Representative - Data Steward QA

Role Summary

The Representative – QA (QA Data Steward) serves as a power user and data steward for IT systems supported by Quality Assurance. The Representative – QA (QA Data Steward) is responsible for improving business processes and supporting customer service interactions to ensure key business objectives are met. Representative – QA (QA Data Steward) represents Quality Assurance on projects, including six sigma. The Representative – QA (QA Data Steward) is responsible for activities that include change controls, non-conformance investigations, procedure revisions, impact assessment reviews, creation and revision of specifications, review and approval of cGMP documents, and maintaining regulatory compliance. Location: Indianapolis, LTC-S.

Responsibilities

• Power User for IT systems supported by QA.
• Maintain LIMS System Master Data.
• Quality Management Data Steward in SAP.
• Area Process Owner for IPM Specifications.
• Creates/Revises Documents, Such as Specifications, Resource Documents, and Procedures.
• Collaborate with Cross-Functional Partners, Such as Operations, TSMS, Engineering, Logistics and QC Labs, to Streamline Processes and Sustain Customer Service.
• Management of Regulatory Updates and Assesses Impact to Specifications and Flavor Management.
• Investigates Non-Conformances and Owns Change Controls to Support.
• Audit Support as Needed.

Qualifications

• Required: Proficiency with computer systems including LUNA, Darwin, PMX, SAP, TrackWise, Veeva and RIM.
• Required: Capable of Critical Decision Making while Maintaining a Strong Quality Mindset.
• Required: Demonstrated strong oral and written communication and interpersonal interaction skills.
• Required: Demonstrated strong technical writing skills.
• Required: Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
• Preferred: Experience as a power user or data steward for Darwin or SAP.
• Preferred: Six Sigma Green Belt Training/Experience.
• Preferred: Knowledge of operations business processes, such as batch disposition, materials management, laboratory specifications and methods.

Education

• Bachelor’s degree – Science or Engineering related degree preferred or equivalent work experience

Additional Requirements

• Overtime may be required.
• May be required to respond to operational issues outside of core business hours and days.
• Applicant may work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant.
• Mobility requirements and exposure to allergens should be considered when applying for this position.