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Stability Coordinator (Closed)

Date Posted: 2/17/2020

Job #1571115
Permanent
Charlotte, North Carolina
Staff

Accountabilities and Responsibilities:

  • Maintaining a compliant stability program meeting regulatory and customer needs and expectations.
  • Project management with regard to stability sample testing, completion and using influence strategies to drive testing completion without direct authority over testing groups.
  • Owning responsibility for timely data acquisition of stability samples.
  • Generating stability protocols, interpreting stability trend results and writing interim or final stability reports as appropriate.
  • Provide project updates to supervision, client, and project teams.
  • Monitoring, maintaining and qualifying stability environmental chambers.
  • Coordinate and oversee outside testing for stability samples.
  • Assisting with training of stability personnel.

Requirements:

  • BS degree in Chemistry or a related field, with a minimum of three years of pharmaceutical experience in a cGMP environment and/or Quality Control analysis experience preferred
  • Experience operating and maintaining analytical instrumentation including HPLC, GC, FTIR, UV-vis, KF, AA automated titrators and/or chromatography data collection systems is required
  • Experience with management of or working knowledge of stability programs is beneficial
  • Excellent written and verbal communications skills; the ability to present ideas to management
  • Computer knowledge including word processing, spreadsheets, chemical structure drawings, and database management is required