Stability Coordinator
SGS North America Inc.

Job Info

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Company Description

SGS is the world's leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 89,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.

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.

Job Functions

• 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
• Adherence to applicable SGS personnel policies regarding time clock, telephones, sick days, vacation days, etc.
• 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

This job has expired.