Data Governance Analyst

Posting Date 1 year ago(8/5/2020 8:42 PM)
Requisition ID
2020-7248
Job Location(s)
Pittsburgh PA United States
Travel
Less than 10%
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Information Technology

Overview

Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.

 

The Data Governance Analyst at Cook MyoSite will be a liaison between the technical team, quality departments, and process owners. For data integrity and data privacy related to computer systems, the Data Governance Analyst has responsibility for ensuring system/process owners accountability to meet compliance objectives for data integrity. The site data integrity program consists of policies and procedures designed to drive compliance to applicable regulatory standards, corporate standards, and best practices in the areas of data governance and data privacy. To support the Data Integrity program, the CSV Data Governance Analyst will participate in change management, computer system validation activities, and general data governance support for the department.

Responsibilities

• Developing and continually improving data integrity policies, procedures, and vocabulary including:
   o identification of assets, data, and meta-data, and process ownership
   o data mapping the chain of custody, system of reference, and any secondary references
   o identifying data lifecycles with the associated systems
   o maintaining a data resource inventory
• Audit systems and providers for data integrity, data privacy, and data governance compliance
• Responsible for authoring and execution of data migration plans and protocols
• Initiate, coordinate, and execute projects to ensure the successful completion of CSV activities
• Promote and educate business units about data integrity for computerized systems
• Work closely with business unit leadership to continuously improve the use of strategic information assets
• Author/maintain policy and procedure documents for data integrity compliance
• Practice and stay current with ISPE GAMP best practices, biologics regulations, Parenteral Drug Association (PDA), United States Pharmacopeia (USP), and applicable ISO standards
• Maintain professional and technical knowledge by attending educational workshops; benchmarking state-of-the-art practices; participating in professional societies
• Maintain frequent communication with Information Services, process and system owners, and other support functions

Qualifications

• Undergraduate degree in Computer Science, Information Science, IT, Bio Engineering, or any related field or 6 years direct, relevant experience in IT (Computer Systems) validation to provide a comparable background

• Minimum of 3-6 years’ as a project or technical lead is preferred

• 3+ years of formal auditing or testing of computer systems and infrastructure is preferred

• Experience working in a regulated environment is preferred

• Proficient knowledge of Microsoft Office software, and other general office equipment

• In-depth understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical manufacturing and best practices (e.g. ISPE GAMP)

• Up-to-date with changes in technology and the business implications/applications of new technologies

• Ability to learn and support new systems and applications, and the ability to provide technical training to end users

• Ability to demonstrate strong knowledge of data governance best practices 

• Ability to demonstrate exceptional analytical and conceptual thinking skills

• Experience in resolving issues of data quality, storage, protection and dissemination 

• Demonstrable ability to influence stakeholders and work closely with them to determine acceptable solutions

• Ability to demonstrate problem-solving skills and ability to work in both collaborative and independent work situations

• Ability to demonstrate sound knowledge of privacy standards and associated regulatory requirements is preferred

 

 

Physical Requirements:

• Setting (Remote/Field Based): When working remotely, the expectation for the employee's travel time to our Pittsburgh, PA site should be typically less than 5-6 hours, with the maximum being 24 hours. This travel will support on-site situations such as operational emergencies, physical testing/configuration of systems/equipment, or the occasional training

• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required

• Ability to work under specific time constraints

• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time

• Visual and manual acuity for working with computers and equipment

• Ability to conduct and hear ordinary conversation and telephone communication

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