Employment Type: Full-time
Job Title: Senior Quality Assurance Specialist
Department: Quality Assurance
Reporting to: Executive Director, Quality Assurance & Regulatory Affairs
Location: San Diego, California
Date: June 21, 2019
IRISYS LLC has an open position for a Senior QA Specialist. Candidate should have working experience in cGMP pharmaceuticals manufacturing compliance. Experience in FDA inspection or Pre-approval inspection is a plus. The responsibilities include but are not limited to:
• All activities related to quality assurance of pharmaceutical raw materials, pharmaceutical product analysis and product stability programs.
• Review and analyze quality control and microbiological data pertaining to high-performance liquid chromatography (HPLC), mass spectrometry, particle size, hardness, titration, thin-layer chromatography (TLC), moisture content, pH, total organic carbon (TOC), FTIR etc. to release pharmaceutical raw materials and final drug products.
• Ensure proper calibration, qualification, and maintenance of laboratory instruments such as HPLC, LCMS, TOC etc.
• Review validation documents and standard operating procedures pertaining to analytical methods, reports and instruments processes.
• Coordinate product stability study, review stability analytical data and generate product stability report.
• Provide quality guidance in evaluating cGMP (current Good Manufacturing Practices) in order to support the timely release of drug products and maintain a state of inspection readiness.
Knowledge of or experience in either:
HPLC, MS, TOC, UV-Visible, FTIR and other spectroscopy techniques, and maintenance, calibration and troubleshooting of these instruments. Experience with analytical method development using HPLC, developing product assays, and good laboratory practices. Capable of writing scientific proposals and technical reports, analyzing scientific data, and stability study summary reports;
Experience with current Good Manufacturing Practices (21 CFR 210/211) and performing line clearances, manufacturing process and/or equipment validation, maintaining a calibration/preventative maintenance database and performing internal audits. Capable of writing/reviewing manufacturing batch records, reviewing deviations and performing Corrective Action/Preventive Action (CAPA) investigations.
A qualified candidate for the position must have at a minimum, a master’s degree in chemistry, Biotechnology, Biochemistry or a related field plus 2 – 4 years of relevant experience with high-performance liquid chromatography (HPLC) and mass spectrometry, or 3 – 5 years relevant experience in a cGMP commercial liquid or solid oral/topical dosage or aseptic filling manufacturing environment.
The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all of the specific requirements of the job. These job duties/responsibilities may change or vary in response to business needs.
To Apply: If you are interested in being part of the IriSys LLC team, please email your CV and Cover Letter directly to HR@irisys.com. Please put the job reference "Senior QA Specialist " in the subject line of the email.
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