GMP Quality Specialist - Cell & Gene Therapy - Insight Global

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:

• Performing review and approval of technical documents, raw material specifications, DPFD/Regulatory filings, analytical methods and master batch records to confirm products and processes comply with cGMP requirements.
• Providing quality oversight for production activities in plant, including identification of risks, deviation and CAPA management, change control, and batch documentation review.
• Completing EM quality performance monitoring and proactive identification of risks as well as identifying nonconforming, out of trend, or out of specification results.
• Collaborating with onsite teams, stakeholders and SMEs (Operations, Planning, Technical Operations, ect) to help identify, assess and remediate any deficiencies in order to continuously enhance quality performance.

Qualifications:

• Bachelor's Degree in a Science or Engineering related field of study
• Minimum of 5 years’ of GMP Quality Assurance Documentation experience
• Minimum of 2 years' of experience supporting Cell & Gene Therapy programs
• Minimum of 5 years' of Root Cause Analysis, Deviations, CAPAs and QMS experience

Pay: $45.00-$53.00/hr (flexible based on experience)

Hours

Monday-Friday, 8:00am-4:30pm

Hiring Method: 6 month long contract with high likelihood for extension and/or permanent hire

Sick Time: Paid Holidays & 6 paid sick days annually

Benefits: 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.