Quality Control Specialist

Quality Control Specialist needed!Overview:Seeking a Quality Control (QC) Compliance Investigator who will in advance and close QC related investigations. Strong technical writing skills are required. Experience in a CAR-T or TIL environment is a plus.The ideal candidate will have experience working in a GMP-regulated laboratory with experience in writing investigations.Shifts (2 different ones you can be submitted to): Sun-Wed, 7am-6pm & Sun-Wed, 9am-8pmEssential Functions and Responsibilities:Performs deviation investigations for all areas within Quality ControlPerform out of specification investigations with an emphasis on QC analytical assays (flow cytometry, ELISA, and other cell-based assays) and microbiology assaysWork cross-functionally to create relevant corrective/preventative actions (CAPA).Support maintenance of a database in support of QC metrics and KPI's.Revise quality documents in support of deviation mitigation and/or CAPAs.Support programs to improve on-time closure rates for all quality recordsOther responsibilities as determined.Required Education, Skills, and Knowledge:Bachelor's degree in a relevant discipline (biological sciences or equivalent)1-3 years of experience in the biopharmaceutical industry within a cGMP Quality Control roleBasic knowledge of biological drug development with respect to Quality ControlExtremely detail-oriented with strong analytical, written, and verbal communication skillsDemonstrate sense of urgency; ability to recognize time sensitivityFlexible and adaptable style with an eagerness to take on challengesPreferred Education, Skills, and Knowledge:Experience with cell and/or gene therapy productsGMP regulated laboratory experienceKnowledge of investigation writingThe 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, 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 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.

Created: 2025-03-03