Stability and Study Coordinator

Consumer Product Testing Company; Fairfield (NJ, CA); On-site; USD 50,000 - 80,000; Full time

Job summary

An established industry player is seeking a Stability and Study Coordinator to join their dynamic team. This role is pivotal in ensuring the integrity and compliance of product testing within a GMP-regulated environment. The ideal candidate will have a strong background in analytical chemistry and stability systems, coupled with excellent communication and organizational skills. You'll be responsible for coordinating stability studies, preparing detailed protocols, and collaborating closely with clients and internal teams. If you're passionate about quality assurance in product testing and thrive in a fast-paced environment, this opportunity is perfect for you.

Qualifications

• Minimum 2 years stability systems experience in a GMP environment.
• Strong communication skills with attention to detail.

Responsibilities

• Communicates with clients regarding studies to ensure timely processing.
• Entry of stability studies into company software system.
• Develops stability study protocols according to customer requirements.

Skills

Stability Systems Experience

Analytical Chemistry

GMP Laboratory Experience

Technical Writing

Communication Skills

Organizational Skills

Education

Bachelor's Degree in Chemistry

Tools

Microsoft Office

Company Software System

Job description

One of the nation's largest independent testing facilities seeks a Stability and Study Coordinator with a minimum of 2 years stability systems experience in a GMP environment. The perfect candidate will also have previous experience as an Analytical Chemist with a minimum 2 years experience testing products for the pharmaceutical, nutritional cosmetic, personal care, medical device or allied industries. The position requires a working knowledge of testing products in a GMP regulated facility. Must have the technical ability to understand client requirements, technical documentation, and be able to prepare testing protocols.



Responsibilities include, but are not limited to the following:

• Communicates with clients regarding studies to ensure timely processing and submission to the laboratories.


• Entry of stability studies and all associated information into company software system and communicates the stability testing schedules to department management.


• Performs time point pulls within the acceptable guidelines and documents details as per SOPs, customer and regulatory requirements.


• Submission of the stability samples to the appropriate departments.


• Develops and generates stability study protocols according to customer requirements and timelines, internal SOPs and regulatory requirements.


• Compilation of time point raw data and verification of results entry into stability system as well as generation of interim and summary time point data and reports.


• Prepares the generation of shelf life summary reports for products based on compiled data.


• Coordinates with department management regarding stability workload and schedules to ensure timelines are met.


• Preparation of sample shipments and paperwork for returned samples.


• Entry of routine, development and validation studies and all associated information into company software system and communicates the study details to department management.


• Documents work clearly and accurately.


• Perform technical writing and peer review as needed


• Capable of working in a fast paced environment.

Education and Experience

• Bachelor's degree in chemistry or other related degree, preferred.


• Minimum 2 years of stability systems experience in a GMP laboratory.


• Minimum 2 years of product testing experience in a GMP laboratory.


• ISO 17025 experience a plus.


• Excellent scientific and organizational skills.


• Strong communication skills (written and oral) with an attention to detail.


• Ability to learn new techniques, multitask, follow instructions and comply with SOPs.


• Self motivated and have the ability to work independently and as part of a team.


• Authorization to work in the United States indefinitely without restriction or sponsorship.

Physical Requirements and Working Conditions:

• Ability to stand/sit in office and laboratory environment.


• Ability to use a personal computer and Microsoft Office (Word, Excel, Outlook) experience required.


• Vision accuracy and color detection are required for this position


• Ability to wear/use personal protective equipment as required such as lab coat, goggles, gloves, masks, etc.


• Ability to lift up to 30 lbs.