Job Description Major Areas of Responsibility The primary responsibility of the data reviewer is to ensure the integrity of the data generated in the Quality control department related to testing Review of all the testing performed by Quality control chemists and associated documentation for accuracy and cGMP compliance. Audits system audit trails in the empower software, UV software and IR software Assist in review of Laboratory investigations, deviation reports and reports to assure complete compliant data. Assist in training and mentoring a variety of personnel, laboratory documentation, GLP and electronic software related to Quality control instruments. Working on review of multiple projects in a concurrent manner on a routine basis. Interact with Quality assurance on routine basis on the data submitted and corrections if any. Reviewer is responsible to discuss the questions or potential discrepancies in laboratory documentation and audit trails with the supervisors. Elevate and investigate if necessary to determine the impact on the data or data system. Reviewer is responsible for review of laboratory instrument calibration status, log book entries and Column entries etc on routine basis. Review of method validations/verifications/Method transfers protocols, data and reports. Experience in participate in Lab deviations, investigation and Audits if necessary Review of test methods, specifications, protocols and reports. Knowledge and understanding of cGMPs, Good Laboratory Practices and Good Documentation Practices. Demonstrate professionalism to coworkers, customers and an understanding of quality in a regulatory industry Technical expert and experience with the instruments HPLC, GC, AAS, Dissolution, IR, DT, UV etc is must. Must be able to able to work independently, organized, effectively prioritize projects and work in team environment Experience with the control substances testing and handling Proficient with Microsoft word and Excel Experience with laboratory note book documentation is preferred.
Required Knowledge, Skills and Abilities Excellent interpersonal skills and ability to establish and maintain effective working relationships with both internal and external stakeholders Excellent verbal and written communication skills Ability to work with minimal supervision Experience establishing and maintaining relationships with key decision makers Strong analytical skills and ability to understand business and financial implications of contracts
Self-directed Education and Experience Minimum BA or BS required Minimum 3-7 years in analytical development or Quality control of Pharmaceutical Generic Products preferred
Physical Demands This position requires the employee to routinely use a computer and telephone. Ability and willingness to work additional hours as required by business needs
Work Environment General office environment and Lab
Company Description Ingenus Pharmaceuticals, LLC, is a privately-owned U.S. based pharmaceutical company. Our vision is to be recognized as the most innovative, collaborative and responsive company in the generic pharmaceutical industry.
Ingenus believes lower-cost generic medication improves patient access and offsets overall healthcare costs. Since 2010, Ingenus has helped to make a difference by developing, manufacturing and commercializing quality generic medications as cost effective solutions for patients, suppliers and stakeholders all across the healthcare continuum. Associated topics: cytometry, disease, drug discovery, histologist, histology, industrial hygienist, kinesiology, medicine, physiology, vaccine
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.