Reviewer, QC


Job ID 18-00055

Industry Pharma

Job Type Permanent

Location Lawrenceville, NJ

Description

JOB SUMMARY
Reviewer will perform primarily review of the day-to-day analytical testing data and related quality documents. The Reviewer may execute 90% - 100% of their work at the analytical data and/or documents.
1. Review of day-to-day Analytical data generated in the Laboratory. Maintains and up dates essential Laboratory documents as per current regulatory guidelines. Review and Compilation of Analytical Data required for Regulatory filings.
2. Serves as department representative and/or technical lead at meetings. May lead and coordinate day-to-day activities of other chemists. Communicates with other departments and sections. Participates in discussions and meetings for the purpose of exchanging ideas in relevant areas of interest.
3. Accountable for ensuring that the analytical measurements are accurate and that methods are in compliance with USFDA, and/or other applicable regulatory guidelines, cGMP and corporate requirements. Expected to plan, organize and schedule the activities based on the situation.
4. Demonstrates critical thinking skills and creativity when solving problems. Originates reports in written or oral form so that new ideas or approaches are brought to the attention of appropriate personnel.
REPORTING RELATIONSHIPS
None
Standard Office Hours: 8.30 AM TO 5.00 PM
DUTIES & ESSENTIAL JOB FUNCTIONS PERCENT OF TIME
90% Daily Review of day-to-day analytical data generated in the
10% Daily Prepare, and Review of QC related documents
OTHER FUNCTIONS AND RESPONSIBILITIES
Perform other related duties as required and/or assigned.

 



Qualifications

QUALIFICATIONS REQUIRED
Minimum BS with Scientific field
BS with Chemistry is one of the subjects would be preferable
Minimum 2-3 years experience in pharmaceuticals & 1-2 experience in reviewing QC data.
Experience in Generic Pharmaceutical industries would be preferable
Knowledge in Good Documentation practices. Knowledge in USP/ICH/FDA
Ability to learn quickly and decision making skills