Stability Coordinator

?SGS is the world?s leading inspection,verification, testing and certification company. SGS is recognized as theglobal benchmark for quality and integrity. With more than 95,000 employees,SGS operates a network of over 2,400 offices and laboratories around theworld.?


The Stability Coordinator performs avariety of activities to help administer the stability program at SGS LifeScience Services

?Job Duties:

????????Responds to customer requests forinformation concerning stability studies

????????Assists in the preparation ofstability protocols and final reports

????????Performs any needed stabilitytrending as outlined in the stability protocol

????????Stability Protocol and ReportWriting

????????Ability to write deviations, OOS andCAPA

  • 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 quarterly inventory of stability 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 requirement
  • 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

  • Bachelor?s Degree required ?
  • 5 years of laboratory experience in a regulated environment such as; a pharmaceutical stability program
  • Previous cGMPs in an FDA experience regulated environment
  • Must have Microsoft Office and database software skills
??Physical Demands:?
  • Job requires mobile use of hands and arms
  • The employee must occasionally lift and/or move up to 25 pounds
  • Specific vision abilities required by this job include close vision and ability to adjust focus
  • While performing the duties of this job, the employee is frequently required to stand, walk and sit
  • Reasonable accommodations will be made for persons with disabilities?

"SGSis an Equal Opportunity Employer, and as such we recruit, hire, train, andpromote persons in all job classifications without regard to race, color,religion, sex, national origin, disability, age, marital status, citizenstatus, sexual orientation, genetics, status as a protected veteran, or anyother non-job-related characteristics."


"Thisposition is responsible to ensure equal opportunity in employment in that allpersons are treated equally and on the basis of merit, in decisions regardingselection, placement, promotions, training, work assignments, transfers andother personnel action?.


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