Job Description
Job DescriptionPOSITION SUMMARY
The Specialist Batch Disposition is responsible for issuing batch records to the production floor, review of
executed 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 industry
related experience in Pharmaceutical and/or Biotechnology.
EXPERIENCE
* 2+ Years of Pharmaceutical and/or Biotechnology Industry Quality Assurance Experience, ideally all clinical
phases through commercial drug product. Regulated STEM industry preferred