DESCRIPTION
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.
Essential Duties and Responsibilities
- Works on QC tasks of diverse scope, requiring basic knowledge of laboratory concepts.
- Train on 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.
- Helps maintain 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
- BS in biochemistry, biology, microbiology, molecular biology or other relevant discipline with 1 to 3 years of relevant experience.
- Experience and knowledge in the pharmaceutical and/or biotech industry within a GMP and/or GLP environments preferred.
- Experience in microbiological assays.
- Understanding of basic scientific concepts in one or more areas above.
- Experience with relevant analytical lab equipment and computers preferred.
- Good mathematical and organizational skills
- Ability to interact constructively with co-workers to solve problems and complete tasks
- Some weekend work or late nights may be required periodically.
- Occasional travel (less than 20%) to train on visual inspection of the drug product.
Physical Demands
- A normal range of hearing and vision correctable to 20/20, and Occasional lifting up to 25 pounds is required.
Top Skills
What We Do
Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing cell and gene therapies for serious diseases. Prademagene zamikeracel (pz-cel) is Abeona’s investigational autologous, COL7A1 gene-corrected epidermal sheets currently in development for recessive dystrophic epidermolysis bullosa. The Company’s fully integrated cell and gene therapy cGMP manufacturing facility served as the manufacturing site for pz-cel used in its Phase 3 VIITAL™ trial, and is capable of supporting commercial production of pz-cel upon FDA approval. The Company’s development portfolio also features AAV-based gene therapies for ophthalmic diseases with high unmet medical need. Abeona’s novel, next-generation AAV capsids are being evaluated to improve tropism profiles for a variety of devastating diseases
