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1+ months

Good Clinical Practices Auditor

Kelly Services
Spring House, PA 19477
Good Clinical Practices Auditor


Kelly FSP Science and Clinical is currently seeking a Good Clinical Practices Auditor for a long-term engagement with one of our Global Pharmaceutical clients in Spring House, PA. This would ideally be a hybrid role.


This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.


**ESSENTIAL FUNCTIONS:**


Performs all GMP Operations investigations.


Perform various root cause problem solving activities to determine root cause for investigation and to identify effective corrective and preventative action.


Initiate/Execute CAPAs as result of quality investigations.


**EDUCATION and/or EXPERIENCE:**


Bachelors Degree preferably in scientific discipline, with previous writing and/or investigation experience. Strong writing skills required.


Minimum 2 years related experience in a pharmaceutical industry required.


cGMP experience required. Knowledge of 21CFR Parts 210, 211, European Guidance on Advance Therapies preferred.


Familiarity with Cell and Gene therapy modalities preferred.


Experience with Quality document reviews and regulatory inspection processes. Working knowledge of Quality systems (ETS) and Investigation tools.


**LANGUAGE SKILLS:**


Ability to read and interpret SOPs, operating and maintenance instructions and procedure manuals. Ability to speak effectively, present information and respond to questions.


Ability to respond to inquiries or complaints from internal customers, regulatory agencies.


**REASONING ABILITY:**


Ability to interpret and carry out instructions furnished in written, oral, diagram, mathematical or schedule form, particularly Standard Operating Procedures.


Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.).


Ability to define problems, collect data, establish facts and draw valid conclusions.


**COMPUTER ABILITY:**


Previous experience with Microsoft Office tools, including Teams and Outlook. Event Management Systems Trackwise / ETS preferred.


Ability to utilize software to meet business needs. LIMS, SAP, MES experience preferred.


**MATHEMATICAL SKILLS:**


Ability to add, subtract, multiply and divide and convert between standard and metric in all units of measurement, using whole numbers, fractions and decimals. Ability to compute rate, ratio and percent and to draw and/or interpret bar graphs.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**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: 2022-04-08 Expires: 2022-06-09

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Good Clinical Practices Auditor

Kelly Services
Spring House, PA 19477

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