Overview
Quality Assurance Specialist Jobs in Norwood, MA at Randstad USA
Title: Quality Assurance Specialist
Company: Randstad USA
Location: Norwood, MA
IMMEDIATE HIRE – cGMP QC STABILITY PROGRAM SPECIALIST
How does it sound to be part of a groundbreaking Biotechnology company pioneering in harnessing the power of mRNA technology creating innovative medicines and vaccines?
We’re looking for a detail-oriented and proactive Stability Documentation Specialist to oversee data readiness and document management across our global stability team. In this dynamic role, you’ll play a key part in coordinating critical stability documentation, collaborating with QC stability and cross-functional teams, and ensuring adherence to GMP guidelines and regulatory commitments. APPLY TODAY.
Location:
Norwood, MA.
Shift:
M – F, 1st shift.
Pay Rate:
$45 – $50/hour (based on qualifications and experience).
What you will be doing:
In this role, you will oversee data readiness and document management for the global stability team, focusing on timely submission and coordination of stability documentation. You’ll collaborate with stakeholders to ensure GMP compliance and support QC teams with data verification and approval processes.
Key Responsibilities:
Coordinate with stability teams to ensure data readiness and timely Health Authority (HA) updates.
Prepare, author, and maintain regulatory sections related to stability.
Oversee creation of core data documents for regulatory submissions.
Assist QC stability teams with data transcription and verification during process transitions.
Ensure timely approval of core documents to meet submission deadlines.
Support APQR stability section preparation and refine key global stability documents (e.g., Post-Approval Stability Protocols, OOT Forms, SOPs).
Deploy stability strategy.
The right candidate will have:
Completed Bachelor’s Degree in Biology, Chemistry, Biochemistry, Chemical engineering, Biomechanical Engineering, Bioengineering, Biomedical Engineering, or related STEM field discipline.
2-5 years’ experience in the biotechnology/biopharmaceutical industry, or other cGMP regulated industry.
Project management skills: Ability to effectively manage data and document workflows using Advanced Microsoft Word and Excel.
LIMS experience (i.e.: VEEVA).
A general understanding of stability testing and protocols in a GMP environment.
TO APPLY: Email Resume to: [email protected]
If this job is not for you, feel free to refer a friend.
