39 Jobs in Bedford, MA
intellectt is Hiring a QA Consultant Near Bedford, MA
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This is Bhanu from Intellectt INC; we’ve got an important role QA Consultant - Bedford, MA with one of our prestigious clients. Interested candidates can please send your updated resume at bhanu@intellectt.com
Role: QA ConsultantLocation: Bedford, MAJob DescriptionA mid-sized bio-pharmaceutical company in the greater Boston area is looking to add a QA Consultant to their team for the next year. This person will work onsite 3-5 days a week at our clients new manufacturing facility in Bedford, MA and will be able to start in late January. Ideal candidates will be local, with 8 years of relevant experience supporting Batch Record Review and Product Disposition
Qualifications
- Bachelor’s Degree is required with 8 years of relevant experience
- Strong background in Batch Record Review experience required
- Strong background in Deviation review experience required
- Experience in a GxP biotechnology or pharmaceutical environment is required, Gene Therapy experience
- Work effectively and collaboratively with external CMOs, and internal cross-functional teams
- The desire to work in a fast-paced environment with occasional shift in priorities
- Ability to communicate effectively in a multi-function team setting a plus
- Provide onsite support at manufacturing plant by supporting review and approval of quality systems records
- Generate documentation required for product release, as well as provide support for all related product release activities
- Ensure on time disposition of Gene Therapy products while ensuring they are in compliance with cGMP and international requirements
- Provides quality expertise in the review of cGMP Manufacturing Batch Records – including Cell Banks, Viral Banks, Plasmids, Drug Substance, Drug Product and Finished Product
- Coordinate timely resolution to batch record review comments
- Review and approve manufacturing associated deviations, & change controls
- Support internal and external QP confirmation and QP certification activities
- Other duties as assigned supporting QA projects and objectives
Ajay BhanuIntellectt Inc
Direct: 732 784 4384Desk number : 732 412 6999- Ext: 159
517 Route 1 South, Suite 1115 Iselin, NJ 08830
WhatsApp: https://chatwith.io/s/bhanu
Job Summary
Contractor
Business Services
$108k-136k (estimate)
06/02/2024
06/25/2024
intellectt.com
ISELIN, NJ
200 - 500
2018
KIRAN MADALA
$5M - $10M
Business Services
Related Companies
About intellectt
Intellectt Inc. was founded to set a new standard in Consulting and Staffing Industry. Our company is made up of dreamers, calculated risk-takers, diligent people that go to fight for the brand of our client. Intellectt Inc. and our affiliated brands provide innovative talent solutions that make our clients businesses better. Our verticals include Healthcare and IT. We exist to become the finest and most esteemed staffing company across the USA and we look forward to putting our talents to use to push your organization forward.
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