MICROBIOLOGY DATA & DOCUMENTATION REVIEWER-PHARMA

Location: Edison, NJ
Date Posted: 04-01-2018
The primary responsibility of the data reviewer is to ensure all data and documentation, including source data and summary reports from the laboratory, are of the highest quality, ensuring data accuracy and integrity. The data reviewer reviews all microbiological data (source data and summary reports) for accuracy, conformance to procedures and specifications, and proper documentation in accordance with SOPs and cGMPs. The assigned individual also reviews raw data, for use of appropriate microbiological instrumentation use, accuracy of calculations and conformance to all referenced microbiological procedures and reviews the interpretation of the data for alignment with method validation reports and scientific legitimacy. The data reviewer reviews all electronic data audit trails in detail to ensure data integrity is not compromised in any way and ensures all signatures, electronic or written are intact prior to the release of laboratory data. 
 
ESSENTIAL FUNCTIONS:
Include the following. Other duties may be assigned.• Responsible for ensuring the integrity of all data and documentation reported from the Microbiology Laboratory• Reviews all source data and associated documentation for accuracy and cGMP conformance.• Reviews all source data for conformance to applicable specifications• Facilitates data or documentation corrections with analysts to ensure all records are complete and appropriate references are made.• Ensures investigations are assigned, completed and referenced for data or documentation, as appropriate, prior to release of Microbiological data• Responsible for verifying all laboratory testing was conducted in accordance with SOPs as well as cGMPs and GLPs• Review of laboratory notebooks and other source data (e.g. printouts, logbooks, executed forms, etc.) for completeness, and archival, as appropriate.• Interacts closely with Quality Management and all team members to identify and aid in the implementation of data security, integrity or efficiency improvements• Interacts routinely with departments such as Production, QA, RA, R&D, Validation• Works on multiple projects in a concurrent manner on a routine basis.• Assist in performing Quality Assurance audits on laboratory areas to ensure cGMP compliance• 
 
ADDITIONAL RESPONSIBILITIES:• Demonstrate a consistent high level integrity, professional discipline and dedication to quality compliance and improvement.• Exhibit a high level of technical aptitude and maintain an approachable demeanor to assist team members of varying capabilities and technical comprehension.
 
Qualifications
 
 The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
 
EDUCATION AND EXPERIENCE:
Must have a minimum of a Bachelor's degree (BS) in the Life Sciences (e.g., Biology, Microbiology, Biochemistry, or closely related field) from an accredited four-year college or university with at least three (3) years of experience in an industrial laboratory related to pharmaceutical manufacturing, specializing in sterile dosage forms. Knowledge of pharmaceutical microbiology testing is preferred.
Very competitive salary and benefits!
Great company to work for!
Full relocation package is available!
Don't miss out! Apply now and we'll be in touch immediately with more specific details, salary information and to answer any questions!!

This position does NOT provide sponsorship so please do NOT apply if you require sponsorship.  Thank You

KP Recruiting Group 
"Bringing Talent to the Marketplace"

KP Recruiting Group is a well established and very respected recruiting firm.  We have built a strong reputation as a premier resource for providing highly qualified candidates for our clients.  We are very experienced in many industries and have a wide range of clients.  We will serve as your advocate during your career search!  Let us do the work for you!  There is never a fee for our services!



 
or
this job portal is powered by CATS