Recipe Author Job at Scorpion Therapeutics in Lansing

Responsibilities

Design, prepare, and revise Electronic Batch Records (EBR).
Support end users with EBR execution and usage.
Manage EBR design/configuration changes, process reviews, and alignment with continuity-plan documentation.
Initiate and own change controls for documents and equipment; ensure timely closure and implementation.
Participate in process mapping; engage SMEs, leads, and operators to ensure critical parameters are captured.
Serve as sustainment point of contact for electronic batch record manufacturing issues;
Execute functional verification protocols for MES/recipe design and baseline configuration.
Support continuous improvement and applicable batch record changes.
Follow up on BT tickets and ensure resolution of EBR issues.
Ensure activities comply with procedures; identify deviations/exceptions and escal
Adhere to safety procedure and GMP/GDP practices.
Reassess/participate in agile change environment to drive continuous improvement; support projects/deployments.
Participate in cross-functional teams to support, enhance, and upgrade AMPS.
Assist with controlling/tracking periodic EBR procedure updates and manage emergency changes.
Attend scheduled training and provide cross-training across AMPs areas.
Qualifications/Requirements

Bachelor’s (0+ years) OR Associate’s (4 years) OR High school diploma (6 years) in relevant field.
Pharmaceutical experience.
Certifications: M1, Yellow Belt and/or Pfizer Human Performance methodology.
Computer skills: HTML, Java, or object-oriented programming.
Focused in systems analyst/data management.
EBR/MES build experience.
Experience working in Quality Tracking Systems.
Application

Authorize to work in the U.S. (visa sponsorship not available for this role).

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