Production Documentation Specialist

Penumbra • Salt Lake City, UT

22h • Onsite

About The Position

The Production Documentation Specialist is responsible for the timely and accurate printing, review, and issuance of Device History Records, ensuring compliance with Penumbra procedures and regulatory requirements. The Production Documentation Specialist will develop a working knowledge of applicable domestic and international regulations as well as expertise in internal procedures and reporting systems.

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)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree