Job Description

The Stability Coordinator is responsible for the smooth tracking and operation of all stability studies on site. This job requires the ability to demonstrate a high commitment to interpersonal relations. The Stability Coordinator works closely with Chemistry, Microbiology, and Client Services Department Management. This position presents the employee with an opportunity to play a key role in stability studies which includes Study Management, sample pulls, sample/study initiation, Regulatory Compliance, and Data Management while simultaneously learning the technical skills required to advance in the field of stability studies.

• Performs a variety of activities to help administer the stability program at SGS Life Science Services
• Responds to customer requests for information concerning stability studies
• Assists in the preparation of stability protocols and final reports
• Performs any needed stability trending as outlined in the stability protocol
• Stability Protocol and Report writing
• Ability to write deviations, OOS and CAPA
• Prepares samples for inclusion in stability studies, including labeling and distribution to the appropriate stability chamber
• Removes samples from stability chambers according to protocol pull schedules and submits them to the appropriate testing group or outside customer
• Maintains stability chamber inventory and monitors chamber performance
• Utilizes LabVantage LIMS to manage and track studies to completion
• Perform a quarterly inventory of stability samples, with special attention to control samples
• Maintain thorough knowledge and understanding of all Standard Operating procedures (SOPs) pertaining to testing, review, and equipment calibration and maintenance
• Maintain thorough knowledge and understanding of general SOPs, GMP/GLP, and ISO regulations as it pertains to work performed in the laboratory
• Maintain knowledge of current compendia and testing methods as they apply to stability studies and knowledge of FDA guidelines regarding stability requirements
• Able to work with minimal guidance to take a project from start to finish
• Adherence to relevant SOPs governing documentation
• Participation in general staff meetings and training sessions as scheduled by Client Services Management

Qualifications

• Associate's degree in a scientific field or equivalent job experience required
• 5+ years of relevant laboratory experience in an FDA regulated environment with pharmaceutical stability programs and processes, knowledge of cGMPs
• Bachelor's degree in a scientific field preferred

Additional Information

SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.

This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company’s rights to assign or reassign duties and responsibilities to this job at any time.

If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.