Sr Document Services/Learning and Development

Essential Duties and Responsibilities

• Identifying and managing all controlled documentation to ensure compliance with operational, corporate and regulatory requirements.
• Providing effective and efficient documentation and records management.
• Coordinating the scheduling of formal document reviews for site documentation.
• Maintains file system of the current drawing revisions and documents of external origins.
• Communicating changes to document control procedures or other relevant information which have been updated or added.
• Disposing or destroying records and documents in a secure and proper way when retention periods expire.
• Scan and enter material certifications and SDS into the system.
• Conduct Risk Assessments and Job Hazard Analysis if OSHA 10-hour certified.
• Enter Equipment Risk Assessments and Job Hazard Analysis into HQMS.
• Support Customer and Regulatory audits by pulling required documentation.
• Prepare work orders for production team and verify that all required documentation is attached.
• Read blueprints, data, manuals, or other materials to determine specifications, inspection, and testing procedures, adjustment methods, certification processes, or measurement instruments required for work orders.
• Measure and document core/mandrel dimensional readings for lot release.
• Review and approve inspection results and device history records for completeness.
• Create the Certificate of Conformance and all customer requirements for shipping.
• Reading and interpreting manufacturing procedures, engineering drawings, customer specifications and inspection procedures and comply with their requirements.
• Understand Good Documentation Practices.
• Assist in the investigation, control and disposition of nonconforming materials.
• Maintain data files, training and competency records.
• Analyze and trend quality metrics to identify opportunities for improvement and participate in continuous improvement projects.
• Identify, facilitate, and perform all necessary measures of the Quality Management System as directed by the Quality Manager.
• Create inspection sheets, input data, and inspect core mandrel product when requested.
• Audits all DPR's before scanning to make sure they are correct and accurate.
• Technical reading and often corrections for validations including IQ, OQ, PQ, control plans, PFMEA, OQ/PQ protocols.
• Other responsibilities may be assigned as required.

Qualifications

• High school diploma or equivalent
• Document Control Management systems experience preferred or developed specialized skills through job-related training and on-the-job experience
• Able to work with computer hardware and software applications including the internet and MS Office, including Word, Excel, and Outlook
• Professional and effective interpersonal skills
• Foster cooperative team-oriented relationships with all internal customers
• A familiarity with ISO regulations or demonstrated ability to rapidly develop an understanding of such regulations
• A high degree of attention to detail, thoroughness and follow-through
• Communication skills (both verbal and written)

Physical Demands

• Viewing a computer screen for extended period of time
• Ability to see to read fine print
• Must occasionally lift and/or move up to 25 pounds
• Occasional bending and stooping required
• Walking, standing and sitting for prolonged periods of time

Work Environment

Office and clean room environments.