What are the responsibilities and job description for the GMP Quality Assurance Consultant - Cell & Gene Therapy position at Stark Pharma Solutions Inc?
Hi,
My name is Sravani Dasari from Vakula Tech Inc. We are hiring talented professionals for a GMP Quality Assurance Consultant – Cell & Gene Therapy position. If you have relevant experience and are interested in this opportunity, please send me your updated resume.
Position: GMP Quality Assurance Consultant – Cell & Gene Therapy
Location: Boston, MA
Duration: Long Term
Job Overview
We are seeking an experienced GMP Quality Assurance Consultant to provide quality oversight and compliance support for Cell & Gene Therapy manufacturing operations, validation, laboratory, engineering, and capital projects in a GMP-regulated environment.
Key Responsibilities
- Provide GMP QA oversight for manufacturing operations, validation, analytical laboratories, and engineering activities.
- Review and support Change Controls, Validation Protocols, Risk Assessments, GMP Investigations, and CAPA.
- Support equipment qualification, calibration, preventive maintenance, and laboratory operations.
- Review equipment, facility, and utility trending programs.
- Support environmental monitoring (EM), routine testing, and facility control systems.
- Collaborate with cross-functional teams to ensure GMP compliance and timely issue resolution.
Required Qualifications
- 5–8 years of GMP Quality Assurance experience in pharmaceutical, biotechnology, or Cell & Gene Therapy environments.
- Experience supporting GMP manufacturing operations, validation, and capital projects.
- Strong knowledge of GMP, QA, CAPA, Root Cause Analysis, Change Control, Risk Assessments, and aseptic processing.
- Experience with Veeva, Nuvolo, ViewLinc, or similar quality management systems.
- Bachelor's degree in Engineering, Life Sciences, or a related field (Master's preferred).
- Excellent communication, analytical, and problem-solving skills.
I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.
Please follow Vakula Tech Inc. on LinkedIn for the latest job updates:
https://www.linkedin.com/company/vakula-tech
Thank you,
Sravani Dasari
Talent Acquisition Specialist
Vakula Tech Inc.
Email: jobs@vakulatech.com
Piscataway, New Jersey 08854
Website: www.vakulatech.com