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Quality Control Raw Materials - Analyst II

Cleveland, OH

Full Time

Mid Level

QUALITY CONTROL RAW MATERIALS - ANALYST II

Department: Quality and Compliance

Reports to: Supervisor or Manager, Quality Control

Description:

The Quality Control Raw Materials Analyst II performs routine laboratory activities in support of

Good Manufacturing Practices (GMP) testing for Quality Control (QC). Performs raw material

release testing. Supports the authorship and revision of GMP documentation. 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.

· Perform Raw Material Release testing (i.e. plate-based methods, SDS PAGE, Cell Culture)

using standard techniques in biochemistry, molecular biology and cell biology, and according

to approved test methods.

· Author and revise existing Standard Operating Procedures (SOPs), testing forms and

product specifications (SPCs).

· Proactively communicates laboratory issues to supervisor or manager. Initiates laboratory

investigations related to test failures, discrepancies and deviations, and supports

investigations.

· 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 use, etc.

· Conduct training of new hires using Abeona’s On-the-Job-Training (OJT) aides.

· Performs other duties as assigned by management.

Qualifications

· BS in biochemistry, biology, microbiology, molecular biology or other relevant discipline with

3 to 5 years of relevant experience.

· Experience and knowledge in the pharmaceutical and/or biotech industry within a GMP

and/or GLP environments preferred.

· Experience in cell culture 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.

Physical Demands

A normal range of hearing and vision correctable to 20/20, and Occasional lifting up to 25 pounds

is required.

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