Documentation Specialist Jobs

About The Position

Requirements

• High School diploma or Associate degree with a minimum of 1 to 3 years of production systems experience in regulated device or pharmaceutical environments, or equivalent combination of education and experience
• Strong written/verbal communication and organizational skills required

Responsibilities

• Receives and reviews production requests and assists in production control
• Takes primary responsibility for printing Production DHRs and verifying accuracy in QAD
• Reviews completed Device History Records with complete accuracy and attention to detail
• Assists Production personnel with follow-up on DHR discrepancies and Material Investigations
• Provides lot status reports/updates during Master Schedule meetings
• Accurately reconciles the finished and rejected parts
• Verifies training on Device History Records
• Works closely with multiple backend teams to assist in expediting Device History Records to make sterile load dates
• Communicates effectively with supervisors to correct any errors or omissions in Device History Records or associated documents
• Accurately enters Device History Record information into database
• Scans, labels and files Device History Records correctly
• Assists in various other Production Specialist tasks as needed
• Adheres to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
• Ensures other members of the department follow the QMS

Benefits

• medical
• dental
• vision
• life
• AD&D
• short and long-term disability insurance
• 401(k) with employer match
• paid parental leave
• eleven paid company holidays per year
• a minimum of fifteen days of accrued vacation per year, which increases with tenure
• paid sick time in compliance with applicable law(s)