Wayne Metro Area, NJ
Responsible for the administration of the stability programs and authoring Annual Stability Reports for US marketed products.
Stability Study Administration Responsibilities:
Ensures that all batches due to be placed on stability are received, accurately initiated with regard to quantity of samples, appropriate storage conditions per protocol and accurate time point pull schedule
Assumes responsibility to ensure the stability assessments associated with change controls are successfully implemented
Ensures that stability related follow-up corrective actions are completed
Writes stability protocols and stability reports
Represents the stability group on cross functional teams as necessary
Maintains the stability environmental chambers and ensures timely destruction of excess material associated with completed stability studies.
Responds to chamber alarms during off-hours and weekends (i.e. assigned rotation; coordinates with team members to ensure chamber alarms are acknowledged and resolved)
Ensures that the corresponding internal SOP s, company policies and procedures, and cGMP/HA guidelines are followed in all processes related to the Stability Programs by all involved parties
Ensures communication flow in the Stability Service team and with all individual involved in the stability program process (e.g. planners, etc.)
Annual Stability Report Writing:
Responsible for the compilation and data interpretation of analytical and regulatory data.
Responsible to draw conclusions from real-time data and statistical reports. Use Minitab to evaluate and trend stability data.
Responsible to ensure that established testing control procedures were followed.
Responsible for providing Annual Stability Reports to Drug Regulatory Affairs for timely submission to the FDA
Responsible for providing stability data and reports for product related evaluations, e.g., compliance investigations, divestitures, product transfers, validation, etc.
Responsible for managing data and instructing others in the Annual Stability Report writing function.
Responsible for the Annual Stability Reports record keeping.
Minimum 3 years experience in a regulated pharmaceutical manufacturing and/or or quality control setting.
Experience in the stability field and knowledge of stability regulation and its application to the industry is preferred.
Excellent organizational skills/ability to manage multiple priorities and deliver on agreed to timelines.
Attention to detail/quality of work
Excellent communication and interpersonal skills including use of tact, diplomacy, discretion and judgment.
Flexibility/adaptability to take on additional work assignments in support of departmental objectives
Bachelor s degree or equivalent 4-year university in scientific discipline/natural science required.