Jobs via Dice
Empower CDS administration / support
Jobs via Dice, Greenfield, Indiana, United States, 46140
Job Title
Empower CDS Administration / Support
Location
Greenfield, IN
Employment Type
Full-time Contract
Educational Qualification
Bachelor's Degree
Experience Range
8-10 years
Key Responsibilities
Manage user accounts, access rights, roles, and privileges in Empower CDS. Perform system configuration, project management, and template/report customization. Provide L2/L3 support for Empower users in QC/analytical labs. Integrate lab instruments (HPLC/UPLC/Dissolution/UV) with Empower and troubleshoot connectivity and data acquisition. Support CSV activities for Empower and integrated lab systems; develop and maintain validation documentation (URS, FS, DS, IQ/OQ/PQ, Test Scripts, Traceability Matrix). Ensure compliance with GxP, 21 CFR Part 11, Annex 11, internal SOPs; participate in audits and inspections. Maintain audit trails, backup, archival, and disaster recovery procedures; conduct periodic system reviews. Collaborate with QA, IT, and Lab teams on change control and deviations. Train and mentor lab users on Empower functionalities and best practices; propose process improvements for data integrity, system efficiency, and compliance.
Required Qualifications
3+ years experience administering and supporting Empower CDS. 3+ years experience integrating and troubleshooting HPLC/UPLC and other analytical instruments. 3+ years experience in CSV and preparation of validation deliverables. 1+ year experience with GxP, 21 CFR Part 11, Annex 11, ALCOA+ principles, and data integrity requirements.
Soft Skills
Excellent communication skills; verbal and written. Strong interpersonal skills; build productive relationships. Analytical mindset; problem solving and troubleshooting. Team player; proactive, diligent, and timely updates.
EEO Statement
At WinWire Technologies, all qualified applicants receive equal consideration for employment; we are an Equal Opportunity Employer.
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Empower CDS Administration / Support
Location
Greenfield, IN
Employment Type
Full-time Contract
Educational Qualification
Bachelor's Degree
Experience Range
8-10 years
Key Responsibilities
Manage user accounts, access rights, roles, and privileges in Empower CDS. Perform system configuration, project management, and template/report customization. Provide L2/L3 support for Empower users in QC/analytical labs. Integrate lab instruments (HPLC/UPLC/Dissolution/UV) with Empower and troubleshoot connectivity and data acquisition. Support CSV activities for Empower and integrated lab systems; develop and maintain validation documentation (URS, FS, DS, IQ/OQ/PQ, Test Scripts, Traceability Matrix). Ensure compliance with GxP, 21 CFR Part 11, Annex 11, internal SOPs; participate in audits and inspections. Maintain audit trails, backup, archival, and disaster recovery procedures; conduct periodic system reviews. Collaborate with QA, IT, and Lab teams on change control and deviations. Train and mentor lab users on Empower functionalities and best practices; propose process improvements for data integrity, system efficiency, and compliance.
Required Qualifications
3+ years experience administering and supporting Empower CDS. 3+ years experience integrating and troubleshooting HPLC/UPLC and other analytical instruments. 3+ years experience in CSV and preparation of validation deliverables. 1+ year experience with GxP, 21 CFR Part 11, Annex 11, ALCOA+ principles, and data integrity requirements.
Soft Skills
Excellent communication skills; verbal and written. Strong interpersonal skills; build productive relationships. Analytical mindset; problem solving and troubleshooting. Team player; proactive, diligent, and timely updates.
EEO Statement
At WinWire Technologies, all qualified applicants receive equal consideration for employment; we are an Equal Opportunity Employer.
#J-18808-Ljbffr