1+ months

QA Microbiology Speciaist- Edison, NJ

Kelly Services
Edison, NJ 08899
**QA Microbiology Specialist- Edison, NJ 08817-**

**Essential Functions**

+ Authors investigations through root cause analysis, conclusion and CAPA.

+ Communicates and expected timeline and monitors the progress against the timelines for investigational closure.

+ Writes and reviews verification and validation protocols and reports.

+ Adheres to personnel and equipment SOPs and other regulatory requirements.

+ Provides troubleshooting support as needed on tests and equipment.

+ Collaborates the quality of the group.

+ Communicates effectively within the organization and potentially clients.

+ Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

**Education and Experience**

+ Bachelors degree in Chemistry, Microbiology, Biology or related scientific discipline with 5+ years of microbiology or pharmaceutical laboratory experience in a cGMP regulated environment.

+ Previous investigational leadership experience is preferred.

**Functional Competencies**

+ General working knowledge of method development, validation and verification.

+ General working knowledge of FDA, DEA and client inspection audits.

+ Expert knowledge of chemistry and/or microbiology with pharmaceutical emphasis.

+ Expert knowledge of cGMP and Quality Control Systems.

+ General working knowledge of corrective and preventative actions.

+ Awareness of laboratory equipment and application USP and EP testing.

+ Superior planning and organizational skills.

+ Strong detail orientation and project management skills.

+ Good protocol and report writing skills.

+ Excellent computer technology skills.

+ Multitasking and shift priorities as necessary.

+ Excellent technical knowledge of USP/EP/FDA requirements.

+ Understanding of pharmaceutical drug product and substance testing, environmental monitoring methods, and quality principles as applied to a cGMP environment.

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

With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.

**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: 2019-09-18 Expires: 2019-11-18

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QA Microbiology Speciaist- Edison, NJ

Kelly Services
Edison, NJ 08899

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