QA Associate

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 is a third-party testing lab located in New Brunswick, NJ supporting pharmaceutical, nutraceutical, supplement, and cosmetic industries.

Seeking an experienced QA Associate to join our team to support the activities of the Quality Assurance Department in a testing laboratory environment.

The QA department is responsible for the quality management system and therefore this role is critical to ensure quality procedures are being implemented.

This role must have a solid understanding of GMP requirements and follow New Jersey Laboratories Quality Manual, Standard Operating Procedures, and any applicable compendia methods.

NJ Labs is a fast-paced environment where analysis and priorities are constantly changing based on client requirements.

Role And Responsibilities

• Required to adjust workload based upon changing priorities.
• Able to adapt to changes with the company’s policies and regulations.
• Work as a team: Departmental collaboration to achieve a common goal or to complete a task in the most effective and efficient manner
• To accommodate business needs, which includes understanding how to prioritize daily tasks and be efficient with managing time.
• Provide daily tasks performed to the departmental QA Manager.
• Provide support during client and regulatory Audits and/or participate in Audits. Prepare/issue audit reports.
• Reviewing a variety of analytical chemistry and microbiology test analyses such as HPLC, GC, UV-VIS, ICPMS, HPTLC, Wet Chemistry Analyses, TAMC, TYMC, E.coli, Staph, Pseud, Endotoxins, Sterility, etc. Ensuring the test is performed as per the method used.
• After reviewing analyses, responsible for identifying and communication errors found in the review documentation to analysts and management.
• Write and/or review verifications/validations, as applicable.
• Write and/or review SOPs, deviations, OOSes, CAPA, and Change Controls as applicable. This may include any other GMP controlled documents.
• Must be able to maintain the SOP review schedule.
• Responsible for maintaining the laboratory notebook log and issuance of laboratory notebooks.
• Responsible for maintaining the deviations, OOSes, Change Control and CAPAs to ensure it is closed out in a timely manner.
• Responsible for maintaining and controlling the controlled substance inventory.
• Responsible for maintaining training documents of all employees and ensures all employees are appropriately on boarded as per standard operating procedures.
• Able to perform a risk assessment analysis and implement detailed improvement plans.
• Provide support to investigations and identify gaps within existing quality system and propose and implement solutions for functional management.
• Recommend remediation actions and follow up on implementation of the plan.
• Supports resolution of technical and compliance issues/gap analysis.
• Provide ongoing training on relevant topics and QA procedures.
• Actively engage in the training of staff with less experience or knowledge of quality assurance processes.
• Confirm standard operating procedures are being adhered to, taking corrective actions when non-conformances are observed.
• Good documentation practice.
• Maintaining the inventory, calibration, and preventative maintenance of equipment which also includes scheduling calibration via third party vendor.
• Work in coordination with the regulatory affairs group in support of ANDA submissions.
• Requires communicating with clients in a professional manner to convey any quality impacts or events.
• May require keeping clients informed on quality statuses and review.
• Other duties as assigned.

Qualifications And Experience

• 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.
• Demonstrates a good understanding of United States Pharmacopeia testing procedures and methodology.
• Attention to detail and excellent communication skills are also a must!
• Experience in a cGMP environment.
• Discretion
• Ability to work independently and collaborate on team projects.
• Computer competency with experience in Microsoft Office Suite.
• Must have writing skills!
• Problem Solving Skills.

Work Conditions And Physical Requirements

• Wear proper protective equipment where necessary,
• Sometimes exposed to loud sounds or distracting noise levels.
• Are often exposed to contaminants or hazardous conditions while conducting analyses.
• Work within several feet of others in the laboratory.
• Sit or stand for an extended period.
• Be able to lift objects up to 25 pounds.
• May have to crawl or climb when reviewing/auditing the laboratory.
• Repetitive tasks with few breaks.

We Offer and Work Environment

• Generous benefit options
• Paid training, vacation, and holidays (vacation accrual begins on first day of employment)
• 401k program
• Learning platform
• And more!

Salary Range: $50,000-$60,000/year

Note: The Company will explore and provide reasonable accommodations to assist any qualified individual with a disability in performing the essential functions of his/her job.