible for C2C.