Job Description

POSITION SUMMARY:

This position will report to quality management (QA/QC Manager). The QC Data Reviewer will be responsible for review of various data and documentations generated by Quality control department as per cGMP and company procedures. The QC Data Reviewer will meet departmental, company, and Quality goals by accomplishing the following responsibilities:

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

Quality review of QC lab generated data and documentation for accuracy, completeness, and compliance in timely manner. Audit trails review of analytical instrumentation to ensure data integrity. Raw data note book review for documented information such as calculation verification, standard/sample preparation, reagent preparation, instrument calibration, reagent expires, logbook entries, control charts, etc. Facilitates laboratory data or documentation corrections with analysts to ensure accuracy.

Must have a working knowledge of the analytical instrumentations (HPLC, GC, Dissolution, Particle size analyzer, UV-Vis, FTIR, KF, etc.) and able to understand and interpret chromatographic and other analytical data. Assist laboratory to investigate any Out of Specification (OOS) results and deviations. Must be able to perform the trend analysis for the laboratory test results. Create/ update Standard Operating Procedures (SOPs) as required. Provide support to Quality Assurance to perform Internal cGMP Audits. Completes other duties as assigned by Quality (QA/QC) management.

QUALIFICATIONS:

Master’s Degree in science with 3-5 years of professional experience in pharmaceutical industry, or Bachelor’s Degree in science with 5-8 years of professional experience in pharmaceutical industry. Expertise in MS Office applications, in particular MS Word and Excel, is required. Excellent communication skills (verbal and written). Able to work in fast-paced environment and manage multiple and diverse tasks simultaneously. Proven ability to organize and plan work both independently and in conjunction with team members.

Company Description

Premier provider of high quality, affordable generic medicines. Rapidly growing developer and manufacturer of generics founded and based in the United States. Our products appear in various dosage forms across multiple therapeutic areas. We market products to all pharmaceutical channels including local and national retailers, wholesalers, distributors, health systems, and government.