PeopleShare has an opening for a Quality Technician focused on Batch Records with a Pharmaceutical company in Moorestown, NJ. Experience within a GMP environment is highly desirable.
Title: Quality Technician - Batch Records
Location: Moorestown, NJ 08057
Schedule: Monday - Friday, 8:00 AM - 4:30 PM
Duration: 4 month temp to hire
Pay: $22/hr
Summary
This position is responsible for assuring the GMP compliance of the organization for clinical supplies preparation. The primary focus of this position is the approval of batch records prior to execution, the approval of material specifications and packaging samples, the release of printed labels, and the auditing of executed batch records.
Responsibilities
- Maintain work area in accordance with GMPs.
- Approve proposal-related documentation created by Project Managers, including:
- unexecuted batch records
- packaging samples
- material specifications
- label print batch records
- batch record change controls
- other documents, as needed
- Verify client approval of proposal-related documents that have been previously reviewed
and approved - Audit and release executed batch records (EBRs).
- Interact with clients to resolve issues with completed batch record documentation.
- Work with packaging and Quality Control (QC) personnel to resolve documentation errors
within batch records. - Provide ongoing guidance to packaging personnel to promote quality of batch record
documentation. - Assure control of documentation.
- May assist in the generation, revision or review of standard operating procedures, data
collection forms and work instructions. - Enter and verify data in the Inventory Control System (ICS).
- Create and revise documents in ZenQMS.
- Participate in client audits as necessary.
Requirements
- Bachelor’s degree or equivalent work experience
- Previous successful packaging experience
- Excellent interpersonal skills
- Excellent communication skills
- Excellent reading and writing skills
- English literacy
- Great attention to detail
- Knowledge of cGMPs
- Excellent mathematical skills
- Excellent time management skills
- Knowledge of Microsoft Office Programs including Word, Outlook, Access and Excel
- Familiarity with the pharmaceutical industry
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