Stability Studies Coordinator
Stability Studies Coordinator
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Not Disclosed
Salary Not Disclosed
1 Vacancy
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.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
