GMP QUALITY SPECIALIST - CELL THERAPY

Company: Insight Global
Location: Rockville
Posted on: August 26, 2024

Job Description:

One of our large Pharmaceutical clients is seeking a GMP Quality Specialist to oversee and support an external manufacturer within Advanced Therapeutics in Rockville, Maryland. In this role, you will be providing quality oversight for daily activities related to commercial operations supporting production of cell therapy products. Responsibilities include:

• Acting as sponsor's representative and main point of contact for manufacturing decisions
• Resolve manufacturing issues along with daily review of manufacturing investigations, change controls, deviations and out of specifications
• Work to drive compliance to limit non-conformances
• Perform reviews of batch records, procedures, documentation, and audits
• Adhere with cGMP requirements along with general safety policies, implementing process improvements
  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 within cell & gene therapy
  • Minimum 2 years of experience of technical writing
  • Strong in Root Cause Analysis in a Pharmaceutical environment
    Pay: $45.00-$50.00/hr (flexible based on experience)Hours: Monday-Friday, 8:00am-4:30pmHiring Method: 6 month long contract with high likelihood for extension and/or permanent hireSick Time: Paid Holidays & 6 paid sick days annuallyBenefits: Medical, Dental, Vision and 401K plans available
    Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 31st 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.

Keywords: Insight Global, Rockville , GMP QUALITY SPECIALIST - CELL THERAPY, Healthcare , Rockville, Maryland