Pharmaceutical Document Reviewer for Quality Control Department, Cranbury, NJ 08520
• Perform review of day-to-day analytical testing data and related quality documents.
• 90% 100% of work will be executing analytical data and/or documents.
• 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 activities based on the situation.
• Originate reports in written or oral form so that new ideas or approaches are brought to the attention of appropriate personnel. Demonstrate critical thinking skills and creativity when solving problems.
1. Compilation and trending of Analytical data.
2. Review and preparation of SOPs, STPs, GTPs and Protocols.
3. Participate periodically with internal audits compliance to cGLP and cGMP in Analytical Lab.
4. Review/ approval of sample login in LIMS and data migration.
• Review of day-to-day Analytical data generated in the Laboratory. Maintains and update essential Laboratory documents as per current regulatory guidelines. Review and Compilation of Analytical Data required for Regulatory filings.
• Serve as department representative and/or technical lead at meetings. May lead and coordinate day-to-day activities of chemists. Participate in discussions and meetings for the purpose of exchanging ideas in relevant areas of interest.
• Day shift (business hours 8:30am-5pm), $25-$28 per hour, Contract to Perm job QUALIFICATIONS
Experience in Generic Pharmaceutical, solid dosage industry is preferable
Knowledge of Good Documentation practices. Knowledge in USP/ICH/FDA
LIMS experience a plus
Minimum BS with Scientific field, BS with Chemistry preferred
Minimum 3-5 years’ experience in pharmaceutical analytical lab
1-2 years’ experience in reviewing QC data.
[ Link removed ] - Click here to apply to QC Pharmaceutical Document Reviewer
Ajulia Executive Search is a search firm specializing in Manufacturing, Finance, IT, Legal and Pharmaceutical positions. This is a confidential search for one of our preferred clients. It is a contract to hire position that includes competitive compensation and full comprehensive benefit package.
Laboratory Information Management Systems
Product Quality Assurance