Quality Control Analyst - Micro Analytical

Job Description

Job Description

Our Values : Patient First | Innovation | Integrity | Determination | Trust

Join us in making cure the new standard of care. At Abeona Therapeutics , we exist for our patients and their caregivers; their needs guide our decision-making. We challenge ourselves to think differently, move quickly, and deliver solutions. We hold ourselves to the highest ethical and quality standards. We persevere with resilience and focus to achieve our mission. We build trust through humility, mutual appreciation, openness, and respect.

Position Overview

The Quality Control Analyst I performs routine laboratory activities in support of Good Manufacturing Practices (GMP) testing for Quality Control (QC). Performs in-process and release testing for drug substance and drug product. Interacts with employees internal and external to Quality Control. This position is a split-shift position : 10 : 00 AM - 6 : 00 PM Monday through Friday.

Essential Duties and Responsibilities

• Works on QC tasks of diverse scopes, requiring basic knowledge of laboratory concepts.
• Train in applicable Standard Operating Procedures (SOPs) and Methods.
• Perform endotoxin, gram stain, bioburden, rapid sterility testing, and visual inspection of the drug product and drug substance using standard techniques in biochemistry, molecular biology and cell biology, and according to approved test methods.
• Proactively communicates laboratory issues to supervisor or manager. Initiates laboratory investigations related to test failures, discrepancies and deviations.
• Completes laboratory work with precision and maintains hardcopy paperwork and electronic data in an organized manner, in compliance with company documentation practices (GDP).
• Provides input to improving QC systems and procedures to improve GMP compliance.
• Assist with maintaining the laboratories in a GMP compliant state, including participating in cleaning, instrument routine and preventative maintenance, logbook usage and review, etc.
• Performs other duties as assigned by management.

Qualifications

Physical Demands

A normal range of hearing and vision correctable to 20 / 20, and Occasional lifting up to 25 pounds is required. Must be comfortable sitting or standing for extended periods of time.

Visa Sponsorship Not Currently Available

IMPORTANT : Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.