ARx Information Technology Compliance Officer
2.
9 Quick Apply Full-time 6 hours ago Full Job Description Job Summary The Information Technology Compliance Officer will manage deployment of laboratory, manufacturing and research devices/systems on the ARx IT infrastructure; ensure the successful completion of building, testing, compliance and deployment tasks within the ARx infrastructure environments.
Develop and execute protocols and test scripts for data acquisition systems, identify gaps, and consult on and direct plans for resolution.
This person is responsible for writing GxP computer validation protocols and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports.
This person will be the data integrity steward and is responsible for operational coordination and implementation of processes necessary to ensure data integrity, data management and data security.
The Information Technology Compliance Officer mission will be to contribute to the governance, quality and integrity of the data and metadata managed with the computer systems throughout their life cycle.
CW1
Essential Functions:
Manage deployment of laboratory, manufacturing, and research devices on the ARx IT infrastructure.
Analyze and document requirements in detail and design the best fit system or modifying existing systems, User Requirement Specifications, Support Functional Specification, and Design creation for new and existing Computer Systems.
Document and support Installation/Operation qualification for data acquisition systems Contribute to the application of ARx governance on data integrity to control and minimize risks to data integrity for data acquisition systems.
Develop action plans to remediate failures associated with the principles of data integrity.
If applicable, verify that the backup/restore and archiving processes are operational.
Maintain the list of rights assigned per user.
Ensure that people accessing the computer systems have the appropriate training and authorizations.
Participate in thethe maintenance of the validated state of the computer systems and conduct verification protocols when needed.
Conduct internal audits related to data integrity.
Ensure periodic reviews are conducted and updated as necessary.
Participate in audit trail reviews.
Participate in impact studies and risk analyses when evaluating and updating computer software systems or changing processes.
Utilize the ARx change management program to appropriately assess change.
Test applications and interface changes before setting up users for testing.
Support supplier qualifications of cloud based providers.
Drive to solutions while promoting IT in partnership with QA to establish quality culture as it relates to computerized systems.
Work with the Quality department educating system owners on their responsibilities.
Act as the Administrator to laboratory, manufacturing and research Computer systems Additional
Responsibilities:
Executes other special projects as assigned by the Director of Quality.
Job Specifications:
BS in a Computer Science or Engineering field or equivalent experience Minimum 3-5 years' experience with Computer systems validation in the USA Minimum 3-5 years' experience working in a GMP environment Experience in Data Integrity with GAMP and 483, compliance, deep 21CFR Part 11 experience is highly desired Experience in biotech and pharma is preferred over medical device Experience with FactoryTalk, Siemens and their associated platforms, Rockwell and associated platforms, Xenon, Waters Empower, Systech serialization systems, Oracle EBS, LIMS and QMS systems.
Has exceptional written and verbal communication skills.
Can exercise strong problem-solving skills and analytical thinking.
CW1 What are your trying to say in this area? Quick Apply.
Estimated Salary: $20 to $28 per hour based on qualifications.
9 Quick Apply Full-time 6 hours ago Full Job Description Job Summary The Information Technology Compliance Officer will manage deployment of laboratory, manufacturing and research devices/systems on the ARx IT infrastructure; ensure the successful completion of building, testing, compliance and deployment tasks within the ARx infrastructure environments.
Develop and execute protocols and test scripts for data acquisition systems, identify gaps, and consult on and direct plans for resolution.
This person is responsible for writing GxP computer validation protocols and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports.
This person will be the data integrity steward and is responsible for operational coordination and implementation of processes necessary to ensure data integrity, data management and data security.
The Information Technology Compliance Officer mission will be to contribute to the governance, quality and integrity of the data and metadata managed with the computer systems throughout their life cycle.
CW1
Essential Functions:
Manage deployment of laboratory, manufacturing, and research devices on the ARx IT infrastructure.
Analyze and document requirements in detail and design the best fit system or modifying existing systems, User Requirement Specifications, Support Functional Specification, and Design creation for new and existing Computer Systems.
Document and support Installation/Operation qualification for data acquisition systems Contribute to the application of ARx governance on data integrity to control and minimize risks to data integrity for data acquisition systems.
Develop action plans to remediate failures associated with the principles of data integrity.
If applicable, verify that the backup/restore and archiving processes are operational.
Maintain the list of rights assigned per user.
Ensure that people accessing the computer systems have the appropriate training and authorizations.
Participate in thethe maintenance of the validated state of the computer systems and conduct verification protocols when needed.
Conduct internal audits related to data integrity.
Ensure periodic reviews are conducted and updated as necessary.
Participate in audit trail reviews.
Participate in impact studies and risk analyses when evaluating and updating computer software systems or changing processes.
Utilize the ARx change management program to appropriately assess change.
Test applications and interface changes before setting up users for testing.
Support supplier qualifications of cloud based providers.
Drive to solutions while promoting IT in partnership with QA to establish quality culture as it relates to computerized systems.
Work with the Quality department educating system owners on their responsibilities.
Act as the Administrator to laboratory, manufacturing and research Computer systems Additional
Responsibilities:
Executes other special projects as assigned by the Director of Quality.
Job Specifications:
BS in a Computer Science or Engineering field or equivalent experience Minimum 3-5 years' experience with Computer systems validation in the USA Minimum 3-5 years' experience working in a GMP environment Experience in Data Integrity with GAMP and 483, compliance, deep 21CFR Part 11 experience is highly desired Experience in biotech and pharma is preferred over medical device Experience with FactoryTalk, Siemens and their associated platforms, Rockwell and associated platforms, Xenon, Waters Empower, Systech serialization systems, Oracle EBS, LIMS and QMS systems.
Has exceptional written and verbal communication skills.
Can exercise strong problem-solving skills and analytical thinking.
CW1 What are your trying to say in this area? Quick Apply.
Estimated Salary: $20 to $28 per hour based on qualifications.
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