Quality Specialist II

Performing critical work that impacts our industry and our world's health while problem solving and innovating in the field - that is what we get to do every day at KCAS Bio.

If that gets you excited too, then maybe working at KCAS Bio is for you.

As a QA Specialist II at KCAS Bio, you will be accountable for driving results in a fast-paced environment by effectively performing activities of some variety and complexity to ensure quality and compliance with applicable regulatory requirements.

This will include document review, audits, inspections, and consulting on quality and compliance issues.
\\n

In the role of QA Specialist II, we will rely on you for the following:


* Performs quality review and approval of documents, data, protocols, and/or reports


* Performs quality audits and/or inspections, preparing and distributing audit reports to study director, principal investigator, and/or management in a timely manner


* Reviews laboratory deviations and investigations


* Communicates with internal clients on open audits, deviations and/or investigations.

o Follows up on outstanding audits, and related deviations and/or investigations


* Maintains accurate quality assurance files, records, and databases, and may generate metrics reports used to perform analysis and trending


* Provides training assistance in routine quality and compliance topics, for Quality Assurance group and/or other inter-company departments


* Assists with development/writing of quality SOPs, documents and/or reports as needed


* Provides consultation on quality and compliance topics in areas of expertise and assists with quality improvement initiatives as needed


* Assists with quality system continuous improvement activities


* May assist with client audits, where needed


* Follows and interprets instructions given; gathers clarification for thorough understanding of assigned tasks, including prioritization of tasks


* Demonstrates behaviors and attitude that is supportive of others in the department, as well as the organization


* Assists with providing solutions for issues


* Demonstrates client-focus by actions and follow through

To qualify specifically for this role, you will have:


* Bachelor's degree is preferred, but not required


* Experience with GLP, GCLP or GCP required


* Minimum 3 years of relevant Quality Assurance experience and/or related industry experience


* Exposure to and basic awareness of laboratory processes

\\n
(Please note this is a representative summary of responsibilities, not a comprehensive or exclusive list of the duties to be performed in any position.

Employees must follow instructions and perform additional duties as requested.)

WHO YOU ARE

You will thrive at KCAS Bio if you enjoy a relational environment, are purpose- and values-driven, embrace constant development and supportive leadership, and enjoy being part of innovative work.

WHAT YOU'LL GET

Our ben...