Manufacturing Quality Specialist

The Manufacturing Quality Specialist is responsible for ensuring compliance with cGMP regulations, company policies, and customer expectations by supporting manufacturing operations through documentation review, quality event management, and process oversight. This role requires expertise in upstream and downstream biologics processes, quality systems, and regulatory requirements to ensure the highest standards of product quality and compliance.

Location: Piscataway, New Jersey

Shift: Mon-Fri, 9-5

Salary: $90,000 -$100,000 experience depending

Responsibilities:

• Perform inspection, sampling, and testing (where applicable) on incoming materials, packaging components, and returned goods following detailed written procedures.
• Ensure smooth flow of raw material and critical material testing through routine follow-up with internal and external laboratories.
• Perform...

The Manufacturing Quality Specialist is responsible for ensuring compliance with cGMP regulations, company policies, and customer expectations by supporting manufacturing operations through documentation review, quality event management, and process oversight. This role requires expertise in upstream and downstream biologics processes, quality systems, and regulatory requirements to ensure the highest standards of product quality and compliance.

Responsibilities:

• Perform inspection, sampling, and testing (where applicable) on incoming materials, packaging components, and returned goods following detailed written procedures.
• Ensure smooth flow of raw material and critical material testing through routine follow-up with internal and external laboratories.
• Perform cleaning and sanitization of ISO 7 areas and ISO 5 laminar flow hoods per written procedures.
• Assign and verify expiry dates and retest dates for all GMP raw...

At Tata Consumer Products Ltd, we stand #Forbetter – Planet, Sourcing, Nutrition, Communities. And #ForBetter Opportunities …. Here’s an exciting one!

Quality Assurance Specialist | Landover, MD | On-Site | Non-Exempt FTE

How does this Job align to our Strategy?

We are seeking a driven and talented individual to play a critical role in leading compliance and continuous improvement projects within the Quality function. This individual will directly be responsible for assuring and enabling the compliance and continuous improvement of all product materials, manufacturing processes and finished products including the supporting systems and processes and the operating environment. The person will be responsible to identify opportunities and lead improvement efforts working cross-functionally with Production, Maintenance, New Product Development, and Supply Chain teams with support from Quality Supervisor.

This...

Manufacturing QMS Specialist who will be responsible for writing and reviewing deviations, change controls, investigation reports, batch records, SOPs, CAPA etc. This position requires technical expertise in upstream and downstream process of biologics (Cytokines, monoclonal antibodies manufacturing).

Responsibilities:

• Responsible to support manufacturing team with all kinds of documentation.
• Documentation includes reviewing executed batch records (both Upstream department and Downstream batch record).
• Responsible for filing change controls, deviation, CAPA for manufacturing department.
• For all critical / major investigation, will have to use investigation tools like 5why or 6M method.
• Attend daily meetings with both upstream and downstream process to get all the documentation requirement for the day.
• Meet weekly with QA to avoid any delay in the QMS closure.
• Author batch records, SOPs and...