Stability Program Lead

Stability Program Lead

Bloomington, IN

Req ID 51424BR

Business Title
Stability Program Lead

Business
Global Quality

Sub-Business
Medical Products Support

Country
US

State/Province
Indiana

Location of Position
Bloomington, IN

Shift_
1st

Job Description
Summary :
The Stability Program Representative - Chemistry maintains and oversees the stability program by reviewing stability project plans and stability documentation. This role works closely with Quality Control (QC) Coordinators and Sample Control Specialists to complete stability program activities. This position reports to a Quality Control Chemistry Supervisor.
Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned) :
• Point of contact for stability program for all external and internal project related questions
• Represents QC and the stability program on internal project teams and during on-site visits with clients
• Provides customer service (testing updates, issue resolution, data inquiries, stability program outlines, etc.) to external and internal customers
• Communicates updates / key information to QC management, including new Project/product Information
• Creates and reviews documentation (Stability Project Plans, standard operating procedures (SOPs), Quality Control Master Documents (QCMDs), protocols, regulatory submissions, client SOPs)
• Participates and leads in process improvements activities
• Writes Level 1 and Level 2 Exception Reports and Master Change Control documents

Job Requirements
Job Requirements (Education, Experience and Qualifications ):
• Bachelors degree in a physical science related field required
• Minimum 2 years experience in a pharmaceutical laboratory environment
• Prefer extensive knowledge of QC functions, as well as general knowledge of key departments such as Program Management, Quality Assurance, and Regulatory
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)
Physical / Safety Requirements:
• Must be able to lift 15 lb.
• Must be able to wear personal protective equipment.
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position may require sitting or standing for long periods of time.
• This position requires handling of laboratory chemicals
• Must be able to qualify for 20/40 corrected vision.

Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.