STABILITY STUDY DIRECTOR

Applies job skills and company's policies and procedures to complete a variety of tasks. Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required. Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.

Location: Hayward, CA

Industry: Pharmaceutical

Hours: 8 hours/ Day Shift, Monday - Friday

Salary: $55.16/ hourly paid weekly (Benefits Available)

Employment Type: Long Term Contract - Possible hire

Key Accountabilities:

As a Stability Scientist you will assume a Study Director role which will be responsible for managing Stability studies. All work is expected to be carried out in a safe and compliant manner in accordance with local EHS policies, ICH and cGMP guidelines.

Key Duties:

The following are responsible tasks, but not limited to:

Create Stability Study Protocols

Perform Stability Study Setup

Perform Aseptic Sample Aliquoting

Perform Stability Sample Pull

Sample Shipping to External Testing Labs (Other Sites and Third Party Labs)

Scheduling Testing Requirements

Compile Testing Data for Timepoint

Review results for Acceptance and Trending

Create Stability Study Data Tables

Create Interim and Final Reports

Attend Project Team Meeting (IPT)

Provide Guidance to Stability Analysts

Manage Critical Reagents Levels and Availability

Perform Document Revision

Perform Change Control Request

Order Consumables and Testing Materials

Communicate and Work with Internal (Hayward) and External Team (Other Sites and Third Party Labs).

EOE/ADA