Quality Systems Specialist Ii - Philadelphia, United States - Iovance Biotherapeutics Inc

Iovance Biotherapeutics Inc

Verified Company

Philadelphia, United States

2 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Overview

Essential Functions and Responsibilities

Maintain the electronic Quality Management System (eQMS), with emphasis on Deviation, CAPA, and Change Control processes
Provide user support to the eQMS system users
Run reports and conduct data analysis to support tracking of change controls, deviations, and CAPAs to ensure timely closures of records
Implement, enhance, and maintain QMS procedures and work instructions based on best practices or compliance requirements
Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS
Represent the Quality System group in crossfunctional projects where applicable
May participate in internal audits or regulatory inspections (e.g. prep room participant, runner, etc.)
Support training activities and backup efforts for Quality Systems processes
Maintain updated knowledge and relevant assessments of the GxP landscape, regulations, and guidelines
Support management with other Quality Systems related tasks

Basic Qualifications

BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study from an accredited university or college with 5+ years of relevant experience
Current and working knowledge of Code of Federal Regulations and International Council for Harmonization Guidelines governing current Good Manufacturing Practices for Pharmaceuticals
Experience with an electronic QMS, Master Control preferred
Must be comfortable in a fastpaced environment with mínimal direction and changing priorities
Strong interpersonal skills and ability to work collaboratively with colleagues crossfunctionally
Strong computer skills including MS Office (Word, Excel, PowerPoint, MS Project)

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully.

Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required:

Ability to stand/sit/walk for long periods of time.
Ability to crouch, bend, twist, reach, and perform activities with repetitive motions.
Must be able to work in environment with variable noise levels.
Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.

Mental:

Clear and conceptual thinking ability; excellent judgment, troubleshooting, problemsolving, analysis, and discretion; ability to handle workrelated stress; ability to handle multiple priorities simultaneously; and ability to meet deadline

Work Environment:

This position will work in both an office and a manufacturing setting.
When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
Potential exposure to noise and equipment hazards and strong odors.

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description.

They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

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