Quality Ops Analyst 1

Planet Pharma; San Diego (CA); On-site; USD 42,000 - 52,000; Full time

Job summary

Planet Pharma is seeking a Quality Data Management professional to govern master data across SAP, Teamcenter, MES, and LIMS, ensuring accuracy and compliance throughout the product lifecycle. The role supports NCRs, CAPAs, deviations, and change controls, with responsibilities spanning QM data governance, data remediation, and end-to-end QN lifecycle management.

Responsibilities include material master updates, serialization, data verification, and troubleshooting SAP QM and Teamcenter issues.

Responsibilities

• Quality data governance across SAP, Teamcenter, MES, and LIMS.
• Ensure data accuracy, integrity and compliance with procedures.
• Manage quality data updates to support product lifecycle activities.
• Support NCRs, CAPAs, deviations, acceptance activities and change controls.
• Perform data quality remediations and validations.
• Material master updates, inspection planning maintenance, shelf-life and batch attribute updates.
• Serialization and product configuration support.
• Data verification and correction activities.
• End-to-end QN lifecycle support (NCRs, RMAs, RTVs) and investigation handling.
• System transactions for containment and disposition activities.
• Troubleshoot SAP QM/Teamcenter issues impacting quality operations.
• QM master data governance and execution—global.
• Teamcenter & PLM: quality activities and lifecycle changes.
• Post-implementation quality system updates.
• Non-standard quality activities management with proper documentation.

Job description

Target PR Range:30.25-38.00/hr DOE

Core Responsibilities

1. Quality System Data Management

Responsibilities

• Maintain and govern quality-related master data across SAP, Teamcenter, and connected systems (MES, LIMS)
• Ensure data accuracy, integrity, and compliance with established procedures.
• Manage quality data updates required to support product lifecycle activities.
• Support data corrections resulting from quality records such as NCRs, CAPAs, deviations, acceptance activities and change controls.
• Perform data quality remediations and validations.

Key Activities

• Material master updates
• Inspection planning maintenance
• Shelf-life and batch attribute updates
• Serialization and product configuration support
• Data verification and correction activities

2. Quality Notifications (QNs such as NCRs, RMAs,RTV) Support

Responsibilities

• Establishing requirements and management of end to end QN lifecycle (initiate to complete)
• Provide system and transactional support for NCRs, RMAs, RTVs and investigation activities.
• Execute quality system transactions required to support containment and disposition activities.
• Troubleshoot system-related issues impacting QN processing.
• Support implementation of corrective actions through data and system updates.

Key Activities

• Global containment & disposition support
• Containment Strategy - ensuring requirements are around control of material are met and supporting documents are gathered.
• NCR troubleshooting, master data support from the back end of SAP ECC processing
• PIS creation and maintenance, Child NCR creation
• Ensuring accurate NCR disposition requirements are met
• Site-to-site transfer support, pre-disposition tasks
• Investigation and QN support related to QM data and/or containment & disposition

3. SAP Quality Management (QM) Support

Responsibilities

• Serve as the primary operational support team for SAP QM-related activities.
• Resolve SAP transactional issues affecting quality operations.
• Maintain inspection and batch management configurations.
• Support execution and closure of inspection-related activities.
• QM Master Data Governance and Execution - Global

Key Activities

• Inspection lot troubleshooting
• Usage decision support
• MIC creation and maintenance
• Inspection plan maintenance
• Batch master corrections
• Quality inspection processing
• RMA inspection lot processing
• Queue clearance and synchronization activities

4. Teamcenter & Product Lifecycle Support

Responsibilities

• Support product lifecycle quality activities through Teamcenter transactions and approvals.
• Ensure proper execution of quality-related lifecycle changes.
• Coordinate post-implementation quality system updates.

Key Activities

• Material promotions from development to pre-production to production
• EOL assessments and document obsolescence
• Plant extensions
• Inspection activation/deactivation
• Development inventory disposition
• Data steward approvals
• Post-implementation updates

5. Extended Quality Process Support

Responsibilities

• Manage non-standard quality activities that require system expertise and operational execution.
• Ensure all activities are appropriately documented and compliant with procedures.

Key Activities

• Date extension processing
• Material adjustments
• Offline inventory transactions
• Regrade/reclass activities
• Recharge/recalibration support
• External vendor rework support