Stability Coordinator

  • location: Allentown, PA
  • type: Permanent
  • salary: $55,000 - $60,000 per year
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job description

Stability Coordinator

job summary:
Seeking a Stability Coordinator to assist Stability Manager in stability operations activities to help ensure quality products and systems. Activities to include: assisting with protocol development and execution, track testing status, internal and external testing coordination, scheduling, stability testing release, regulatory data compilation for submissions and audits, report generation for completed protocols, annual reports, investigations, and CAPAs.

 
location: Allentown, Pennsylvania
job type: Permanent
salary: $55,000 - 60,000 per year
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Help Coordinate stability operation activities and ensure quality products and systems
  • Develop stability protocols
  • Build, review and approve Studies in LIMS
  • Conduct Year-End controlled substance inventory of environmental chambers for annual DEA report
  • Review submitted samples for testing according to stability protocol and/or product specifications
  • Approve stability data on graphs and spreadsheets to verify product shelf life and estimate expiration
  • Release stability data
  • Work closely with laboratory personnel and/or team leader regarding work scheduling and assignments
 
qualifications:
  • Bachelor's degree in pharmacy, chemistry or related scientific field with 3-5 years of pharmaceutical GMP experience
  • Must be proficient in Microsoft Office and other software using a personal computer
  • Requires intermediate to advanced Excel skills
  • Knowledge of and ability to work with equipment, supplies, components and technical areas that are utilized in the pharmaceutical industry, i.e., weighing equipment and controlled environmental chambers
  • Knowledge of FDA guidelines on Stability requirements is a plus
  • Quality minded with ability to perform work with detailed accuracy and in accordance with established procedures
 
skills: Chemistry
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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