Production Documentation Specialist I

The Production Documentation Specialist 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.

· Receives and reviews production requests and assists in production control

· Take primary responsibility of printing Production DHRs and verifying accuracy in ERP System/ SAP*

· Review completed Device History Records with complete

· Accurately reconcile the finished and rejected parts

· Able to work 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

· 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.

· Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. * 

· Ensure other members of the department follow the QMS, regulations, standards, and procedures. *

· Regular, reliable attendance onsite*

· Perform other work-related duties as assigned.

· High School diploma or Associate degree with 1 + years of production systems experience in regulated device or pharmaceutical environments, or equivalent combination of education and experience

· Good written/verbal communication and organizational skills required

· Great attention to detail

· Proficiency with MS Word, Excel, and Power Point

• General office, production, and controlled environments 

• Willingness and ability to work on site.

• Potential exposure to blood-borne pathogens

• Requires some lifting and moving of up to 25 pounds

• Must be able to move between buildings and floors.

• Must be able to remain stationary and use a computer or other standard office 

equipment, such as a printer or copy machine, for an extensive period of time each day.

• Must be able to read, prepare emails, and produce documents and spreadsheets. 

• Must be able to move within the office and access file cabinets or supplies, as needed.

• Must be able to remain stationary and use a microscope, cleanroom or laboratory 

equipment, or other standard office equipment, for an extensive period of time each 

day. Will need to use a computer for email, trainings, procedures, etc. 

• Must be able to communicate and exchange accurate information with employees at all 

levels on a daily basis

Starting Base Pay is $20.00- $28.00/ hour       

Individual compensation will vary over time based on factors such as performance, skill level, competencies, work location and shift.

•A collaborative teamwork environment where learning is constant, and performance is rewarded.

•The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.

•A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).

 

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.

 

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.

 

If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.

 

For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.