Quality Assurance Batch Record

Job Description

Job Description

Title: Batch Disposition Specialist

Location: Whippany, NJ 07981

Duration: 6 Months

Shift: 8 AM to 5 PM

POSITION 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.

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.

We believe in service that helps you solve a problem, move forward with a project, manage a difficult situation, or simply check something off your list.

Company Description

We believe in service that helps you solve a problem, move forward with a project, manage a difficult situation, or simply check something off your list.