Quality Assurance Specialist II
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Job Location:
Kansas City, KS - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Performing critical work that impacts our industry and our worlds 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 Quality Assurance 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 also include document review audits inspections and consulting on quality and compliance issues.
In this role 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:
- Bachelors 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
(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 YOULL GET
Our benefits include and extend beyond the traditional package. At KCAS Bio you will enjoy company sponsored events like food trucks family days and spirit will grow in your career with KCAS will be able to connect with like-minded employees to further KCAS Bios approach to key areas such as wellness inclusion and community will engage as an owner in our stock ownership program. You will have access to the latest technology. And you will be able to invest in the community with paid time off to volunteer.
Learn more about the Benefits at KCAS Bio
WHO WE ARE
We are a fast-growing contract research organization (CRO) headquartered in Kansas City pioneering the latest drug development in both human and animal health for our expertise is growing and so is our need for great people to work in nimble empowered teams committed to one anothers growth. At KCAS Bio we advance both great science AND great people.
KCAS Bio is proud to be an Equal Opportunity Employer. Among other things we provide equal employment opportunities without regard to race color religion national origin ancestry marital status veteran status age disability pregnancy genetic information sex sexual orientation gender identity or any other legally protected category; we recruit qualified candidates without regard to citizenship status based on internal processes that enable us to hire the right candidates consistent with the appropriate U.S. Immigration framework; and (3) we work with and provide reasonable accommodations to individuals with disabilities and for sincerely held religious beliefs observances and practices. Anyone who needs reasonable accommodation may send an email to emailprotectedor call (for TTY assistance call 711) and ask for Human Resources.
IND123
We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed please contact us.
Required Experience:
IC
Key Skills
- Invoicing
- Information Technology Sales
- IT Support
- Audio Visual
- Database Administration
About Company
As a full-service bioanalytical CRO and biomarker partner, KCAS Bio helps accelerate drug development in the pharma and biopharma industries with large and small molecule bioanalysis.
