25 days old

Analytical Quality Assurance Associate

Kelly Services
Durham, NC 27722
Kelly Scientific is currently seeking an **Analytical Quality Assurance Associate** for a **DIRECT HIRE** opportunity in Durham, NC.


+ Quality review of QC related data in the form of Certificate of Analyses, text reports, stability trend tables etc.

+ Review and approve cGMP documents such as, protocols, standard operating procedures, analytical test methods, specifications, etc.

+ Quality review of deviations/out of spec investigations and implement/track CAPAs as applicable.

+ Actively participate in continual improvement of operations of the quality system.

+ Ensure that procedures are followed and that are compliant with regulations.

+ Perform audits to ensure regulations and procedures have been followed.

+ Review and approve validation documentation.

+ Review laboratory notebooks for accuracy and correctness.

+ Keep and maintain logbooks.

+ Manage change controls.

+ Maintain and archive cGMP documentation.

+ Write standard operating procedures as needed.

+ Perform line clearances of the manufacturing/ packaging areas and equipment

+ Performing Cleaning Verification/Validation Swabbing of Equipment

+ Capture critical information for Customer Complaint/Deviation investigations/CAPA/Change Controls (when necessary)

+ Review and Approve Preventive Maintenance or Work Orders; (if necessary)

+ Review and approve IQ/OQ/PQ.

+ Collection and inventorying of Retain and/ or Stability Samples

+ Review of equipment, machine, area qualifications

+ Maintaining various logbooks to document the performance or completion of specific functions (ex. Material Receiving Log)

+ Maintaining QA supply inventory


+ Bachelors Degree in Chemistry or related science

+ 3+ years experience performing quality assurance/quality control duties in the Manufacturing or Quality Control area within a pharmaceutical manufacturing environment.

+ Must be a Team player able to effectively communicate with QA Supervisor, QA, Quality Control, Production, and Supply Chain to meet finished product release goals.

+ Be able to work long hours to support production requirements

+ Be available for overtime, including weekends, as needed for production support

+ Possess the ability to analyze information and make consistently good decisions


+ Experience with deviations/incidents and CAPA

+ A familiarity with cGMPS, CFRs, OSHA and FDA regulations

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

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Analytical Quality Assurance Associate

Kelly Services
Durham, NC 27722

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