QC Consultant (Empower & LIMS Specialist)
About The Position
With extensive experience in developing biologics and bioconjugates, Abzena offers a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, they find the best solution and use the right technologies to design, develop and manufacture products to ensure vital medicines reach patients quickly and safely. Abzena is dedicated to quality excellence and driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. Abzena is more than a CDMO, they are a responsible and dedicated partner that takes care of products from concept to patient. Abzena is 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.
Requirements
- Bachelor’s degree in chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific field.
- 3–7+ years of experience in GMP Quality Control laboratory environment.
- Hands-on experience with HPLC/UPLC systems and chromatography data systems.
- Strong understanding of GMP regulations and data integrity expectations.
- Extensive hands-on experience with Maurice Flex (Compass) for icIEF and CE SDS (required).
Nice To Haves
- Direct experience with either Empower CDS or LIMS implementation preferred.
- Prior experience transitioning from OpenLab, ChemStation, or similar CDS to Empower.
- Exposure to LIMS configuration or implementation projects.
- Experience supporting CSV (Computer System Validation) activities.
- Strong problem-solving and troubleshooting skills in analytical environments.
- Ability to work independently in a fast-paced project environment.
Responsibilities
- Support migration of analytical methods, data, and workflows from Agilent OpenLab to Waters Empower.
- Assist in configuration, setup, performing test runs, and verification of Empower system in alignment with GMP requirements.
- Support LIMS implementation, including workflow mapping, sample management, and data integration with CDS systems.
- Participate in system validation activities including User Requirements Specifications (URS), Functional Specifications (FS), and Installation/Operational/Performance Qualification (IQ/OQ/PQ).
- 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.
- Initiate quality records as needed and perform technical writing of SOPs and protocols associated with electronic migration process and investigations.
- Supports audit preparations.
- Ensure all activities comply with GMP, ALCOA+ principles, and data integrity regulations (FDA, EMA, ICH guidelines).
- Review and support validation documentation, test scripts, and execution records.
- Identify and escalate compliance risks during system transition.
- Assist in transfer and verification of HPLC and CE (Maurice) /analytical methods into Empower.
- Support QC analysts in troubleshooting system-related issues during transition.
- Collaborate with analytical development (AMD) and QC teams to ensure method readiness in new systems.
- Provide training and user support for Empower CDS and LIMS to QC analysts and stakeholders.
- Develop or support creation of SOPs, work instructions, protocols, and system user guides.
- Facilitate user adoption and minimize disruption during transition.
- Work closely with QC, QA, IT, and external vendors during system implementation.
- Participate in project meetings, status updates, and risk assessments.
- Support audit readiness activities related to system implementation.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
