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
