QC Associate I/II - Contract

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, IEF/icIEF, ELISA, UV-Vis Spectroscopy, Compendial testing, and 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.

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.

Abzena

We are 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 laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans.