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15 days old

Operations QC Specialist

Kelly Services
Lansdale, PA 19446
Job Title: Operations QC Specialist


Length of Contract/Assignment/Project Open Ended


Location: West Point, PA.


Description:


The Operations Quality Control Specialist will be responsible for supporting the West Point Clinical Supply Operations (CSO) areas with a focus in Quality Management. Adherence to regulatory, global and site policies and procedures governing operations activities is critical. This position will be the key liaison between CSO and Quality.


Responsibilities:


+ Interface with Quality department in managing NOEs/CAPAs/Change Controls

+ Author NOEs/CAPAs/Change Controls including conducting investigations

+ Author and/or update SOPs

+ Deliver training where applicable

+ Develop and report on Key Quality metrics

+ Conduct routine Quality meetings within the CSO department

+ Understand and apply regulatory/ compliance requirements relative to the role

+ Participate in process improvement or learning events

+ Interact with employees within own department as well as frequent interaction with employees from other groups/departments, i.e. Quality


Qualifications:


Education Requirements:


+ Bachelors Degree or 3-5 years experience in operations


Required:


+ Extensive cGMP and GDP Quality experience in the pharmaceutical industry

+ Strong written and verbal communication skills

+ Microsoft Office experience

+ Solid ability to maintain accurate records

+ Demonstrate competency and in-depth knowledge of all processes, methods and procedures related to supply chain

+ Experience working in specific phases of the clinical trial process

+ Therapeutic experience

+ Experience with working with specific Software, Clinical Trial Management Systems or Databases.

+ Experience working with or writing any specific documents.


Preferred:


+ Ability to quickly learn new systems

+ Knowledge of CFR regulation

+ SAP Experience


Pay Rate $36.00 max


Benefits Offered? Yes


**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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-09-10 Expires: 2021-10-14

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Operations QC Specialist

Kelly Services
Lansdale, PA 19446

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