QA Document Specialist I - Temp

Lever, Inc.; Alameda (CA); On-site; USD 80,231,000 - 100,289,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Life and AD&D insurance

401(k) with employer match

Paid parental leave

11 company holidays

Vacation time (min 15 days)

Paid sick time

Job summary

Penumbra, Inc. in Alameda, CA is seeking a QA Document Specialist II to support quality processes and regulatory compliance. You will process Engineering Change Orders, verify English usage and Penumbra formatting, and communicate with all levels to maintain document integrity.

The role requires a high school diploma or AA with 2+ years in regulated environments; a Bachelor's degree is preferred. Strong writing, attention to detail, and data-entry skills are essential.

Qualifications

• 2+ years of quality systems experience in regulated device or pharmaceutical environments.
• Bachelor's degree strongly preferred.
• Excellent and precise written and verbal communication and organizational skills.
• Experience with data entry.
• Knowledge of standard office software.
• Understanding of customer service.

Responsibilities

• Process Engineering Change Orders precisely and efficiently.
• Verify and correct English usage and Penumbra formatting in controlled documents.
• Communicate with all levels to maintain accuracy and integrity of Penumbra documentation.
• Maintain up-to-date paper and electronic file records.
• Assist in internal and external audits as backroom support.
• Assist in device history review and International Certificate of Compliance.
• Perform duties required by the Quality System.

Skills

Excellent written & verbal comms

Data entry

Attention to detail

Customer service understanding

Office software proficiency

Education

High school diploma or AA degree

Bachelor's degree preferred

Job description

As a QA Document Specialist II, you will play a pivotal role at Penumbra providing timely and accurate support of quality processes related to Document Services to ensure compliance with Penumbra procedures and regulatory requirements. Following standards and procedures and analyzing data, you will develop knowledge of Penumbra processes and external regulations to make independent decisions.

What You’ll Work On

• • Precisely and efficiently process Engineering Change Orders
• • Verify and correct English usage and Penumbra formatting in controlled documents. This includes, but is not limited to, correct spelling, punctuation, and accurate word usage
• • Communicate effectively with all levels of organization in processing Engineering Change Orders, maintaining the accuracy and integrity of all Penumbra controlled documentation
• • Maintain up-to-date paper and electronic file records
• • Assist in internal and external audits as key backroom support
• • Assist in other areas including device history review and International Certificate of Compliance
• • Performs duties required by the Quality System and other duties as assigned or requested

What You Contribute

• • A high school graduate or AA degree with 2+ years of quality systems experience in regulated device or pharmaceutical environments, or an equivalent combination of education and experience.
• • Bachelor's degree is strongly preferred
• • Excellent and precise written and verbal communication and organizational skills.
• • Knowledge of standard office software packages.
• • Experience with data entry.
• • Excellent attention to detail.
• • Understanding of customer service.

Working Conditions

General office, production, laboratories, and controlled environment facility. 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 communicate and exchange accurate information with Penumbra employees at all levels on a daily basis.

Base Pay Range Per Hour: $28.00 – 35.00 / hour

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

What We Offer

• • 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 toPenumbra's Privacy Notice for California Residents.

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