Quality Assurance Specialist

SPECTRAFORCE; Harvard (MA); On-site; USD 50,000 - 70,000; Full time

Job summary

A leading staffing agency in Massachusetts is seeking a Quality Assurance Specialist for the 2nd shift/overnight role. This position requires 2-3 years of manufacturing experience and the ability to work on the floor for the majority of the shift, ensuring compliance with GMP standards. Responsibilities include managing label control tasks, performing apheresis-related duties, and participating in training for compliance. Familiarity with systems like SAP and MES is advantageous, making this an excellent opportunity for qualified candidates.

Qualifications

• 2-3+ years of experience in manufacturing is required.
• Experience with GMP gowning is mandatory.
• Experience with label control, MES, and SAP is a plus.

Responsibilities

• Manage label control tasks and logbook.
• Conduct floor operations during shifts.
• Perform apheresis-related tasks.
• Gown and maintain compliance with GMP standards.

Skills

Manufacturing experience

GMP compliance

Label control

Tools

SAP

MES

Syncade

Veeva

Trackwise

DeltaV

LIMS

Job description

Overview

Job Title: QASF (Quality Assurance Specialist, Floor)

2nd Shift/Overnight

Training

• The first three weeks will be training (Monday-Thursday Normal Hours)
• Topics include gowning, MES, SAP, Label QA, GPS, and Polestry.

Responsibilities

• Execution of label control tasks and logbook management.
• Floor operations (70-80% of their shift will be on the floor).
• Apheresis-related tasks.
• Gowning and working in compliance with GMP standards.

Qualifications

• 2-3+ years of MFG experience (mgrs are looking for someone with experience)
• Experience with label control, MES (Manufacturing Execution Systems), and SAP is NOT Required but would be gladly welcomed.
• Prior GMP gowning experience (Grade 8 gowning minimum requirement).
• Syncade, SAP, Veeva, Trackwise, electronic batch records, DeltaV, LIMS, Lab Notebooks are all pluses.