Regulatory Affairs Associate

New Jersey Laboratories
New Brunswick, NJ

Benefits Offered

Dental, Medical, Vision

Employment Type

Full-Time

Why Work Here?

“Great CEO, friendly collegial environment focused on quality, opportunity for growth testing across various industries. You won’t be bored!”

Job Overview

The Regulatory Affairs Associate will report to Quality and Regulatory Affairs Manager and is responsible for ensuring that New Jersey Laboratories follows all pertinent government regulations. The incumbent will work independently and within a group setting to act as liaison between quality departments as well as external clients and vendors. This individual will have a solid understanding of FDA regulations, ICH guidelines and internal quality procedures. The ideal candidate will have excellent written and effective verbal communication skills, proficient in project management, is flexible, and able to work in a fast-paced environment. Understanding of GMP, GDP, USP chapters, and other applicable regulatory guidance and requirements are important.

Role and Responsibilities

  • Write and review method validation and verification protocols and reports.
  • Write and review Standard Operating Procedures and ensure compliance with current regulatory requirements.
  • Manage change controls documentation and risk assessment meetings.
  • Responsible for reviewing and/or writing instrument qualifications and calibrations.
  • Assist in conducting internal audits.
  • Assist in conducting client audits and regulatory agency audits.
  • Responsible for conducting onsite supplier audits, qualify suppliers and write and review audit letter responses.
  • Responsible for responding to quality questionnaires and maintain quality agreements.
  • Maintain the training program, ensuring proper training and periodic/yearly trainings.
  • Maintain registrations with FDA, DEA, and other applicable regulatory bodies.
  • Oversee the pest control program and all pest-related issues.
  • Perform notebook review, as required.
  • Maintain Quality Agreements and ensuring that NJ Labs follows all Quality requirements of clients.
  • Recommend changes to the company procedures in response to changes in regulations or standards.
  • Responsible for keeping abreast with FDA and DEA regulations.
  • Read and understand guidance documents, ICH quality documents, ISO quality documents, and 21 CFR regulations pertinent to the pharmaceutical, dietary supplements, and cosmetics industries.
  • To accommodate business needs, which includes understanding how to prioritize daily tasks and be efficient with managing your time.

The position includes all other responsibilities that may be necessary to fulfill the duties associated with the position or as may be assigned.

QUALIFICATIONS

  • BS degree in Life Sciences, Regulatory Affairs, Pharmacy/Pharmaceutical Sciences, or related field.
  • At least two (2) years of experience in the pharmaceutical industry.
  • Ability to work independently, prioritize multiple projects, address multiple issues, and handle multiple deadlines.
  • High degree of initiative and solid decision-making skills.
  • Ability to adapt quickly to changing regulations.
  • Computer competency with experience in Microsoft Office Suite.
  • Excellent analytical, written, and verbal communication skills.
  • Authorized to work in the U.S. of America.

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.

WORKING CONDITIONS

This position must work a minimum of 40 hours a week over a period of 5 days a week and may require additional hours to meet project deadlines. This position does not require traveling.

· Wear proper protective equipment.
· 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 to perform certain tasks like maintenance of an instrument.
· Repetitive tasks with few breaks.

DIRECT REPORTS

This position has no supervisory responsibilities.

About NJ Labs:

NJ Labs provides expert analytical chemistry & microbiology testing for the pharmaceutical, nutraceutical, dietary supplement, cosmetic, dairy & food industries. We are an FDA, DEA, registered & inspected, contract laboratory testing to exacting CGMP standards. Our team of scientists builds upon our quality legacy by continually developing and validating methods for raw materials and finished products testing – established upon our founding over 80 years ago.

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