QA Associate - GMP Lab Compliance & Audits

NJ Labs; New Brunswick (NJ); On-site; USD 50,000 - 60,000; Full time

Benefits offered by this job

Generous benefits options

Paid training, vacation and holidays

401k program

Learning platform

And more!

Job summary

NJ Labs in New Brunswick, NJ is seeking an experienced QA Associate to support the Quality Assurance Department in a fast-paced testing laboratory. The role focuses on maintaining GMP-compliant quality systems, reviewing test analyses (HPLC, GC, UV-VIS, ICPMS, endotoxins, sterility), and contributing to SOPs, deviations, CAPAs, and change controls.

The successful candidate will work with analytical chemistry and microbiology methods, assist audits, train staff, and ensure accurate documentation

Qualifications

• Bachelor’s degree (or equivalent experience) in chemistry or a related scientific field.
• Minimum two (2) years of experience in the pharmaceutical/nutraceutical/dietary industry.
• Good understanding of United States Pharmacopeia testing procedures and methodology.
• Attention to detail and excellent communication skills.
• Experience in a cGMP environment.
• Ability to work independently and collaboratively on team projects.
• Proficient in Microsoft Office; strong writing skills.
• Problem solving skills.

Responsibilities

• Adjust workload based on changing priorities.
• Adapt to changes with company policies and regulations.
• Collaborate within the department to achieve goals.
• Prioritize daily tasks and manage time efficiently.
• Provide daily tasks to QA Manager.
• Support during client and regulatory audits and/or participate in audits; prepare/issue audit reports.
• Review analytical test analyses (e.g., HPLC, GC, UV-VIS, ICPMS, endotoxins, sterility).
• Identify and communicate errors in review documentation.
• Write/review verifications, validations, SOPs, deviations, OOSes, CAPA, and change controls.
• Maintain SOP review schedule and laboratory notebooks; manage deviations and CAPAs.
• Maintain controlled substance inventory and training documents.
• Perform risk assessments and implement improvement plans.
• Support investigations and QA process gaps; propose solutions.
• Provide ongoing QA training and staff development.
• Ensure SOP adherence and take corrective actions for non-conformances.
• Maintain calibration and preventive maintenance of equipment; coordinate with vendors.
• Coordinate with regulatory affairs on ANDA submissions.
• Communicate quality statuses to clients professionally; keep them informed.

Skills

Attention to detail

Excellent communication

Problem solving

Independent work

Team collaboration

Microsoft Office

Documentation skills

Education

Bachelor’s degree in chemistry or related

Equivalent experience

Job description

NJ Labs in New Brunswick, NJ is seeking an experienced QA Associate to support the Quality Assurance Department in a fast-paced testing laboratory. The role focuses on maintaining GMP-compliant quality systems, reviewing test analyses (HPLC, GC, UV-VIS, ICPMS, endotoxins, sterility), and contributing to SOPs, deviations, CAPAs, and change controls.

The successful candidate will work with analytical chemistry and microbiology methods, assist audits, train staff, and ensure accurate documentation