Change Management Jobs in Holly Springs (NC)
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Search Results - Change Management Jobs in Holly Springs (NC)
Holly Springs (NC)
requests, validate configurations, provide user support and troubleshoot as needed. This role is responsible to implement approved configuration changes within the LIMS platform as outlined in controlled change management records.
The position...
icims.com -
Holly Springs (NC)
for project deliverables in accordance with the governing processes, and procedures within the assigned Quality area
• Assesses the impact of system controls and process modifications and maintains oversight of change management processes
• Provides Quality...
icims.com -
Holly Springs (NC)
of change management processes to ensure laboratory Systems are first validated, and then maintained in a validated state through site startup and into commercial operations.
• Provide oversight and approval of laboratory system and process lifecycle...
icims.com -
Holly Springs (NC)
QA oversight and support of project deliverables in accordance with governing processes, and procedures for the DT program.
• Assess the impact of system and process modifications and maintain oversight of change management processes to ensure...
icims.com -
Holly Springs (NC)
in the development of QC team members.
What You’ll Do
• • Ensures GMP compliant laboratory operations according to guidelines
• Manages the daily activities of the QC Raw material team and assuring dedicated focus on testing, release, change management and Tech...
icims.com -
Holly Springs (NC)
Authors, reviews, and approves SOPs, protocols, reports, change management reports, Trackwise deviations and investigations for the QC Bioassay/Virology team as needed
• Ensures department is ready for customer visits, audits and regulatory inspections...
icims.com -
Holly Springs (NC)
and creation of associated documentation for tech transfer, changeover, preventive maintenance plans (PMs), and column packing
• Supports change management records, investigations, corrective and preventive actions (CAPAs) and continuous improvement (CI)...
icims.com -
Holly Springs (NC)
and/or internal sample chain of custody forms or logbooks
• Collaborates cross-functionally to address sample issues that arise from manufacturing, laboratories, or the warehouse
• Assists in authoring and reviewing SOPs, protocols, reports, change management...
icims.com -
Holly Springs (NC)
and change management
• Ensures overall performance of QC Chemistry team according to KPIs - assuring turn-around-times of all testing and supporting drug substance and drug product manufacturing production.
• Oversees and manages laboratory exceptions...
icims.com -
Holly Springs (NC)
and qualification efforts
• Support trouble shooting including acting as a process subject matter expert (SME) for their process respective area(s)
• Coordinate Batch Planning including process template creation, import and management of preventative maintenance...
icims.com -
Holly Springs (NC)
of associated documentation for changeover, PMs, column packing
• Supports tech transfer
• Initiates or supports change management records, investigations, corrective and preventive actions (CAPAs), and continuous improvement (CI) activities
• Identifies...
icims.com -
Holly Springs (NC)
factory acceptance testing (FAT) and site acceptance testing (SAT), as required
• Actively participate in establishment of batch handling processes for Drug product manufacturing
• Execute and drive minor projects and initiate change management requests...
icims.com -
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