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SalaryGreat opportunity to get your foot in the door with one of the top Biotech companies in the Waltham, Ma area!
Description:
- Assist with vendor audit
- Assist Raw Material program
- Manage Deviation, CAPA, Change Control programs
- Implement and Validate new QMS systems
- Help with document control and ensure all documents are in compliance
- Generate, Issue, and reconcile controlled documents for the GMP manufacturing environment
- Adhere to all cGMPs, compliance/regulatory mandates and quality requirements
Work Environment
Monday-Friday you will be working on a team of 5 people. You will be working in a lab, no ppe, no certs.
Additional Skills & Qualifications:
- Bachelor’s degree in a relevant discipline with a minimum of 3 years of experience in FDA-regulated industry
- Experience in reviewing and creating controlled documents
- Technical Writing
- Previous experience with QMS systems and implementation
- Experience with Veeva DMS, QMS
- Experience working with vendor management
Top Skills' Details:
- Quality Assurance
- Veeva
- CAPA
- Deviation
- Change Control
- Vendor Management
- QMS
Job Type: Full-time
Pay: $80,000.00 - $105,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
Ability to Relocate:
- Waltham, MA: Relocate before starting work (Required)
Work Location: In person
