A Quality Control Chemist uses chemistry analysis to test samples of manufacturing or pharmaceutical products, to ensure that products meet quality standards.
Review laboratory notebooks and all analytical data originating from in-house and outside contact testing labs. Review •analytical method validation/protocols, method verification protocols/ reports, draft methods, and other relevant analytical data. Review calibration data of laboratory equipment to ensure compliance with SOPs, CGLP and cGMP. Ensure all lab and manufacturing related documentation is current, accurate and in the manner required. Ensure all activities related to stability testing are complete within the stability timeframe. Prepare and review the stability data, stability summary reports, certificate of analysis and any documentation required for filing of ANDA''s. Review all compendial methods and procedures, as needed. Review laboratory related deviations, OOS, OOT and other investigations. Review and maintain all documentation (equipment qualifications, calibration reports, archived logbooks\ notebooks, GMP documents, etc.). Review all production/analytical equipment qualification (IQ/OQ/PQ) and calibration documents. Review batch evaluation protocols/reports, batch records and other production related documents, as needed. Review manufacturing deviations and investigations. Ensure all activities are documented in a legible manner following established formats and good documentation procedures. Coordinate the review of ANDA projects as per priority. Draft, review and update •SOPs to be compliant with the current regulatory guidance and provide official copies of approved documents to the respective departments, as needed. Review QA systems and identify gaps for remediation. Promote an environment of continuous improvement and enhance efficiency & effectiveness of the data review process Perform other duties as assigned. •.
QUALIFICATIONS
Bachelor's Degree in Chemistry, Pharmaceutical Sciences, Biology or equivalent is required. Master's Degree in any of the above disciplines is preferred 5 years of pharmaceutical industry experience required. Proficiency is writing and reviewing reports, protocols and SOP's, and in filing ANDAs. GLP/cGMP documentation experience is a must. Prior experience reviewing laboratory and manufacturing deviations and investigations. Knowledge of QA systems. Excellent verbal and written communications skills. Strong interpersonal and relationship building skills. Proficient in Microsoft Word, Excel and PowerPoint.
Job Type:
Full-time Pay:
$65,000.00 - $80,000.00 per year
Benefits:
401(k) Dental insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid time off Vision insurance
