Microbiology Data & Documentation Reviewer, 2nd shift


Job ID 18-00074

Industry Pharma

Job Type Permanent

Location Somerset, NJ

Description

SUMMARY:
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 Company 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. The reviewer is responsible for discussing data interpretation and questions with individual analysts and elevate to Management, if necessary, to determine data disposition. The reviewer reports directly to Microbiology Management.
 

ESSENTIAL FUNCTIONS:
- 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
- Assist in the investigation and review of deviation reports and OOS reports to assure complete and compliant source data.
- Assist in training and mentoring junior analysts on the interpretation of data and use of electronic data systems.


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.
- Maintain a professional demeanor and adapt well in high stress demining environments.
- Communicate regularly and effectively with all levels of the organization.



Qualifications

EDUCATION AND EXPERIENCE:
- Must have a minimum of a Bachelor's Degree in the Life Sciences (e.g., Biology, Microbiology, Biochemistry, or closely related field) from an accredited four-year college or university with at least 3 years of experience in an industrial laboratory related to pharmaceutical manufacturing, specializing in sterile dosage forms. 
- Knowledge of pharmaceutical microbiology testing is preferred. 

 

CANDIDATE DETAILS
2+ to 5 years' experience
Seniority Level - Associate
Management Experience Required - No
Minimum Education - Bachelor's Degree
Willingness to Travel - Never