Description
International pharmaceutical client is looking for a QA Quality Assurance Investigator. This is a 6 month contract position. $75/hr all inclusive. This an exciting opportunity to gain excellent knowledge working with a large pharmaceutical company in New Brunswick, New Jersey.As the QA Quality Assurance Investigator your responsibilities will include:
Assist with document management and cGMP training, document archiving and organization. Perform internal and external audits of CMOs.
Compile
data and documents required for performing and writing the investigation.
Work with external auditors to collect data packages and provide summaries for supplier approval. Review test records and data for compliance to SOPs and specifications and report abnormalities.
Own and perform deviation, Out-of-Specifications and out-of-trends investigations within certain timelines . Investigate and write investigation reports for nonconformation and OOS test results Gather required data and investigation evidence from various sources (validation & batch documentation, standard operating procedures, testing and manufacturing specifications, testing results, training & calibration records, & site/corporate policies).
Performs root cause analysis, product impact assessment, conduct investigations to assess impact on products and process, recommends product disposition and recommends change controls and CAPA's as needed.
Address root cause, CAPA and final impact assessment and routing in TrackWise.
Work with cross-functional groups to come up with solutions and creatively solve problems.
Requirements:
5-10 years experience working in pharmaceutical Quality Assurance
-BS in Life Science of related fields
-Knowledge of ICH GCP, FDA Code of Federal Regulations and other applicable regulatory authority laws and regulations-Experience in responding to regulatory inspections preferred
-excellent technical writing skills