Entry-Level Qc Analyst

Overview

• Join a dynamic team as an Entry-Level QC Analyst, contributing to innovative gene therapy programs in a GMP-regulated environment.
• Gain hands-on experience with cell-based bioassays, ELISAs, and other biological methods supporting AAV-based gene therapy initiatives.
• Work collaboratively with internal teams and external partners to ensure quality control excellence.
• Develop technical expertise in immunoassays and cell culture maintenance, enhancing your professional skills.
• Contribute to drafting and reviewing SOPs and technical documents, ensuring compliance with regulatory standards.
• Participate in method transfer, reagent qualification, and assay-related activities under expert guidance.
• Engage in investigations and deviation reports, fostering problem-solving abilities in a regulated lab environment.
• Ideal for recent graduates or early-career professionals eager to advance in the field of gene therapy QC.

Key Responsibilities & Duties

• Perform immunoassays and cell-based assays under supervision to support product release and stability testing.
• Assist in drafting and reviewing standard operating procedures and technical documents.
• Support method transfer, qualification of critical reagents, and assay-related activities.
• Participate in the review and basic trending of QC data to ensure accuracy.
• Maintain laboratory upkeep, including cell culture maintenance and instrument calibration.
• Collaborate with internal teams and external partners for cross-functional project support.
• Contribute to investigations and deviation reports under guidance from senior staff.
• Ensure compliance with GMP regulations and quality standards in all activities.

Job Requirements

• Bachelor’s degree in Cell Biology, Molecular Biology, Biochemistry, or related scientific field required.
• Academic or internship experience with mammalian cell culture and ELISAs preferred.
• Familiarity with basic laboratory techniques and data analysis methods essential.
• Strong organizational, communication, and interpersonal skills are critical for success.
• Detail-oriented with enthusiasm for learning in a regulated lab environment.
• Ability to work both independently and collaboratively within a team setting.
• Commitment to maintaining high standards of quality and compliance in all tasks.