Quality Lab Associate I

2 weeks ago


Marion, United States Kelly Services Full time

Quality Lab Associate I - EM – Water Sampling/Investigations Protocol Support

Kelly is hiring a Quality Lab Associate I for a premiere client in (North Cove) Marion NC.

Day shift
Pay: $24/hr - $25.70/hr depending on experience
Assignment length: 6 months


Supports the environmental monitoring program by performing testing such as water testing, surface testing, viable air monitoring, and air total particle counts. Responsible for conducting routine risk assessments and HEPA filter inspections in clean rooms.

What you'll be doing


Collect environmental monitoring samples throughout the facility following Standard Operating Procedures on a defined frequency
Collect water samples throughout the facility on a daily/weekly/monthly basis
Process water samples for testing of Microbial Total Count and Coliform
Be able to climb ladders/scaffolding for water sampling purposes
Performs weekly Real Time Risk Assessments (RTRA) to identify potential contamination issues in clean rooms
Reviews Environmental Events/Deviations to ensure documentation and testing is complete prior to submitting for approval
Develops joint relationships with Quality Operations/ Manufacturing/Engineering to initiate corrective actions/work orders when issues are identified on the floor
Leads the investigation of microbial out of limits that occur in operations and is responsible for conducting the investigation, determining root cause, and defining effective corrective and/or preventive actions to prevent recurrence
Partners with Quality, Operations, Engineering, Maintenance, and Supply Chain to ensure appropriate and timely determination of scope, product impact, root cause, and CAPAs
Interacts with all levels of staff and provides timely updates on investigation status
Fosters collaborative relationships focused on high-quality and timely investigations, effective corrective actions and the reduction of out-of-limit generation rate
Closes investigations in a timely manner to meet business and compliance needs
Works with minimal supervision to drive investigations to closure
Manages several investigations at a time
Complete testing within required timeframes
Validation Protocol coordination with the Technical Services and Microbiology Group
Sustain a clean and safe work environment applying 6S principles


What you'll bring


B.S. degree in Microbiology, Biology, or related science
0-2 years of experience; minimum 1 year experience in Pharmaceutical/Medical Device industry preferred
Experience in conducting root cause investigations in the pharmaceutical/medical products industry preferred.
Strong communication and project management skills
Possess knowledge of core manufacturing and support systems
Computer literate/knowledge of Microsoft office applications (Word, Excel)
Must have good interpersonal skills and able to work optimally and efficiently in a team-based environment
Proficient in the aseptic use and handling of media plates and swabs for EM sampling
Must be a dedicated individual who requires minimal direction
Attention to detail and strong organizational skills
Must have a basic understanding of laboratory instrumentation
Good documentation skills and knowledge of GDPs (Good Documentation Practices)
Able to manage multiple tasks/priorities in a timely manner
Knowledge of aseptic technique and microbiological testing according to FDA, cGMP, GLPs and USP testing methodology
Familiarity with LIMS (or equivalent system) and TrackWise
Able to communicate optimally with supervisors and peers
Knowledge of FDA quality system regulations is preferred


Other Duties as Assigned
This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Overtime is worked as required.
The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

#P2
 




As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.Why Kelly® Science & Clinical? Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.






About Kelly Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center.
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