Tech Jobs for Talents without Borders
English-1st. Relocation-friendly. Curated daily by Imagine.
4,833 Jobs at 194 Companies

QA Operations Specialist- 2nd Shift



Operations, Quality Assurance
United States
Posted on Thursday, September 28, 2023

Job Description

Quality Assurance(QA) Operations Specialist- 2nd shift

Location: Millburn, NJ #LI-Onsite

About this role:

This is an exciting opportunity to join our Quality Assurance Team as a QA Operations Specialist. You will be responsible for quality assurance oversight of manufacturing, testing and supply chain operations with current GMP regulations, procedures and quality systems.

Key Responsibilities:

• Provide shop floor quality oversight of all production, quality control and supply chain departments to ensure their practice fully adheres to cGMP, including data integrity. Ensure timely escalation to management of all applicable incidents.
• Perform live review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately.
• Assist functional areas with achieving timely and compliant final product disposition of the product.
• Review, approve and support procedures and production/testing records as required and assist in the training of site associates.
• Ensure compliance of site personnel and application of aseptic techniques and full compliance to sterile manufacturing regulations.
• Support FDA/Regulatory interactions for the site activities and products to ensure successful regulatory submissions and inspections.
• Support QA Operations as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance and data integrity.

Additional Specifications
• This position involves shift work which will be defined through site start up and commercialization readiness.
• This position involves on-call shifts, if required, when scheduled.

NOTE: This is a 2nd shift position either Sun-Wed or Wed-Sat