17 days old

Quality Investigator

Kelly Services
Indianapolis, IN 46202
_Do you have a passion for science ? Would you like to be a part of the mission to provide high quality medicines within the biopharmaceutical industry ?_

Kelly Science and Clinical is partnering with an Indianapolis based bio-pharmaceutical company that specializes in complex injectable formulations, including drug delivery technology and rare disease product for a small population

Quality Investigator

+ Investigator is responsible for providing timely resolution of assigned deviations, ensuring that the investigations are thoroughly investigated to determine root cause, and that robust CAPAs are implemented whenever necessary. The investigator will be assigned specific areas for which they will be responsible for deviation investigation.

+ The investigator will coordinate with the area, technical support, and other personnel to facilitate completion of deviation investigations.

+ The investigator will keep track of deviations for assigned area(s) and help to ensure deviations are evaluated and closed per timing requirements.

**_Major Position Activities & Responsibilities:_**

+ Deviation Investigation:

Process deviations within the quality management system and conduct thorough root cause investigations. This will require interviewing personnel involved and interacting with technical support and other personnel to determine root causes of the deviations and to assess impact. Deviation investigation will also require reviewing instructions, reference material, and documentation to understand the processes being investigated and what went wrong.

+ Deviation Tracking:

Track deviations for area assigned to help ensure on-time completion of each step.

+ Training and Quality of Investigations

Assist manager in developing processes and delivering training to improve the quality of non-conformance documentation and investigations.


+ Tracking and completing deviation investigations for areas assigned and assisting manager in improving the quality of investigations.

**_Background Qualifications:_**

+ Bachelors degree in a science or engineering field

+ Minimum of 5 years of experience required in a pharmaceutical manufacturing site environment

+ Advanced user of Microsoft Office products, including Excel, Word, Access, and PowerPoint

+ Use and system knowledge and experience of Quality Management Systems

+ Ability to interface with personnel from multiple areas to deliver results (e.g., complete deviation investigation)

+ Demonstrated ability to write through, clear, concise, and logically organized technical documents

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (
Posted: 2021-09-06 Expires: 2021-10-07

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Quality Investigator

Kelly Services
Indianapolis, IN 46202

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