PLS QA Specialist II

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

This is a full-time QA Specialist II position located in Lebanon, NJ, from Monday - Friday, 8:00 a.m. to 5:00 p.m.

Primary Responsibilities:

• Responsible for assuring that all quality-related records generated by the company adhere to a strict review process ensuring the integrity of the final report of analysis following all regulatory and company standards.
• Support laboratory activities that require Quality Assurance involvement.
• Assist Management in client communication, client questionnaires and approval of lab equipment activities (IQ, OQ, PQ, PV, PM and calibration documents)
• Prepares or assists in writing, reviewing, approving, and implementing standard operating procedures (SOPs)
• Initiate and review proper change control, deviation, out-of-specification, and investigation documentation when required
• Review of instrument qualification and analytical method validation protocols and reports
• Update pertinent logs and tracking systems as they relate to the company's Quality Systems Document Control
• Other duties and responsibilities may be required as needed

Desired Skills:

• A Bachelor's degree in Chemistry or other science-related disciplines.
• Previous experience (3-6 years) working in a Pharmaceutical QA environment.
• Knowledge of various regulatory systems and guidelines is ideal (FDA and EU, cGMP, etc.)
• Must be detail-oriented, organized, and possess the ability to be flexible to meet the needs of technical employees across multiple departments
• Ability to work independently or as part of a team
• Must possess strong interpersonal skills and have the proven ability to communicate with employees/customers/clients in both oral and written form, fluent in the English language
• Willingness to learn and expand their knowledge and technical expertise in a fast-paced environment
• Strong computer skills; emphasis on Microsoft Excel and Word

Physical/Mental Requirements:

The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Mobility to work in a lab and office setting, use standard office and lab equipment and stamina to sit for extended periods of time; exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to lift, carry, push, pull or move objects; vision to read printed materials and computer screens; and hearing and speech to communicate in person or over the telephone.

Working Environment:

Work is performed in a lab and office setting. Work is subject to chemicals, fumes, gases, noxious odors, and related items in a lab setting.