Quality Systems Specialist II

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 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 a Quality Systems Specialist II to join our Quality Team…

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

JOB SUMMARY

The Quality Systems Specialist II is an essential part of the Quality Assurance team and will be

responsible for ensuring that the site Quality Systems (CAPA, Non-Conformance, Trending, Change

Management, Complaints) are being followed and are up to current industry standards.

In addition, the

Quality Systems Specialist II is expected to ensure execution of policies and practices for compliance with

DEA Controlled Substance regulations, requirements, and expectations.

RESPONSIBILITIES AND LEARNING OPPORTUNITIES


* Ensures Quality Systems (CAPA, Non-Conformance, Trending, Data Integrity, Customer Complaints, Change Control, etc.) compliance and drives improvements.


* Provide guidance and ensure corrective and preventive actions are adequately and timely implemented and monitor their closure and effectiveness.


* Utilize EDMS/EQMS for processing complaints, reviewing and revising documents, managing training configurations and user groups


* Create Annual Product Reviews for management decision making.


* Investigate Customer Complaints through follow-up and resolution.


* Interact with Customer’s Quality associates to fulfill client needs.


* Participate in Customer/Regulatory audits.


* Audits quality systems and manufacturing practices and ensures that products are produced to specification and that all documentation requirements are consistently adhered to meet safety, quality, and regulatory requirements.


* Proactive in continuous improvement of quality systems and procedures including writing and revising SOPs.


* Conducts investigations to determine root cause and recommends and implements corrective, preventative.


* Collaborate with all departments within the company as required.


* Ensure facility adherence to cGMP’s and SOP’s.


* Unders...