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About the Role

This role is responsible for managing controlled documentation to ensure compliance with operational, corporate, and regulatory requirements, providing effective documentation and records management, and coordinating document reviews.

Responsibilities

Identify and manage all controlled documentation to ensure compliance with operational, corporate, and regulatory requirements.
Provide effective and efficient documentation and records management.
Coordinate the scheduling of formal document reviews for site documentation.
Maintain file system of current drawing revisions and documents of external origins.
Communicate changes to document control procedures or other relevant information.
Dispose of or destroy records and documents securely and properly 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 the 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.
Read and interpret 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.
Audit all DPR's before scanning to ensure they are correct and accurate.
Discuss necessary corrections or updates with Quality Technicians and crew leads.
Perform technical reading and corrections for validations including IQ, OQ, PQ, control plans, PFMEA, OQ/PQ protocols.
Perform other responsibilities as assigned.

Requirements

High school diploma or equivalent.
Able to work with computer hardware and software applications including the internet and MS Office, including Word, Excel, and Outlook.
Foster cooperative team-oriented relationships with all internal customers.
A high degree of attention to detail, thoroughness, and follow-through.

Skills

Document Control Management systems experience preferred.
Developed specialized skills through job-related training and on-the-job experience.
Professional and effective interpersonal skills.
Familiarity with ISO regulations or demonstrated ability to rapidly develop an understanding of such regulations.
Communication skills (both verbal and written).

Location

Glens Falls, NY 12801

Work Type

Full Time
Office
Clean room

Education Level

High school diploma or equivalent

Salary/Compensations

$25.00 - $28.00 Hourly