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24 days old

Quality Assurance Technician - Batch Disposition

Kelly Services
Morrisville, NC 27560
**QA Technical Specialist - Batch Disposition**





Position Summary:



Kelly Services is currently seeking a highly motivated individual to join us as QA Technical Specialist - Batch Disposition for one of our top clients in biotechnology located in the Raleigh-Durham, North Carolina area.





Primary responsibilities will be executed batch record review, right first time metrics, deviation review and approval for appropriate root cause analysis and capa effectiveness, work cross-functionally and collaboratively supporting batch record and deviation review, support product manager for client / project management.





Essential Functions and Duties:




+ Batch record review, including QA on the floor

+ Deviation review and root cause analysis skills, including CAPA effectiveness

+ SAP for product release

+ Deviation and CAPA trending / metrics

+ Electronic systems - TrackWise, SAP, Master Control, Compliance Wire, Enfor (CMMS)

+ The importance of being able to manage decisions within the SOP, standard practice, and regulatory framework.

+ Being able to communicate cross-functionally in a positive, inclusive and proactive manner

+ Meet quality and compliance expectations for assigned areas on time, right-fire-time, and implement assigned compliance improvements

+ Compliance area SME

+ Keep current with required site training and internal compliance requirements for assigned compliance areas. Set, monitor, and report progress on goals and development activities



The ideal candidate will:




+ Under limited supervision, meet quality and compliance requirements in Multiple Compliance areas.

+ cGMP Capability: Follow SOPs, understand and apply principles of Std Practices behind the SOPs

+ Act as the SME for Specific Internal Compliance function with limited supervision

+ Has problem solving skills to identify and solve problems within the SOP and Std Practice framework. Can lead small QA groups to investigate, recommend improvements to management, and monitor effectiveness of improvements including non-routine issues

+ Can make decisions within the SOP and standard practice framework for compliance areas in which they are an SME and can assist others in cross functional peer conflict resolution

+ Communicates cross functionally with peers and QA management in both oral and written form

+ Communicate cross-functionally and collaboratively to manage comment resolution on batch records and deviations

+ Demonstrates positive inclusive behaviors, consistently promotes positive team attitude, and supports business objectives





Minimum Education Requirements + Years of experience




+ BS/BA with 6+ years experience OR

+ MS/PHD with no additional experience








**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/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2020-08-31 Expires: 2020-10-01

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Quality Assurance Technician - Batch Disposition

Kelly Services
Morrisville, NC 27560

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