QA Specialist — GMP & FDA Compliance, Batch Review

Adecco US, Inc.; St. Albans (VT); On-site; USD 65,000 - 80,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Short-term disability

401K plan

Paid Sick Leave

Holiday pay

Commuter benefits

EAP program

Job summary

Adecco US, Inc. is assisting a client in St. Albans, VT in their search for a Quality Assurance Specialist for a long-term assignment on 1st shift, Monday-Friday, 8:00 AM-5:00 PM.

The role focuses on ensuring batch production records, manufacturing operations, and process documentation comply with cGMP requirements, SOPs, FDA regulations, and other quality standards. Ideal candidates will hold a Bachelor’s degree with 0-2 years in a GMP-regulated environment, plus strong attention to detail,

Qualifications

• Bachelor’s degree required.
• 0-2 years of experience in a GMP-regulated environment.
• Understanding of Quality Systems, cGMPs, and FDA regulations.
• Strong attention to detail, organization, communication and critical thinking.

Responsibilities

• Review in-process and finished product batch records and analytical documentation.
• Release intermediate materials.
• Assess manufacturing operations and documentation for GMP and SOP compliance.
• Support investigation and triage of deviations, events, and unplanned activities.
• Ensure deviations are properly documented and reported.
• Participate in continuous improvement initiatives and quality system projects.
• Perform annual retain inspections.
• Assist with revisions to SOPs, quality forms, and training materials.

Skills

Attention to detail

Organization

Communication

Critical thinking

Education

Bachelor's degree

Tools

Microsoft Office

TrackWise

Documentum

LIMS

SAP

Minitab

Job description

Adecco US, Inc. is assisting a client in St. Albans, VT in their search for a Quality Assurance Specialist for a long-term assignment on 1st shift, Monday-Friday, 8:00 AM-5:00 PM.

The role focuses on ensuring batch production records, manufacturing operations, and process documentation comply with cGMP requirements, SOPs, FDA regulations, and other quality standards. Ideal candidates will hold a Bachelor’s degree with 0-2 years in a GMP-regulated environment, plus strong attention to detail,