What are the responsibilities and job description for the Specialist I, Quality Assurance position at Abeona?

Job Description

JOB TITLE	SPECIALIST I, QUALITY ASSURANCE – QUALITY SYSTEMS
Department	Quality Assurance – Quality Systems
Reports To	Supervisor, Quality Assurance – Quality Systems or above
Ladder Level	2

DESCRIPTION

Position Overview

The Specialist I, Quality Assurance performs routine activities associated with manufacturing of cell and gene therapy products at the Abeona Therapeutics Inc. site in Cleveland, OH. This position supports the maintenance of the quality systems in support of a cGMP Operations, corrective and preventative actions, quality events management (e.g., nonconformances, deviations, etc.), training, document management and ensuring procedural and regulatory compliance throughout the manufacturing process. The Specialist I, Quality Assurance will report to the Supervisor, Quality Assurance or above.

Essential Duties and Responsibilities

Position is Day Shift with occasional weekends (as needed)

Performs the following duties with minimal supervision.
Ensure minor non-conformances are fully investigated and effective corrective/preventive actions (CAPA) are implemented in a timely manner.
Support change management processes including formal change controls.
Review and approve controlled documents including standard operating procedures, work instructions, etc.
Support site inspections, as needed.
Work closely with functional groups to ensure processes and personnel remain in compliance with site procedures, regulatory and cGMP guidelines.
Enhance skills via regular training and continuing education, including professional society membership/participation.
Perform other duties as required.

Qualifications

Minimum of a Bachelor’s degree in related field and/or equivalent experience.
Minimum of 1 year of experience in quality and/or manufacturing in a pharmaceutical, biotech, or biologics cGMP regulated manufacturing environment preferred.
Working knowledge of quality systems and ability to apply cGMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards.
General knowledge of aseptic manufacturing processes.

Competencies

Excellent organizational skills, attention to detail, and Good Documentation Practices.
Proficiency in MS Word, Excel, Power Point, Microsoft Office 365 and other applications.
Must possess effective interpersonal, verbal, and writing skills, patience, professionalism, and the ability to effectively interact and communicate with internal staff and management.
Comfortable in a fast-paced, patient-focused manufacturing environment with minimal direction and able to adjust workload based on changing priorities.

Working Accommodations

This is a flexible work role. This position is eligible to work remotely on a periodic basis based on site needs. The position has flexibility in conducting some work activities remotely while also having work that requires him/her to be at the office on a regular basis. All days working remotely require manager approval.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to experience prolonged sitting, some bending, stooping, and stretching. Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. A normal range of hearing and vision correctable to 20/20 is required. Occasional lifting up to 20 pounds is required.

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