Quality Control Compliance Investigator II Wed Sat 7AM 6PM and Wed Sat 9AM to 8PM
Quality Control Compliance Investigator II Wed Sat 7AM 6PM and Wed Sat 9AM to 8PM
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Salary Not Disclosed
1 Vacancy
Job Description
Overview
The Quality Control (QC) Compliance Investigator II will assist the QC Compliance Manager in advancing and closing QC related investigations. Strong technical writing skills are required. Experience in a CART or TIL environment is a plus.
The ideal candidate will have experience working in a GMPregulated laboratory with knowledge of writing investigations.
Shifts available:
Sunday to Wednesday from 7am 6pm
Wednesday to Saturday from 7am 6pm
Essential Functions and Responsibilities
Performs root cause analysis and investigations in response to audits deviations out of specification/lab investigations and corrective/preventative actions (CAPA).
Work crossfunctionally to support deviations and Out of Specification investigations with an emphasis on analytical assays (flow cytometry ELISA and other cellbased assays) and Microbiology assays.
Gather data in support of deviations and maintain a trending database of applicable metrics.
Revise Quality documents in support of deviation mitigation and/or CAPAs.
Other responsibilities as determined.
Required Education Skills and Knowledge
Bachelors degree in a relevant discipline (biological sciences or equivalent)
35 years of experience in the biopharmaceutical industry within a cGMP Quality Control role
Basic knowledge of biological drug development with respect to Quality Control
Extremely detailoriented with strong analytical written and verbal communication skills
Demonstrate sense of urgency; ability to recognize time sensitivity
Flexible and adaptable style with an eagerness to take on challenges
Preferred Education Skills and Knowledge
Experience with cell and/or gene therapy products
GMP regulated laboratory experience
Knowledge of investigation writing
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 Sit for an extended amount of time in front of the computer or biological safety cabinet
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 lab setting.
When in the lab must be able to work in Lab setting with various chemical/biochemical exposures including latex and bleach.
Able to work in cleanroom with biohazards human blood components and chemicals.
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.
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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Required Experience:
Senior IC
Employment Type
Full-Time
