Senior Data Validation Specialist
Posting Date 3 days ago (7/22/2022 10:01 PM)
Requisition ID 2022-11197 Job Location(s) Pittsburgh PA United States Travel None 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 Senior Data Validation Specialist at Cook MyoSite Inc. is a critical team member of the Computer System Validations (CSV) department and will be a liaison between the technical team, quality departments, and process owners.
To support the Data Integrity program, the CSV Data Governance Analyst will participate in general data governance management (e.g., procedure development and auditing), change management, and computerized system data validation activities. The goal of this participation, to deliver and maintain data integrity in Cook MyoSite computerized systems.
This is a remote role with occasional travel to Pittsburgh, PA for on-site support.
Responsibilities
Responsible for developing and continually improving the company's data integrity processes and procedures, especially those related to validation of computerized systems.
Data mapping the data chain of custody, system of reference, and any secondary references for computerized systems.
Identifying the data lifecycle with the associated computerized systems.
On a continuous basis, audit for data integrity, data privacy, and data governance compliance the following:
o On-premises computerized systems and infrastructure.
o SaaS, PaaS, and IaaS providers, hosted systems, and cloud computing.
o CROs and outsourced clinical sites.
Responsible for planning and executing data migration and verification activities including authoring, and execution of CSV protocols.
Maintain frequent communication with IT, Computer System Applications, Quality Assurance, and Process Owners.
Collaborating with the MyoSite Operational Excellence Office to ensure process mapping and data mapping are aligned.
Must maintain company quality and safety standards.
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.
Qualifications
Undergraduate degree in Computer Science, Information Science, IT, Bio Engineering, or any related field or 10 years direct, relevant experience in IT (Computer Systems) and validation to provide a comparable background.
Minimum of 7+ years working in the biologics, pharma, or medical device industries.
Minimum of 3+ years documenting data lifecycles including:
o Identifying the data lifecycle in computerized systems.
o Data mapping the data chain of custody, system of reference, and any secondary references for computerized systems.
Minimum of 3+ years authoring test scripts or validation protocols for data migration.
Minimum of 3+ years executing test scripts or validation protocols.
Ability to demonstrate strong knowledge of data governance best practices.
Ability to demonstrate strong knowledge of privacy standards and associated regulatory requirements.
Ability to demonstrate understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical manufacturing and best practices (e.g. ISPE GAMP).
Ability to demonstrate problem-solving skills and ability to work in both collaborative and independent work situations.
Ability to demonstrate exceptional analytical and conceptual thinking skills.
Proficient knowledge of Microsoft Office, Teams, and SharePoint.
Physical Requirements:
Setting (Remote): 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.
Ability to conduct and hear ordinary conversation and telephone communication.
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.
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"We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class."
Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.
