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QUALITY CONSULTING GROUP, a leader inthe pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.Responsibilities:
Routinely perform complex electronic data entry according to Standard Operating Procedure (SOP).
Creation and validation of electronic batch records (EBR) per procedures using Manufacturing Execution System (MES) and ERP.
Support paper on glass manufacturing batch record process.
Translation and understanding of process specifications established by development teams into source documents (paper or electronic) utilized by production teams.
Creation of Parameter Value Lists in EBR
Editing and creation of GMBRs in EBR
Translation of instruction from paper sources to electronic systems
Internal support operations (eg, data verification, document management, SOP revisions)
Manufacturing support focused on Electronic Batch Record (EBR) generation, editing, real-time troubleshooting and managing the EBR validation for new or modified processes.
Assisting in the implementation of new MES functionality.
Participate and contributing to projects to introducing new products and/or advancement of new manufacturing technologies into the plant.
Communicate with manufacturing, PD, supply chain, QA
Qualifications:
Bachelor's degree in engineeringor Biological Sciences
2+ years of drug product/manufacturing experience.
Previous biopharmaceutical manufacturing experience.
Significant experience with PAS X, Werum software for electronic batch records with some understanding of editing and validation.
Able to Revise/Create PVLs, GMBRs, ESPs
Ability to provide troubleshooting support
Provide assessments for projects and NPIs
Remote (Pacific time zone preferred or can maintain pacific hours.)
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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