Quality Operations Specialist II - Night Shift [Contract to Hire]

Iovance Biotherapeutics•Philadelphia, PA

10h•Onsite

About The Position

The Quality Operations Specialist II is a part of the Quality Operations team. The Quality Operations team is responsible for ensuring that all operations at the facility comply with cGMP regulations, as well as internal policies and procedures. The Quality Operations Specialist II works alongside manufacturing personnel, helping to ensure that the highest standard of work is performed. Shift - Wednesday to Saturday from 1800 to 0630.

Requirements

A Bachelor’s Degree in Science, Engineering, or a related technical discipline.
At least two years of experience in a regulated industry.
Working knowledge of cGMP regulations.
Prior experience and ability to work in an aseptic processing environment.
Strong administrative skills including use of Microsoft Word, Excel, and PowerPoint.
Attention to detail.
Weekend and Shift work required.
Must not be color blind
Must have 20/20 near vision in both eyes (can be corrected)
Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
Must meet requirements for and be able to wear a half-face respirator.
Able to stand and/or walk 90% (and sit 10%) of a 10-hr day which may include climbing ladders or steps.
Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
Must be able to lift and carry objects weighing 45 pounds.
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.

Nice To Haves

Knowledge of QMS systems is a plus.

Responsibilities

Helps to ensure compliance to cGMPs and facility procedures.
Interface with functional groups, such as Manufacturing, Quality Control, and Document Control, to determine events (errors, deficiencies, discrepancies, deviations and other observations) and report to management.
Review batch records and related production documentation, ensuring resolution of all identified issues prior product disposition.
Work with internal functions to address all identified issues in a timely manner.
Reports errors, deficiencies, discrepancies and observations to management.
Review QC data.
Support lot release and closure.
Disposition incoming raw materials.
Apply quality compliance theories and principles to independently address a variety of issues of moderate scope.
Provide guidance on controlled documents (content, quality, and document lifecycle), identifying gaps, addressing documentation needs, and suggesting process improvements.
Initiate and participate in standard operating procedure (SOP) revisions to improve compliance.
Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
Perform miscellaneous duties as assigned.