Department: Quality Control
Reporting to: Vice President, QC/QA
Location: San Diego, California
Date: August 29, 2017
Compensation: $40,000.00 – $45,000.00 Annual Salary (DOE)
Key responsibilities may include:
• Conduct routine and cGMP analyses of in-process materials, raw materials, finished product samples, or stability samples.
• Interpret test results, compare them to established specifications and control limits for release.
• Perform visual inspections of raw materials and finished products.
• Complete documentation needed to support testing procedures including data capture forms, equipment logbooks, or inventory forms.
• Calibrate, validate, or maintain laboratory equipment.
• Participate in out-of-specification and failure investigations and recommend corrective actions.
• Supply quality control data necessary for regulatory submissions.
• Investigate or report questionable test results.
• Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines.
• Ensure that lab cleanliness and safety standards are maintained.
• Identify quality problems and recommend solutions.
• Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods.
• Train other analysts to perform laboratory procedures and assays.
• Identify and troubleshoot equipment problems.
• Participate in internal assessments and audits as required.
• Evaluate analytical methods and procedures to determine how they might be improved.
• Write technical reports or documentation such as deviation reports, testing protocols, and trend analyses.
• Review data from contract laboratories to ensure accuracy and regulatory compliance.
• Serve as a technical liaison between quality control and other departments, vendors, or contractors.
• Write or revise standard quality control operating procedures.
• Develop and qualify new testing methods.
• Prepare or review required method transfer documentation including technical transfer protocols or reports.
• Evaluate new technologies and methods to make recommendations regarding their use
To perform these duties, the Quality Control Chemist must possess the knowledge of and training on various testing methodologies. In addition, the Quality Control Chemist must be proficient in operating analytical instruments and their related data acquisition and processing systems and methodologies, including HPCL, LC/MS/MS, UV/Vis Spectrophotometer, Viscometer, Dissolution Apparatus, Karl Fisher Apparatus, pH Meter, analytical balances, etc.
A qualified candidate for the position must have at a minimum, a Bachelor’s degree in Chemistry or related field, with training on instrumental methodologies during studies.
Develop, transfer, and implement analytical methods and methods validation for clinical trial materials and pharmaceutical commercial products by HPLC, LC/MS/MS, and other advanced equipment.
Conduct drug substances tests and in-process assays to support new product manufacturing by using a wide variety of instrumentation technology.
Writing method validation protocols, stability study protocols, technical reports and new SOPs.
Carry out pharmaceutical product stability programs; characterization of drug substance; maintaining laboratory under cGMP requirement.
Performance data process and documentation of various types of testing results of samples received in Quality Control Lab by following the appropriate SOPs and cGMP compliance.
Knowledge of or experience in:
c-GMP environment, GLP environment , total organic carbon analyzer, environmental monitoring, cleaning verification, alkaloid drugs, LC-MS, UV-VIS, FT-IR, pH meter, titration, TLC, osmolality, particle size , tablet hardness, moisture content, HPLC Fluorescence detector/RID /UV detector (including trouble shooting), Method Development, Title 21 CFR Part 11, FDA guidelines, anti-cancer drug research, writing proposals and reports, dissolution studies, calibration of instruments, analytical test for the raw materials, in-process and final product
• Able to work in the fast pace environment
• Knowledge of pharmaceutical regulatory safety requirement is a plus
• Develop and validate standard operating procedures
• Moreover Aseptic technique, Bio burden, Antimicrobial effectiveness, Specified microorganism and should be familiar with USP 51, 61, and 62, is a plus
• Experience with handling of microorganisms such as bacteria and fungi
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.
If you are interested in being part of the IriSys LLC team, please submit your Cover Letter and CV by completing the following form:
Or you may email your CV and Cover Letter directly to HR@irisys.com
Please put the job reference “QC Chemist”in the subject line of the email.