22 days old

QA Lab Specialist- Summit NJ

Kelly Services
Summit, NJ 07901
**CAPA/ QA Lab Specialist- Summit, New Jersey 07901**

Requirement: CELGJP00009533

**Purpose and Scope of Position:**

Responsible for authoring high-quality documentation in support of GMP manufacturing. This includes but is not limited to deviation investigations, CAPA s, SOP s and Work Practices (Equipment, personnel, manufacturing and batch records).

R **equired Competencies: Knowledge, Skills, and Abilities:**

Bachelor s Degree required, preferable in Science

At least 5-8 years of relevant work experience, preferable in a GMP regulated environment

Must have experience in 'written' deviations, not just 'reviewing' deviations


Direct experience with writing deviations/investigation

GMP (and preferred QA experience)

Must be able to work independently and as a team

**Additional requirements:**

+ Proven working experience in writing GMP documents

+ Performs and documents in writing investigation of manufacturing deviations and events utilizing root cause analysis techniques.

+ Experience in deviations/investigations and determining root cause

+ Problem solving

+ Writes, reviews, and maintains department standard operating procedures

+ Ability to deliver high quality documentation paying attention to detail under accelerated timelines.

+ Ability to quickly grasp complex technical concepts and make them easily understandable in text and pictures

+ Ability to work in a highly regulated environment, following Good Documentation Practice

+ Advanced ability to work in a collaborative team environment and train others

+ Ability to adapt to changing priorities and manage multiple assignments while meeting timelines. Ability to set priorities

**Why Kelly** **** **?**

Kelly Science 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. 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. at
Posted: 2020-06-15 Expires: 2020-07-16

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QA Lab Specialist- Summit NJ

Kelly Services
Summit, NJ 07901

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