QA Associate

Integrated Resources Inc.; East Windsor Township (NJ); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading staffing firm is seeking a Quality Assurance professional in East Windsor Township. This role involves creating quality systems, conducting reviews, and ensuring compliance with FDA regulations. Ideal candidates will have a BS in a relevant field and experience in QA within the pharmaceutical industry, with strong communication skills.

Qualifications

• 1-5 years of QA/validation experience in an FDA-regulated industry.
• Familiarity with solid dosage pharmaceutical manufacturing processes.
• Thorough understanding of GMP.

Responsibilities

• Create and establish a scientific approach to the company quality system.
• Perform review and release of API and excipients.
• Provide guidance and training to other QA staff.

Skills

Technical writing

Communication

Quality assurance

Education

BS degree in Chemistry, Life Sciences, or related discipline

Job description

A Few Words About Us
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy, and Nursing.

Job Description

We are seeking a Quality Assurance professional to:

1. Create and establish a scientific approach to the company quality system.
2. Perform review and release of API and excipients in support of manufacturing.
3. Establish training and audit programs, review SOPs, investigations, specifications, methods, validation reports, cleaning verification reports, analytical reports, and manufacturing records.
4. Review and approve Master documents such as Master Batch Records, In-process forms, Method Qualification Protocols, Method Validation Protocols, test methods, reference standards, and related documents.
5. Provide guidance and training to other QA staff in quality assurance activities.
6. Represent the company during regulatory inspections and customer audits.

Qualifications

• BS degree in Chemistry, Life Sciences, or a related discipline with 1-5 years of QA/validation experience in an FDA-regulated industry.

• Familiarity with solid dosage pharmaceutical manufacturing processes and thorough understanding of GMP.

• Strong technical writing skills and the ability to communicate clearly in English.