Quality Engineer Specialist

4 weeks ago


Rockville, United States Insight Global Full time

One of our large Pharmaceutical clients is seeking a Quality Engineer Specialist to oversee and support an external manufacturer within Advanced Therapeutics in Rockville, Maryland. In this role, you will be providing quality oversight and validation support for manufacturing activities related to commercial operations for production of cell therapy products. You will also be maintaining quality systems and oversight to ensure the validation/qualification and operation of processes and procedures for this external site. Other responsibilities include:

  • Acting as sponsor's representative and main point of contact for manufacturing decisions
  • Providing oversight and approval of system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, qualification protocols, validation plans, and validation summary report
  • Developing and executing protocols and analyzing results for a variety of qualification and validation functions
  • Resolving manufacturing issues and conducting deviation investigations, root cause analysis and the identification and implementation of CAPAs
  • Authoring, reviewing, executing and approving technical documents updates such as SOPs, batch records, change control documents, technical protocols, validation documents and other GMP documentation
  • Driving continuous improvement and process optimization efforts on quality standards, requirements, and overall best practices


Qualifications:

  • Bachelor’s Degree in a Science or Engineering related field of study
  • Minimum 3 years of experience in pharmaceutical manufacturing within cell & gene therapy
  • Minimum 8 years of related quality engineering or validation manufacturing support experience
  • Strong QMS and IQ/OQ/ PQ skills


Pay: $60.00-$70.00/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.



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