Quality Control Biochemistry Associate II

QC Associate II

The QC Associate II will support Biochemistry Quality Control activities for large molecule products, contributing to testing, method transfer, validation, and laboratory operations within a GMP-regulated environment. This role is responsible for performing in-process and release testing, supporting investigations, and ensuring the integrity and accuracy of laboratory results. The ideal candidate will have hands-on laboratory experience, a strong understanding of quality systems and compliance requirements, and the ability to collaborate effectively with Quality, Manufacturing, and cross-functional teams.

Key Responsibilities

• Perform in-process and release testing of large molecule products.
• Execute method transfer and validation testing activities.
• Conduct analytical testing including:
• pH
• Appearance
• Osmolality
• Protein Concentration (UV, RI, and SoloVPE)
• Support laboratory investigations and perform testing related to investigational activities.
• Ensure accurate and timely documentation of testing activities and results.

• Support QC Biochemistry operations in alignment with business and manufacturing schedules.
• Assist with process validation initiatives and related testing activities.
• Collaborate with Quality and Manufacturing teams to support production timelines and quality objectives.

• Maintain effective laboratory systems to ensure data integrity and reliable test results.
• Adhere to all GLP and GMP requirements, company procedures, and quality standards.
• Contribute to continuous improvement initiatives and support audit readiness activities.

Qualifications

• Bachelor's degree in a scientific discipline preferred (Biology, Biochemistry, Chemistry, Microbiology, or related field). REQUIRED

• Master's degree with 2+ years of relevant laboratory or quality control experience, OR
• Bachelor's degree with 3+ years of relevant laboratory or quality control experience.

• Experience working in a GMP-regulated pharmaceutical, biotechnology, or life sciences environment.
• Knowledge of biochemistry testing methods and laboratory instrumentation.
• Experience supporting method validation, method transfer, and quality investigations.
• Strong attention to detail and documentation skills.
• Excellent verbal and written communication skills.
• Ability to work independently while collaborating effectively across departments.