Pharmaceutical Manufacturing Associate

NCC Talent Solutions, LLC; San Diego (CA); Vor Ort; USD 60.000 - 85.000; Vollzeit

Zusammenfassung

NCC Talent Solutions partners with a Contract Manufacturing Organization in San Diego to scale up their manufacturing team for sterile drug product manufacturing in a GMP cleanroom environment. We seek multiple Manufacturing Associates (level based on experience) to support aseptic fill & finish operations and related GMP activities.

You will execute batch production records, follow SOPs, perform aseptic fill and finish activities, and help maintain equipment and cleanroom operations while

Qualifikationen

• Bachelor's degree in Life Science preferred; experience considered.
• 37+ years in GMP-regulated pharma/biotech environments.
• Experience in aseptic processing and cleanroom gowning.
• Ability to read batch records and SOPs.
• Able to lift up to 50 pounds and wear cleanroom PPE for extended periods.

Aufgaben

• Execute batch production records and follow SOPs for sterile manufacturing.
• Perform aseptic fill and finish activities in GMP cleanroom.
• Operate, maintain filling and production equipment.
• Conduct environmental monitoring and in-process checks.
• Complete GMP documentation and batch records accurately.
• Support cleanroom stocking, validation activities, CAPA input.

Kenntnisse

Aseptic processing

Cleanroom gowning

Batch records

SOP adherence

Ausbildung

Bachelor0s degree in Life Science

Tools

GMP equipment

Jobbeschreibung

Relocation assistance is not provided for this role. Candidates must be able to work from the listed location without relocation support.

Type:Full-Time - Direct Hire

Industry:Pharmaceutical / Biotech (GMP)

Role Overview

NCC Talent Solutionsis partnering with aContract Manufacturing Organizationin San Diego to scale up their manufacturing team to support a growing GMP operation. We are seeking multiple Manufacturing Associates (level based on experience)to support sterile drug product manufacturing within a GMP-regulated cleanroom environment.

This role is responsible for executingaseptic fill & finish operations, supporting cleanroom maintenance, and ensuring all production activities meet the highest standards of quality and compliance.

How you will make an impact:

• Executebatch production recordsand follow all SOPs for sterile manufacturing operations
• Performaseptic fill & finish activitiesin a GMP cleanroom environment
• Operate and maintainfilling and production equipment
• Performfilter integrity testingand in-process checks
• Conductvisual inspection of filled vialsfor quality and compliance
• Performenvironmental monitoring(viable and non-viable)
• Support stocking and inventory of cleanroom and production supplies
• Assist withcleanroom and equipment validation activities
• Accurately complete all GMP documentation and batch records
• Participate inmedia fillsand aseptic process qualifications
• Assist in drafting and updatingSOPs and Master Batch Records
• Provide input forCAPA investigationsrelated to deviations, sterility failures, and non-conforming materials

The experience you will bring:

• Bachelor’s degree in Life Science highly preferred. Experience will be considered in lieu of education.
• Typically requires 3–7+ yearsof experience in GMP-regulated pharmaceutical or biotech environments with experience executing activities in an aseptic manufacturing environments. Experience in drug product/drug substance manufacturing preferred.
• Hands-on experience withaseptic processing and cleanroom gowning
• Strong ability toread, interpret, and execute batch records and SOPs
• Ability to interpret technical instructions, including diagrams and procedures
• Ability to lift up to50 pounds
• Ability to wearcleanroom PPE and gowning(including goggles, face shields, respirators, gloves) for extended periods (up to 4 hours at a time)
• Comfortable working in acontrolled cleanroom environmentfor the majority of the workday