Quality Systems Specialist Ii

2 months ago

Philadelphia, United States Iovance Biotherapeutics Inc Full time

**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 cross-functional projects where applicable
- May participate in internal audits or regulatory inspections (e.g. prep room participant, runner, etc.)
- Support training activities and back-up 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 fast-paced environment with mínimal direction and changing priorities
- Strong interpersonal skills and ability to work collaboratively with colleagues cross-functionally
- 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, problem-solving, analysis, and discretion; ability to handle work-related 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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