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Organization Overview:The Quality Assurance Organization unit is responsible for the compliance oversight of the manufacturing operations. This position is an Associate - Quality Assurance to support MES activities.Responsibilities:•This role will be working specifically with activities related to electronic batch records.•Active participation in team meetings to provide input on project timeline considerations, activities, escalations and status of assigned tasks.•Evaluate paper batch record and instructions to align it with electronic batch record requirements.•Review operational processes and how they translate into electronic batch records.•Serve and support the recipe authors for batch record construction and suggest path forward.•Revise and approve configuration documents.•Participate in the revision of the flow charts of the electronic batch record objects related to the manufacturing stages and steps.•Review of all PMX objects related to an electronic ticket.•Participate on objects verification on system, including issuance of summary of changes to ease the revision process.•Review documentation associated to PMX production procedures (Core documents and their Attachments - Visio, Master Data, EQM, Choice list, History of changes.•Evaluation of Stabilization forms that may arise after transitioning from paper batch records to electronic batch records.•Approve SOPs related to electronic batch record changes or new implementations.•Familiarize with PMX Objects update tracker to be used for transitioning activities.•Perform Informal testing and formal testing stages.•Execute Test Scripts and Test Scripts Data Sheet.•Execute Formal Testing in the Application Lifecycle Management (or similar platform) and assist in resolution of defects generation if any.•Revise Test Summary Report.•Participate in objects transitioning activities and transition objects as needed. •Ensure compliance with Data Integrity aspects.Basic Requirements: This is a contract-based position.•Bachelor’s degree or higher in science or engineering•5+ years of experience in GMP operations; at least 3 years in Quality•Understanding and working knowledge of domestic and international data integrity regulations and other policies/regulations, as applicable.•Understanding of IT systems design, controls, and usage.•Knowledge and experience working with electronic batch record systems (e.g., Syncade, PMX)Additional Skills/Preferences:•Bilingual (English/Spanish)•Strong customer service skills and teamwork oriented•Strong compliance mindset and sound judgment•Ability to communicate effectively with all levels and functions in the organization.•Ability to work on multiple concurrent project initiatives•Availability to work irregular hours, on weekends and after regular working hours if required•Ability to take initiative, to be assertive, to lead by example and to build high-quality relationships.•Highly flexible, adapting to changes in priorities, requirements and processes is required.