Stability Study Coordinator

 

Company Description

WE ARE SGS – THE WORLD’S LEADING TESTING, INSPECTION AND CERTIFICATION COMPANY. WE ARE RECOGNIZED AS THE GLOBAL BENCHMARK FOR QUALITY AND INTEGRITY. OUR 89,000 EMPLOYEES OPERATE A NETWORK OF 2,600 OFFICES AND LABORATORIES, WORKING TOGETHER TO ENABLE A BETTER, SAFER AND MORE INTERCONNECTED WORLD.

Job Description

• Perform all tasks according to SGS SOP for stability unless requested by client to do otherwise. Place them in appropriate storage areas. Prepare stability programs in LIMS; Label samples with stability Study number.
• Have inventory available for all stability programs from start to finish. Perform it at least annually.
• Communicate effectively with clients for the purpose of getting protocols approved by client.
• Inform laboratory supervision at least one week before pulling so it can be scheduled and completed on time.
• Pull samples for testing within timeframe according to SGS SOP or client request.
• Where deviations from environmental conditions happen participates in investigations and resolution and communication to client for justifications of testing results.
• Summarize stability points and results.
• Inform supervisor of any barrier to complete any of the tasks; Communicate with clients regarding specifications, optional pull/testing conformation or sample disposal/shipment.
• Perform inventory stability samples; Disposal remaining samples or send back to client when study is completed.
• Revise stability SOP if required or when regulatory guidelines change

Qualifications

• Bachelor of Science degree in Chemistry, Biochemistry, Biology, Microbiology or College with minimum 10 years related experience.
• Knowledge of ICH guidance for stability of products and how to set stability in LIMS.
• Strong drive to deliver quality results to clients on time.
• Thorough knowledge of scientific principles pertaining to analytical records review.
• Works well under pressure.

Additional Information

SGS Canada is an equal opportunity employer and we are committed to achieving greater accessibility by providing accommodation for people with disabilities during our hiring process. Accommodations are available on request for qualified candidates during each stage of the recruitment process.

Please note that candidates applying for Canadian job openings should be authorized to work in Canada.