Batch Disposition Specialist

POSITION SUMMARYThe Specialist Batch Disposition is responsible for issuing batch records to the production floor, review ofexecuted batch records and product release.ESSENTIAL FUNCTIONS

• Review batch records, protocols, and reports for accuracy, completeness and to identify any potential issues.
• Perform product release activities using SAP.
• Prepare/issue production records and associated batch documentation.
• Create/revise/maintain COA/COC templates for all products.
• Prepare department-specific metrics for management review.
• Perform data entry activities for department databases and/or logbooks.
• Assist in compiling data for annual product review.
• Initiate TrackWise investigations for issues found during batch review.
• Other duties as assigned.

Pay: $28.00 - $30.00/hr

POSITION QUALIFICATIONS

• Strong computer skills highly preferred (i.e., Adobe Acrobat, MS Word, Excel, Access, etc.)
• Must be able to work weekends on occasion.
• Accuracy

• Ability to perform work accurately and thoroughly.

• Time Management

• Ability to utilize the available time to organize and complete work within given deadlines.

• Accountability

• Ability to accept responsibility and account for his/her actions.

• Detail Oriented

• Ability to pay attention to the minute details of a project or task.

• Persistence

• Ability to complete tasks or continue in a course of action despite opposition or discouragement.

• Must be able to move about the facility.
• Must be able to remain sedentary for periods of time.
• Required to wear personal protective equipment.EDUCATION
• Bachelor"s degree from an accredited college or university or field experience. In lieu of degree 3 years industryrelated experience in Pharmaceutical and/or Biotechnology.EXPERIENCE
• 2+ Years of Pharmaceutical and/or Biotechnology Industry Quality Assurance Experience, ideally all clinicalphases through commercial drug product. Regulated STEM industry preferred