QA MasterControl System Administrator

As the QA MasterControl System Administrator, you will be responsible for the effective configuration, operation, and maintenance of the MasterControl Electronic Document Management System (EDMS). You will act as a liaison between Quality and IT and ensure compliance of the MasterControl system with domestic and international regulations and internal processes. You will also follow standards and procedures to analyze data drawing conclusions, which can be readily obtained and make autonomous decisions appropriate to the system(s) being supported.

 

• Act as the main point-of-contact for MasterControl technical support

• Ensure effective configuration, administration, and maintenance of the system

• Test, document, and perform validation for system changes

• Perform timely investigations of issues within the system and recommend, implement, and document solutions

• Work with the supplier to resolve system issues; track and trend issues and communicate with impacted stakeholders

• Assist business process owners with technical issues related to module implementation and/or existing module configuration; support projects and initiatives from start through completion

• Manage user roles and access rights in the system

• Develop and execute the strategy for building and maintaining info cards, courses, workflows, vaults, and lifecycles

• Develop and maintain configuration and maintenance procedures for the system

• Proactively analyze regulatory, business, and customer requirements; propose and implement required improvements to MasterControl while maintaining compliance with internal processes

• Consults, collaborates, and partners with cross-functional stakeholders, subject matter experts, and business process owners on data for process enhancements.

• Perform ongoing evaluation of internal controls, analysis, and maintenance of documentation as it relates to supporting system improvements

• Build reports and analytics for users

• Generate trending data to support system effectiveness

• Participates in cGMP compliance inspections by the FDA, customers and/or other regulatory bodies

• Promote a safe, positive, and inclusive work environment

• Bachelor’s degree with 5+ years of experience with the administration and management of MasterControl or similar EDMS, in a medical device, pharmaceutical, or related highly regulated industry, or and equivalent combination of education and experience

• Expert level system administrator knowledge of MasterControl or similar EDMS

• Knowledge of FDA QSRs, ISO standards, and the MDD/MDR preferred

• Experience leading projects and process improvements

• Solid problem solving and decision-making skills

• Strong oral, written, and interpersonal communication skills

• High degree of accuracy and attention to detail

• Exercises judgment based on policies and management guidance to determine appropriate action

General office, laboratory, and cleanroom environments. Business travel from 5% - 25%. Potential exposure to blood-borne pathogens. Requires some lifting and moving of up to 25 pounds. The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods. Specific vision abilities required by this job include ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception.

Annual Base Salary Range:  $93,000 - $138,000    

We offer a competitive compensation package plus a benefits and equity program, when applicable.  

Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.  

 

 

·  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.

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.