Analytical Lab Auditor

Are you ready to join a growing, global drug development and manufacturing organization that puts people first?  Come to Adare!  We work closely with our pharmaceutical industry partners during all phases of drug development and commercial manufacturing with a mission of improving the lives of patients and medicines essential to people all over the world.  Each role and every department within Adare offer you a unique, customized experience with a chance to make a real impact, and is critical to our success.  With the help of people like you dedicated to our mission, Adare is transforming lives by transforming drug delivery!

Join our mission at Adare!

What can Adare offer you?


* Medical/dental/vision/life – low employee premiums


* 401k with a highly competitive match


* Generous PTO, including floating holidays


* Career growth and internal opportunities


* Tuition reimbursement


* Relocation assistance


* Performance-based bonus


* Employee Recognition Programs

 

We are seeking to hire an Analytical Lab Auditor to join our Quality team…

If any of the below describes you, we would love to meet you! 

JOB SUMMARY

The Analytical Lab Auditor is responsible for ensuring analytical compliance to GMPs by auditing laboratory documentation regarding physical and chemical testing for raw materials, intermediates and finished products for commercial release and stability testing.  They perform more complex method changes and be the owner for certain project related functions.

This position reports to the Manager, Analytical Compliance and works closely with all sub-departments of Analytical Sciences.

RESPONSIBILITIES AND LEARNING OPPORTUNITIES


* Be able to perform responsibilities of the Analytical Compliance Auditor I position.


* Audit analytical laboratory data for correctness, completeness, and compliance with cGMPs and the company’s internal quality standards.


* Follow-up with laboratory staff to facilitate any corrections to data as required.


* As part of the stability program, audit laboratory stability data and coordinate with the Stability Coordinator to manage the stability testing schedule.


* Review and recommend changes to methods under review for approval and also process validation protocols and reports.


* Revise analytical documents as required to maintain cGMP compliance (i.e: SOPs, Test Methods/Test Sheets, CoAs) and coordinate approval through the document management system.


* Participate in Regulatory and Customer audits and complete follow-up actions as required.


* Develop and implement Corrective and Preventative Actions (CAPA) steps based on OOS/Deviation/Complaint investigation outcomes.


* Release quality orders in the ERP system in compliance with all approved specifications for raw materials, intermediates, and finished products.


* Compile data and tabulate Product Quality Report (PQR) information for management decision maki...