Production Documentation Specialist

About the role

Responsible for 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.

Responsibilities

• Receives and reviews production requests and assists in production control
• Take primary responsibility of printing Production DHRs and verifying accuracy in QAD
• Review completed Device History Records with complete accuracy and attention to detail
• Assist Production personnel with follow up on DHR discrepancies and Material Investigations
• Provide lot status reports/updates during Master Schedule meetings
• Accurately reconcile the finished and rejected parts
• Verify training on Device History Records
• Work closely with multiple backend teams to assist in expediting Device History Records to make sterile load dates
• Communicate effectively with supervisors to correct any errors or omissions in Device History Records or associated documents
• Accurately enter Device History Record information into database
• Scan, label and file Device History Records correctly
• Assist in various other Production Specialist tasks as needed
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures
• Ensure other members of the department follow the QMS and regulations

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

Working Conditions

General office, production, and controlled environments. The employee is frequently required to stand, walk, and reach with hands and arms, to use a computer and sit for extended periods of time, and occasionally to stoop, kneel, crouch, bend or crawl. Specific vision abilities required by this job include ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception.

Pay

Starting base pay is $20.00 - $28.00 per hour. Individual compensation will vary over time based on factors such as performance, skill level, competencies, work location, and shift.

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)