Temporary Data Reviewer


Job ID 19-00119

Industry Pharma

Job Type Contract

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 Chemistry 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 Chemistry instrumentation use, accuracy of calculations and conformance to all referenced Chemistry 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. 

ESSENTIAL FUNCTIONS:
Include the following. Other duties may be assigned.
- Responsible for ensuring the integrity of all data and documentation reported from the Chemistry 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 Chemistry data
- Responsible for verifying all laboratory testing was conducted in accordance with SOPs as well as cGMPs
- 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

QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. 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, Chemistry, 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 testing is preferred.

JOB PREREQUISITES:
- Ability to meet attendance standards. All full-time employees are required to work a 40 hour week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines. 
- Must have complete knowledge of pharmaceutical chemistry testing and the ability to clearly interpret department procedures, current Good Manufacturing Practices, United States Pharmacopeia, Code of Federal Regulations (CFR) and other applicable FDA regulations or guidelines.
- Must be detail oriented. 
- Must have a team work attitude.