Pharma QA Specialist II — Quality Assurance & Compliance

RXinsider LTD.; Lebanon (NJ); On-site; USD 65,000 - 90,000; Full time

Job summary

RXinsider LTD. is seeking a full-time QA Specialist II in Lebanon, NJ, working Monday to Friday, 8:00 a.m. to 5:00 p.m. The role focuses on ensuring quality records meet regulatory and company standards, and supporting laboratory QA activities.

The ideal candidate has a Bachelor's degree in Chemistry or related science and 3–6 years of pharmaceutical QA experience, with knowledge of FDA/EU cGMP guidelines. Strong communication in English and attention to detail are essential.

Qualifications

• Bachelor’s degree in Chemistry or related science.
• 3–6 years of experience in a Pharmaceutical QA environment.
• Familiar with FDA and EU cGMP guidelines.
• Detail-oriented, organized, and able to work across departments.
• Excellent written and verbal English communication.

Responsibilities

• Ensure QA records comply with regulatory and company standards.
• Support laboratory activities requiring QA involvement.
• Assist management with client communications and documentation.
• Review SOPs and implement changes.
• Initiate and review change control, deviations, and investigations.
• Review instrument qualification and method validation protocols.
• Update logs and tracking systems for Quality Systems.
• Perform additional duties as needed.

Skills

QA in pharma

Regulatory knowledge

Attention to detail

Communication skills

English fluency

Education

Bachelor's degree in Chemistry or related science

Tools

Microsoft Excel

Microsoft Word

Job description

RXinsider LTD. is seeking a full-time QA Specialist II in Lebanon, NJ, working Monday to Friday, 8:00 a.m. to 5:00 p.m. The role focuses on ensuring quality records meet regulatory and company standards, and supporting laboratory QA activities.

The ideal candidate has a Bachelor's degree in Chemistry or related science and 3–6 years of pharmaceutical QA experience, with knowledge of FDA/EU cGMP guidelines. Strong communication in English and attention to detail are essential.