Specialist I Quality Assurance QA IOVA-A QA Ops Contract to Hire

Overview

Specialist I Quality Assurance (QA) IOVAA QA Ops role is responsible for daytoday Quality Assurance Operations activities. This role will work onsite alongside manufacturing and quality control personnel helping to ensure that the highest standard of work is performed for Iovances inhouse iPBMC manufacturing activities at 700 Spring Garden St Philadelphia PA. which is colocated at the American Red Cross Penn Jersey Region. This role is collaborative organized innovative flexible with a strong desire to learn and take ownership and accountability.
The Specialist I supports Quality Assurance lot release and disposition activities including process observation batch record review and completion of lot release documentation. The Specialist I supports Quality Assurance initiatives including but not limited to review of laboratory investigations and deviation investigations. The role supports internal teams and be able to effectively communicate bidirectionally in a complex changing and fastpaced environment.

2nd shift TuesdayFriday 2:30pm 12:30a

34 weeks of Training on first shift Monday Friday 7:00am 5:30pm

Essential Functions and Responsibilities

Quality Assurance Operational Support:
Perform QA Operations activities that include review of manufacturing batch records and labeling/packaging operations to ensure timely release of cell therapy products.
Support quality assurance processes controls and batch history files for QA Operations and Lot Disposition
Perform realtime onthefloor support for manufacturing production activities to ensure compliance with GMP and GDP quality initiatives escalating issues as required.
Track and communicate standard work completion and hurdles.
Actively interact with Contract Manufacturing Organizations (CMO) and internal teams to ensure efficient and timely batch release.
Maintain a collaborative and professional relationship with CMOs.
Release of raw materials and inventory.
Prepare and organize release documentation for approvals.
Support internal audits and regulatory inspections.
Subject Matter Expertise:
Support the efficient and timely review of laboratory investigations and deviation investigations.
Initiate and participate in standard operating procedure (SOP) revisions to improve compliance.
Experience with cell therapy products and/or relevant skills.

General:
Ability to work effectively on multiple projects simultaneously.
Excellent oral and written communication skills
Must possess a high level of attention to detail.
Ability to identify and resolve quality issues with others in a proactive diplomatic flexible and constructive manner.
Strong computer organizational and compliance skills. Proficient with Microsoft Office Suite Word Excel and PowerPoint
Must be comfortable in a fastpaced environment with changing priorities.
Support QA and Logistics activities for ongoing projects.
Assist with implementing GMP QA procedures
Other duties as assigned.

Required Education Skills and Knowledge
BA/BS or equivalent in Biological/Physical/Chemical sciences engineering or equivalent focus of study from an accredited university or college.
At least 2 years demonstrating proficient GMP QA/QC experience.
Experience with use of an electronic QMS (i.e. MasterControl Veeva)
Familiarity with Code of Federal Regulations and International Council for Harmonization Guidelines governing current Good Manufacturing Practices for Pharmaceuticals
Knowledge of GMP Good Documentation Practices (GDP) and FDA quality systems.
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
Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
Must be able to perform cleanroom gowning and pass gowning qualification.
Must meet requirements for and be able to wear a halfface respirator.
Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift carry push pull or otherwise move objects.
Must have visual acuity to perform activities such as: preparing and analyzing data and figures viewing a computer screen and extensive reading.
This position requires repetitive motion substantial movements (motions) of the wrist hands and/or fingers.
Must be able to communicate with others to exchange information. 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 deadlines Work Environment

This job works in a professional office environment and a manufacturing cleanroom setting. Potential exposure to latex bleach loud noise lab equipment hazards strong odors and chemicals/biochemicals is possible. Requires operating standard office equipment and keyboards. 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. Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equalopportunity employer our employees and applicants will be considered without regard to an individuals race color religion sex pregnancy national origin age physical and mental disability marital status sexual orientation gender identity gender expression genetic information military and veteran status and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities please contact .

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