Piramal Pharma Solutions
Senior Quality Control Analyst
Piramal Pharma Solutions, Sellersville, Pennsylvania, United States
Overview
PPL Healthcare LLC d/b/a Piramal Pharma Solutions seeks a Senior Quality Control Analyst for its Sellersville, PA location. Duties: Perform physical testing and chemical analysis of raw materials, finished products, stability, and special samples. Prepare samples by properly collecting, handling, and storing samples to prevent contamination or degradation. Prepare samples according to established SOPs. Perform Assay, impurity, content uniformity, blend uniformity, dissolution testing for immediate release and extended-release drug product. Perform chemical tests to confirm composition of chemical compounds. Employ various techniques including high-performance liquid chromatography (HPLC) and gas chromatography (GC) for chemical analyses and dissolution analyses using auto sampler. Conduct data auditing for lot disposition by analyzing test results using statistical methods to determine compliance with established specifications. Assess data to confirm product specifications are met. Maintain proper laboratory methods and procedures by ensuring current Good Manufacturing Practices (cGMP), company SOPs, and USP methods for all testing. Submit all raw data and results into the Laboratory Information Management System (LIMS) by capturing and recording all relevant data and results directly into the LIMS system during the testing process. Responsible for Reagents Preparation by formulating reagents for chemical analysis to ensure accurate and reliable results in laboratory testing.
Responsibilities
Perform physical testing and chemical analysis of raw materials, finished products, stability, and special samples.
Prepare samples by properly collecting, handling, and storing samples to prevent contamination or degradation; prepare samples according to established SOPs.
Perform assay, impurity, content uniformity, blend uniformity, and dissolution testing for immediate release and extended-release drug products.
Perform chemical tests to confirm composition of chemical compounds.
Use techniques including high-performance liquid chromatography (HPLC) and gas chromatography (GC) for chemical analyses and dissolution analyses using an auto sampler.
Conduct data auditing for lot disposition by analyzing test results using statistical methods to determine compliance with established specifications; assess data to confirm product specifications are met.
Maintain proper laboratory methods and procedures by ensuring current Good Manufacturing Practices (cGMP), company SOPs, and USP methods for all testing.
Submit all raw data and results into the Laboratory Information Management System (LIMS) by capturing and recording relevant data during testing.
Prepare reagents for chemical analysis to ensure accurate and reliable results in laboratory testing.
Qualifications
Bachelor's degree in Pharmacy, Chemistry, or related field plus four (4) years of experience as a quality control analyst or closely related occupation in a pharmaceutical or bioanalytical research setting.
Experience must include:
Review of method validation raw data and study raw data for accuracy pursuant to Methods, Protocols and SOPs.
Preparing samples for chemical analysis using chromatographic technique or spectroscopy.
Designing, evaluating and monitoring stability programs for drug products.
Performing chemical analysis of raw materials, in-process and finished pharmaceutical products.
Performing pharmaceutical laboratory quality control/development activities.
How to apply Qualified applicants must send resumes to apply.slv@piramal.com ref: SQCA/SK. Direct applicants only.
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Responsibilities
Perform physical testing and chemical analysis of raw materials, finished products, stability, and special samples.
Prepare samples by properly collecting, handling, and storing samples to prevent contamination or degradation; prepare samples according to established SOPs.
Perform assay, impurity, content uniformity, blend uniformity, and dissolution testing for immediate release and extended-release drug products.
Perform chemical tests to confirm composition of chemical compounds.
Use techniques including high-performance liquid chromatography (HPLC) and gas chromatography (GC) for chemical analyses and dissolution analyses using an auto sampler.
Conduct data auditing for lot disposition by analyzing test results using statistical methods to determine compliance with established specifications; assess data to confirm product specifications are met.
Maintain proper laboratory methods and procedures by ensuring current Good Manufacturing Practices (cGMP), company SOPs, and USP methods for all testing.
Submit all raw data and results into the Laboratory Information Management System (LIMS) by capturing and recording relevant data during testing.
Prepare reagents for chemical analysis to ensure accurate and reliable results in laboratory testing.
Qualifications
Bachelor's degree in Pharmacy, Chemistry, or related field plus four (4) years of experience as a quality control analyst or closely related occupation in a pharmaceutical or bioanalytical research setting.
Experience must include:
Review of method validation raw data and study raw data for accuracy pursuant to Methods, Protocols and SOPs.
Preparing samples for chemical analysis using chromatographic technique or spectroscopy.
Designing, evaluating and monitoring stability programs for drug products.
Performing chemical analysis of raw materials, in-process and finished pharmaceutical products.
Performing pharmaceutical laboratory quality control/development activities.
How to apply Qualified applicants must send resumes to apply.slv@piramal.com ref: SQCA/SK. Direct applicants only.
#J-18808-Ljbffr