Quality Specialist Job at Insight Global, Gaithersburg, MD

YzdqTjZ5QTV0YkdQR0dEUzhSdkdhU1R5
  • Insight Global
  • Gaithersburg, MD

Job Description

Compensation & Notes:

  • Fully onsite position Mon-Fri in Gaithersburg, MD
  • $45/hr-$48/hr- Exact compensation may vary based on several factors, including skills, experience, and education.
  • Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

Qualifications:

  • Degree in a Science/Engineering-related field required, with preferred focus or experience in pharmaceutical manufacturing
  • Minimum 3–5 years’ experience in pharmaceutical manufacturing, with preference in cell and gene therapy manufacturing
  • Preferred experience working with the CliniMACS Prodigy Instrument
  • Preferred experience with contract manufacturing organizations
  • CAR-T experience

Job Description: This position will perform manufacturing oversight of an external contract manufacturing organization producing a Phase II/III clinical CAR-T program as a person in plant. Additionally, this position will be responsible for supporting the contract manufacturing organization in the following activities:

  • On-the-Floor Technical Support and Issue Triage (rapid response to manufacturing issues, resolution, and communication/escalation)
  • Facility Oversight , including routine GEMBA walks, reporting of observations to the CMO, and supporting improvements where needed
  • Technical Writing/Review for product impact assessments, investigations/deviations, and change controls
  • Support in the execution and implementation of CAPAs
  • Technical Writing/Review for batch records, SOPs, and other documents as needed
  • Support in data transcription and analysis for manufacturing process and release data

Job Tags

Contract work,

Similar Jobs

Rutland Regional Medical Center

RN Emergency Department Job at Rutland Regional Medical Center

 ...RN Emergency Department Responsible for the delivery of safe, effective and quality patient-family centered care in the Emergency...  ...for all patient populations. Emergency Nurses specialize in assessing, intervening and stabilizing a variety of trauma and illnesses with... 

Insight Global

Audio Visual Technician Job at Insight Global

Thank you so much for your interest! This role is a contract to hire local to Downtown Indy (dtown Indy will be the 'home base' location and you essentially support the local area). Mileage can be expensed, but your own car is required. Title : Sr AV Tech Location...

Insight Global

Call Center Representative Job at Insight Global

 ...excellent attendance and shift adherence Communicate clearly and empathetically Embrace feedback and multitask effectively The hourly pay for this position is $30/hr. REQUIRED SKILLS AND EXPERIENCE High School Diploma, GED, or equivalent required.... 

LHH

Property Manager Job at LHH

 ...Site Manager Affordable Housing On-site: Silver Lake, CA Pay: $27 to $32 per hour About the Role We are seeking a highly...  ...in affordable housing programs (e.g., LIHTC, Section 8), property management systems, and team leadership. Key Responsibilities... 

Medical Services of America

Psychiatric Registered Nurse Home Health Part-Time/PRN Job at Medical Services of America

 ...Medi Home Health Agency , a division of Medical Services of America, Inc., currently seeks an experienced Part-Time/PRN Psychiatric Registered Nurse for our Home Health patients in Clearfield, PA. Provides services requiring substantial and specialized nursing...