GMP Quality Assurance Lead III - The Fountain Group
Waltham, MA
About the Job
The Fountain Group are a national staffing firm and are currently seeking a GMP Quality Assurance Lead III for a prominent Pharmaceutical client of ours. This position is in Waltham, MA (Hybrid Role). Details for the position are as follows:
Job Description:
Job Description:
- Pay: 75.00-85.00/hr.
- Length of Assignment: 1 year with potential to extend or convert.
- Hybrid role in Waltham, MA. Number of days onsite negotiable.
- Reviews and approves Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated manufacturing documents for the timely initiation of GMP manufacturing activities.
- Provides Quality oversight and Quality guidance to resolve compliance issues for lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials.
- Reviews and Approves Analytical related documents such as Test Methods, Test Method Transfer Plans and Assessments.
- Working knowledge and ability to apply Quality principles and cGMPs in conformance to standards, preferably gained from working in a manufacturing, QA or QC environment.
- Experience with outsourced manufacturing and testing operations.
Source : The Fountain Group
