This role ensures documentation procedures meet quality standards, supports system implementation, and provides assistance to departments with engineering documentation needs.
The position requires effective communication, cGMP compliance, and attention to detail.
Responsibilities :
dminister and manage Facilities Engineering records and documentation following Genentech quality policies.
ssist departments with equipment and system documentation and maintain accurate Turn-Over-Packages (TOP) and Commissioning Packages.
Coordinate system implementation and prepare required documentation.
Identify process improvements and provide recommendations for workflow optimization.
Maintain open communication with management, co-workers, customers, and staff at other sites.
Support investigations, discrepancies, and corrective actions related to documentation.
Conduct work in an FDA-regulated environment.
ttend required cGMP and safety training; complete on-the-job training per procedures.
Requirement / Must Have :
dvanced knowledge of Enterprise Content Management (ECM) systems and EDMS (e.g., QualityDocs) for document management and change control.
bility to read, interpret, and produce Facilities Engineering documents.
Strong understanding of cGMP compliance and documentation standards.
Effective writing skills for technical reports, procedures, and documentation revision.
Strong organizational, analytical, and problem-solving skills.
bility to work independently with minimal supervision.
bility to lift up to 50 pounds.
Experience :
1-3 years of related experience and / or training in document control or engineering support.
Experience with relational databases (MS Access, Oracle) and project management systems (TouchPoint, Condor, Trackwise, MS Project).
Basic knowledge of SAP or similar CMMS programs.
Proficiency with Microsoft Office, particularly Word and Excel.
Qualification And Education :
High school diploma or GED required.
Combination of education and experience equivalent to 1-3 years of related work experience acceptable.
Strong interpersonal and customer service skills; detail-oriented and thorough.
Excellent oral and written communication skills.
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Document Control Specialist • Hillsboro, OR, United States
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