Sr. Stability Program Specialist

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Position Title: Sr. Stability Program Specialist

Location: Assembly Drive, Rockford, IL

Shift:  1st Shift

Summary of Objective:

The Stability Program Manager position is an integral member of the Quality Control Laboratory team supporting as the subject matter expert for the Laboratory stability chambers and maintain management of the PCI Stability Program which includes managing ICH Stability studies under cGMP conditions. The includes preparing samples, timely launch of stability studies, maintain pull dates and testing, reconciliation and removal of samples from the chambers, management of the stability schedule, logging stability samples into LIMS, and setting up new product/test specifications when it is required. The Laboratory Specialist will also ensure on-time completion and scheduling of all chamber preventative maintenance and calibration activities. Upon completion of each stability study in the program, the Stability Program Manager shall clear the chambers of associated product, contact the Client for disposal requirements and manage the entire Laboratory pharmaceutical product/hazardous waste program. In addition, this position is responsible for managing contract laboratories including sample shipping, analytical testing, invoicing, and results distribution to the appropriate Laboratory Department. This position also serves as one of the Laboratory Safety Officers for the site.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• Receipt and logging of samples into LIMS including setting up new product/test and specifications

• Works in an efficient manner to a high level of accuracy with minimal personal error

• Generation and documentation of raw data in accordance with cGMP and ALCOA principles

• Knowledge of ICH Stability Guidelines

• Training of analysts in stability program management in the absence of the Stability Program Manager

• On time completion of assigned training in ComplianceWire

• Participate in internal Health and Safety audits including developing actions and follow up

• Participates in internal, customer and regulatory audits

• Retains laboratory raw data/products upon completion of testing and retaining of raw data upon issuance of analytical report/CoA

• Maintains a high level of safety and highlights any potential unsafe act immediately to all and works with relevant personnel to prevent further occurrence

• Ensure that all waste materials/solvents are disposed of in a safe and timely manner.

• Leads/participates in implementation and execution of continuous improvement activities

• Play a role in creating and maintaining an atmosphere of teamwork throughout the laboratory

• Efficient organization skills, including the ability to manage multiple processes and priorities effectively

• Excellent communication skills (written and oral), including the ability to navigate potentially challenging situations

• Ability to quickly assess assigned task requirements, identify potential challenges, and communicate effectively across Laboratory Departments in order to successfully execute the task assigned

• Ability to work independently and within team

• Strong computer skills (Microsoft Excel, Powerpoint, Word,  and LIMS)

• This position may require extra hours and/or weekend work.

• This position will require the individual to be on an on-call rotation schedule for off shifts, weekends and holidays in case of emergencies in the stability chambers

• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.

• Performs other duties as assigned by Manager/Supervisor.

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