Overview
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.
The Quality Control (QC) Associate I / II is responsible for performing analytical testing and laboratory activities that support stability, qualification/validation, and supporting release testing of biologics in a cGMP-regulated environment. This role supports routine QC operations through the execution of analytical methods, data review, laboratory investigations, method transfer activities, equipment maintenance, and continuous improvement initiatives while ensuring compliance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and applicable regulatory requirements.The successful candidate will demonstrate strong technical expertise, attention to detail, data integrity awareness, and a commitment to maintaining inspection readiness while supporting internal and client-driven programs.
Responsibilities
Analytical Testing and Laboratory Operations
- Perform routine and non-routine analytical testing of in-process, release, stability, characterization, reference standard, raw material, and investigational samples using approved methods and procedures.
- Execute a variety of analytical techniques commonly used for biologics and large-molecule products, including but not limited to:
- HPLC/UHPLC
- CE-SDS
- cIEF/icIEF
- ELISA
- UV-Vis Spectroscopy
- Compendial testing
- Other biochemical and physicochemical methods as applicable.
- Ensure all testing activities are completed accurately, efficiently, and within established timelines.
- Maintain laboratory notebooks, worksheets, logbooks, and electronic records in accordance with GDP and ALCOA+ data integrity principles.
- 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. LIMS knowledge is a plus.
- Identify and escalate compliance risks during system transition.
- Support analytical method transfer, qualification, verification, and validation activities from Analytical Development or external clients into GMP QC laboratories.
Other Lab Responsibilities/Skills
- Participate in comparability, bridging, and lifecycle management activities for analytical methods and reference standards.
- Perform first-person review of analytical data to ensure completeness, accuracy, and compliance with applicable procedures and regulatory requirements.
- Assist in the preparation and review of: Certificates of Analysis (CoA), Stability Summary Sheets (SSS), Analytical reports, Method qualification and validation reports, technical memoranda and laboratory documentation. Ensure documentation is complete, contemporaneous, attributable, and inspection ready.
- Participate in laboratory investigations involving: OOS, OOT, invalids, and other lab investigations as needed.
- Maintain laboratory equipment records and ensure equipment remains in a qualified state.
- Support laboratory readiness for internal audits, client audits, regulatory inspections, and quality assessments.
- Participate in process improvement initiatives to enhance laboratory efficiency, compliance, and data integrity.
- Collaborate effectively with cross-functional teams including QA, AMD, Manufacturing, MSAT, and Materials Management.
- Support implementation of new technologies, systems, and laboratory processes.
Qualifications
Required Qualifications and Skills:
- 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.
- Direct experience with either Empower CDS or LIMS implementation preferred.
- Strong understanding of GMP regulations and data integrity expectations.
Preferred Skills & Experience:
- 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.
