QA Associate II

System One; Mahwah (NJ); On-site; USD 50,000 - 80,000; Full time

Job summary

An established industry player is seeking a Quality Assurance Associate II to join their team in the Mahwah area. This pivotal role involves supporting essential quality systems and ensuring compliance with FDA regulations in a biotechnology setting. You'll be responsible for reviewing batch records, quality control data, and facilitating material releases, all while maintaining the highest standards of quality. If you have a scientific background and a passion for quality assurance, this position offers a fantastic opportunity to grow within a supportive environment that values compliance and continuous improvement.

Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Life Insurance

Voluntary Plans

Qualifications

• 1-3 years experience in biologics or biotechnology.
• Strong understanding of GMP and TCTP regulations.

Responsibilities

• Support daily tasks for maintaining quality systems.
• Review manufacturing batch records and QC data.
• Ensure compliance with FDA and quality regulations.

Skills

Quality Control Data Review

Batch Record Review

Aseptic Manufacturing Knowledge

GMP and cGMP Compliance

Biotechnology Experience

Education

BS or higher in a scientifically related field

Tools

ERP System

Job description

Job Title: Quality Assurance Associate II
Location: Mahwah, NJ area
Schedule: Tues- Saturday 2nd shift 4 PM- 12:30 AM (some flex needed)
Type: Contract to Hire

Must Haves:

• BS or higher education degree in a scientifically related field
• Experience in a biologics or biotechnology company (1-3 years)
• Working knowledge and technical understanding of the aseptic manufacture of biologics preferred
• Experience with batch record review in a biotechnology manufacturing environment.
• Experience reviewing QC data in a biotechnology manufacturing environment
• Working knowledge of GMP and TCTP regulations
• Experience in reviewing GMP/GCTP related documents (validations/qualifications reports, SOPs, etc)

Responsibilities:

• Under direct supervision, the associate supports daily tasks that are essential for maintaining and improving quality systems and adhering to client-specific procedures.
• Key responsibilities include document management, review of manufacturing batch records, quality control (QC) data, facilitating material releases, overseeing final product releases, and providing essential assistance to the Quality Management as needed.
• Ensures that all procedures and processes meet internal quality standards as well as external regulations specific to pre-clinical, clinical and commercial manufacturing.
• Read, understand and follow all cGMP and cGTP documentation for Quality System Functions (SOPs, WIs, etc.)
• Maintain cGMP and cGTP compliance for all aspects of pre-clinical, clinical and commercial manufacturing.
• Release raw material in ERP system as well as on paper.
• Perform Accessioning of incoming Apheresis.
• Review Batch record and disposition material of finished product to client.
• Provides information for Out of Specification and deviations to investigator.
• Performs line clearance prior to manufacturing operations begins.
• Supports tech transfer activities.
• Other duties as assigned.
• Build Quality into all aspects of your work by maintaining compliance to all quality requirements.
• Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
• Attend all required Quality & Compliance training at the specified interval.

Benefits:

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.