Production Documentation Specialist

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 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, reg

 

 

· 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

 

 

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.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

 

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, 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.