The Role
The Quality Control Sr. Analyst I is responsible for driving laboratory activities in GMP testing, conducting training for new hires, and interacting with QC personnel. This role includes authoring SOPs, reviewing documentation, improving QC systems, and handling laboratory investigations related to test failures.
Summary Generated by Built In
DESCRIPTION
Position Overview
The Quality Control Sr. Analyst I uses knowledge to help drive routine laboratory activities in support of Good Manufacturing Practices (GMP) testing for Quality Control (QC). Supports Environmental Monitoring (EM) activities. Responsible for the timely execution of laboratory testing and investigations into out of specification results. Responsible for tracking and trending, as well as Environmental Monitoring Assessments. Interacts with employees internal and external to Quality Control. Essential Duties and Responsibilities
The Quality Control Sr. Analyst I uses knowledge to help drive routine laboratory activities in support of Good Manufacturing Practices (GMP) testing for Quality Control (QC). Supports Environmental Monitoring (EM) activities. Responsible for the timely execution of laboratory testing and investigations into out of specification results. Responsible for tracking and trending, as well as Environmental Monitoring Assessments. Interacts with employees internal and external to Quality Control. Essential Duties and Responsibilities
- Works on QC tasks of diverse scope, requiring higher knowledge of laboratory concepts.
- Conduct training of new hires using Abeona’s On-the-Job-Training (OJT) aides.
- Serve as a backup analyst for Environmental Monitoring, growth promotion, incubating/reading plates, isolating/banking organisms, and any other EM related activities using standard techniques in biochemistry, molecular biology and cell biology, and according to approved test methods.
- Author and revise analytical methods, SOPs, test forms, and product specifications (SPCs).
- Review documentation including critical process forms, environmental monitoring data, growth promotion forms, banking forms, etc.
- Participates in validation/qualification of methods transferred into the QC laboratory.
- Drive process Improvements to QC systems and procedures to improve GDP compliance.
- Proactively communicates laboratory issues to 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).
- Helps drive process improvements related to QC systems and procedures to improve GMP compliance.
- Serves as primary author of laboratory investigations related to test failures, discrepancies and deviations.
- Serve as second analyst in Out of Specification (OOS) testing.
- Helps maintain laboratory in GMP compliant state, by scheduling lab cleanings, instrument routine and preventative maintenance, review of logbooks, etc.
- Sends samples to third party organizations for identification and sterility testing.
- Performs Environmental Monitoring Assessments as a part of release testing.
- Performs quarterly and yearly tracking and trending of the manufacturing facility.
- Support authorship of studies and validations.
- Performs other duties as assigned by management.
- BS in biochemistry, biology, microbiology, molecular biology or other relevant discipline with 5 to 7 years of relevant experience.
- Experience and knowledge in the pharmaceutical and/or biotech industry within a GMP and/or GLP environments preferred.
- Experience in tracking and trending preferred.
- 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.
Top Skills
Biochemistry
Molecular Biology
The Company
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
