With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.
We are seeking an experienced QC Contractor or Consultant to support the implementation and transition of laboratory electronic systems within a GMP Quality Control environment. This role will focus on the migration from existing Agilent OpenLab chromatography systems to Waters Empower, as well as the implementation and integration of a Laboratory Information Management System (LIMS).
This role requires strong hands-on technical, operational, and compliance support to ensure a smooth system transition, data integrity, and alignment with GMP regulatory requirements.
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Responsibilities
System Implementation & Migration
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Assist in configuration, setup, performing test runs, and verification of Empower system in alignment with GMP requirements.
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Support LIMS implementation, including workflow mapping, sample management, and data integration with CDS systems.
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Maintain a cGMP quality level of work for the QC operations to include training, documentation, demonstrated expertise in Agilent HPLC systems using OpenLab CDS, and extensive hands-on experience with Maurice Flex (Compass) for icIEF and CE SDS (required). Write and reviews data, technical reports, deviations, OOS investigations and test results and provide conclusions and proposals for future directions. Extensive hands-on experience with.
GMP Compliance & Data Integrity
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Ensure all activities comply with GMP, ALCOA+ principles, and data integrity regulations (FDA, EMA, ICH guidelines).
Method & Workflow Support
Training & Change Management
Cross-Functional Collaboration
Qualifications
Required Qualifications and Skills:
Preferred Skills & Experience:
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$40 - $60 an hour
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Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local Jaws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.