Stability Study Coordinator
3 months ago
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.
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