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Documentation Reviewer II

Kelly Services


Location:
Greenville, NC
Date:
04/25/2018
2018-04-252018-05-24
Job Code:
US45ANCG_24631394
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Job Details

Job Title Documentation Reviewer II

Jobid US45ANCG_24631394

Location: Greenville, NC, 27835, USA

Description **Job Description**

Kelly Services has a temporary position to work as a document reviewer in Greenville, NC

Documentation Reviewer II Department: Pharmaceutical Development Services (PDS) - Analytical Development (AD)

Maintaining an understanding of analytical development for pharmaceutical products and updated knowledge of regulations.

Example of Job Challenges:

Maintaining coherent, complete and accurate documentation according to Good Manufacturing Practices and the company-s Standard Operating Procedures (SOPs).

Authority Levels:

Job tasks are clearly defined but timing or priority decisions must be made sometimes where competing demands must be balanced.

SPECIFIC DUTIES: (with % of time for each task totally 100%)

Review independently all regular technical documents (e.g., batch testing, stability testing and method validation) and associated raw data generated in the PDS - AD with high quality and deliver within agreed schedule. (52.5%)

Ensure the test methods, protocols and SOPs have been followed by the chemists. (15%)

Verify the integrity and traceability of all data generated and reported. (15%)

Follow up with chemists to ensure that all necessary corrections are corrected in accordance with Good Manufacturing Practices standards. (8%)

May be required to travel to different sites depending on business needs (2.5%)

Notify department supervisor/manager regarding omissions, incomplete testing results or other irregularities. (2%)

Other duties as required. (5%)

**Requirements**

Demonstrated computer proficiency with Microsoft Office programs.

Ability to meet deadlines and prioritize

Srong attention to detail.

Proficiency with the English language.

Excellent written and oral communication skills

Demonstrated commitment to our fundamental principles of Integrity, Respect & Excellence

Ability to work both in a team environment as well as independently as required.

Good interpersonal skills.

WORKING CONDITIONS:

Physical Effort: There is little physical effort and fatigue. Walks, stands, and lifts small objects and tools.

Physical Environment: Located in a comfortable indoor area. Any unpleasant conditions would be infrequent and of short duration.

Sensory Attention: Intermittent need to distinguish among or interpret a variety of sensory inputs that occasionally may not be straightforward.

Mental Stress: There is moderate pressure from deadlines or other productivity standard

Bachelor of Science (B.Sc.) or Masters of Science (M.Sc.) in chemistry or related science.

At least 2 years pharmaceutical industry experience in an analytical development functions.

Basic understanding of common analytical technologies e.g. High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultraviolet (UV) spectroscopy, titration

Good understanding of Good Manufacturing Practices, International Conference on Harmonization (ICH) and United States Food & Drug Administration (FDA)

**Highlights**

Apply today for immediate consideration

Call us to our branch - 252-2146411 and ask for Leighann Maldonado

**Why Kelly** **®** **?**

At KellyServices ® , we work with the best. Our clients include 95 of the Fortune100 ™ companies, and more than 70,000 hiring managers rely on Kelly annually to accessthe best talent to drive their business forward. If you only make one career connection today, connectwith Kelly.

**AboutKelly Services** **®**


As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 peoplearound the world and have a role in connecting thousands more with work through our global network oftalent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.



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