Quality (QA) Assurance Specialist Greater Boston Area
My client is a multinational biotech firm that is looking to add a Lead Quality Assurance Specialist to team. This is a technical support role assisting other departments within the organization. This role would be assisting departments such as Validation, QC, Facilities, Manufacturing and others as assigned. The Quality Assurance Specialist serves as the QA SME for all activities within the company. Directly providing oversight, and being held responsible for, documents, reports and protocols, as assigned.
- Assist with closure of deviations
- Quality Assurance oversight of validation activities
- Participate on Change Controls related to validation of equipment
- Maintain vendor qualification program through timely audits and follow-up actions
- Review and/or approve deviations, OOSs, CAPAs, Change Controls and further in an efficient manner
- Make recommendations to Quality Assurance Management for the disposition of drug product
- Assist Quality Assurance with GxP training
- Bachelors Degree in a Science or Engineering Discipline
- Minimum of five years of experience in GMP QA (Quality Assurance)
- Past technical, collaborative, experience is required
- Familiarity with FDA and EU regulatory standards
- Excellent communication (Written and Oral)
- Past commercial manufacturing experience
This is an urgent need with my client looking to move fairly quickly. If interested in an opportunity as such please forward your resume to the attention of Ahmed Hassan, and team, with Real Staffing, Boston.
#QualityAssurance #QA #GMP #cGMP #Manufacturing #Support #TechnicalSupport #Lead #Senior
Sthree US is acting as an Employment Business in relation to this vacancy.