Quality Control Analyst II (QC Analytical) - 2ND SHIFT (4PM- 12AM)

Abeona Therapeutics Inc. • Cleveland, OH

39d • $68,000 - $82,000 • Onsite

About The Position

The Quality Control Analyst II performs routine laboratory activities in support of Good Manufacturing Practices (GMP) testing for Quality Control (QC). Testing includes qPCR, immunoassays and cell culture-based potency assays. Supports the authorship and revision of GMP documentation. Interacts with employees internal and external to Quality Control. This position will work from 4:00 PM to 12:00 AM, Monday to Friday. Training will be on first shift for four to six months (subject to change based on company need).

Requirements

• 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, immunostaining, and drug product potency testing preferred.
• Experience with DEV, CAPA and CR management 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.

Responsibilities

• Performs other duties as assigned by management.
• Works on QC tasks of diverse scope, requiring basic knowledge of laboratory concepts.
• Train new employees on Quality Control process flows and testing methods.
• Author and revise existing Standard Operating Procedures (SOPs), testing forms and product specifications (SPCs).
• Perform advanced cell culture techniques such as seeding culture dishes, transductions, and immunostaining according to approved test methods.
• 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.
• Proactively communicates laboratory issues to supervisor or manager.
• Supports laboratory investigations related to test failures, discrepancies and deviations.
• Helps maintain the laboratories in a GMP compliant state, including participating in cleaning, instrument routine and preventative maintenance, logbook use, etc.

Benefits

• Medical insurance coverage (multiple options to meet our employees' and their families' needs)
• Dental and vision coverage
• 401k match plan
• Lifestyle spending account
• Annual Compensation: $68,000 - $82,000 (includes shift differential)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Number of Employees: 101-250 employees