What are the responsibilities and job description for the Chemist B position at Aurobindo Pharma USA, Inc.?
Division Overview
Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical prouct development and manufacturing. Aurolife has a 10 year history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has given Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.
Job Overview
Responsible for performing sampling, testing, and analysis of raw materials, in-process materials, finished products, and stability samples in accordance with approved specifications, test methods, and regulatory requirements. Operates and maintains analytical instruments, accurately documents and reviews analytical data, and ensures compliance with cGMP, cGLP, Data Integrity, and safety requirements. Supports laboratory investigations, instrument calibration and maintenance activities, preparation and review of laboratory documents, and contributes to the timely release of materials and products while maintaining the highest standards of quality, accuracy, and regulatory compliance.
Responsibilities
Perform sampling and routine/advanced physical, chemical, and instrumental analyses of raw materials, active pharmaceutical ingredients (APIs), in-process samples, finished products, cleaning validation samples, and stability samples.
Conduct testing using laboratory instruments including HPLC, GC, UV-Visible Spectrophotometer, FTIR, Particle Size Analyzer, Karl Fischer Auto Titrator, Bulk Density Apparatus, and other QC laboratory equipment.
Independently plan daily laboratory activities to ensure timely completion of assigned testing.
Prepare, standardize, and maintain adequate inventories of reagents, volumetric solutions, standards, and laboratory consumables.
Organize and prioritize testing activities to meet established timelines and business requirements.
Independently perform routine testing and support execution of complex analyses under the guidance of senior staff or supervisors.
Ensure timely reporting of analytical results and notification of any atypical findings.
Accurately record raw data, calculations, observations, and test results in controlled laboratory records and electronic systems.
Ensure all documentation complies with Good Documentation Practices (GDP) and ALCOA Data Integrity principles.
Prepare, revise, and review analytical test procedures, standard operating procedures (SOPs), specifications, protocols, reports, and laboratory documentation as assigned.
Perform routine calibration, verification, maintenance, and qualification activities of laboratory instruments and equipment as per approved procedures.
Maintain instrument logbooks and ensure equipment remains in a qualified and compliant state.
Participate in laboratory investigations including OOS, OOT, deviations, atypical results, and laboratory incidents.
Assist in troubleshooting analytical methods, instruments, and test-related issues under supervisory guidance.
Support implementation of corrective and preventive actions (CAPA).
Perform technical review of analytical data, laboratory notebooks, worksheets, chromatograms, calculations, and associated documentation.
Verify compliance with approved methods, specifications, and documentation requirements prior to result reporting.
Qualifications - Skills & Requirements
Min
USD $65,000.00/Yr.
Max
USD $75,000.00/Yr.
Physical Requirements
FIELD - While performing the duties of this job the employee is required to:
Physical Requirements
No Additional Requirements
Blood/Fluid Exposure Risk
Category II: Usual tasks do not involve exposure to blood, body fluid, or tissues but job may require performing unplanned Category I tasks.,
Perform sampling and routine/advanced physical, chemical, and instrumental analyses of raw materials, active pharmaceutical ingredients (APIs), in-process samples, finished products, cleaning validation samples, and stability samples.
Conduct testing using laboratory instruments including HPLC, GC, UV-Visible Spectrophotometer, FTIR, Particle Size Analyzer, Karl Fischer Auto Titrator, Bulk Density Apparatus, and other QC laboratory equipment.
Independently plan daily laboratory activities to ensure timely completion of assigned testing.
Prepare, standardize, and maintain adequate inventories of reagents, volumetric solutions, standards, and laboratory consumables.
Organize and prioritize testing activities to meet established timelines and business requirements.
Independently perform routine testing and support execution of complex analyses under the guidance of senior staff or supervisors.
Ensure timely reporting of analytical results and notification of any atypical findings.
Accurately record raw data, calculations, observations, and test results in controlled laboratory records and electronic systems.
Ensure all documentation complies with Good Documentation Practices (GDP) and ALCOA Data Integrity principles.
Prepare, revise, and review analytical test procedures, standard operating procedures (SOPs), specifications, protocols, reports, and laboratory documentation as assigned.
Perform routine calibration, verification, maintenance, and qualification activities of laboratory instruments and equipment as per approved procedures.
Maintain instrument logbooks and ensure equipment remains in a qualified and compliant state.
Participate in laboratory investigations including OOS, OOT, deviations, atypical results, and laboratory incidents.
Assist in troubleshooting analytical methods, instruments, and test-related issues under supervisory guidance.
Support implementation of corrective and preventive actions (CAPA).
Perform technical review of analytical data, laboratory notebooks, worksheets, chromatograms, calculations, and associated documentation.
Verify compliance with approved methods, specifications, and documentation requirements prior to result reporting.
Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical prouct development and manufacturing. Aurolife has a 10 year history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has given Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.
Job Overview
Responsible for performing sampling, testing, and analysis of raw materials, in-process materials, finished products, and stability samples in accordance with approved specifications, test methods, and regulatory requirements. Operates and maintains analytical instruments, accurately documents and reviews analytical data, and ensures compliance with cGMP, cGLP, Data Integrity, and safety requirements. Supports laboratory investigations, instrument calibration and maintenance activities, preparation and review of laboratory documents, and contributes to the timely release of materials and products while maintaining the highest standards of quality, accuracy, and regulatory compliance.
Responsibilities
Perform sampling and routine/advanced physical, chemical, and instrumental analyses of raw materials, active pharmaceutical ingredients (APIs), in-process samples, finished products, cleaning validation samples, and stability samples.
Conduct testing using laboratory instruments including HPLC, GC, UV-Visible Spectrophotometer, FTIR, Particle Size Analyzer, Karl Fischer Auto Titrator, Bulk Density Apparatus, and other QC laboratory equipment.
Independently plan daily laboratory activities to ensure timely completion of assigned testing.
Prepare, standardize, and maintain adequate inventories of reagents, volumetric solutions, standards, and laboratory consumables.
Organize and prioritize testing activities to meet established timelines and business requirements.
Independently perform routine testing and support execution of complex analyses under the guidance of senior staff or supervisors.
Ensure timely reporting of analytical results and notification of any atypical findings.
Accurately record raw data, calculations, observations, and test results in controlled laboratory records and electronic systems.
Ensure all documentation complies with Good Documentation Practices (GDP) and ALCOA Data Integrity principles.
Prepare, revise, and review analytical test procedures, standard operating procedures (SOPs), specifications, protocols, reports, and laboratory documentation as assigned.
Perform routine calibration, verification, maintenance, and qualification activities of laboratory instruments and equipment as per approved procedures.
Maintain instrument logbooks and ensure equipment remains in a qualified and compliant state.
Participate in laboratory investigations including OOS, OOT, deviations, atypical results, and laboratory incidents.
Assist in troubleshooting analytical methods, instruments, and test-related issues under supervisory guidance.
Support implementation of corrective and preventive actions (CAPA).
Perform technical review of analytical data, laboratory notebooks, worksheets, chromatograms, calculations, and associated documentation.
Verify compliance with approved methods, specifications, and documentation requirements prior to result reporting.
Qualifications - Skills & Requirements
- Minimum 3-5 years experience in pharmaceuticals and must have 2-4 year experience in Analytical testing
- Experience in Generic Pharmaceutical industries would be preferable
- Knowledge in Good Documentation practices. Knowledge in USP/ICH/FDA
- Ability to learn quickly and decision making skills .
- Minimum BS with Scientific field
- BS with Chemistry is one of the subjects would be preferable
- Medical and Rx Benefits choice of four medical plans through Horizon. Rx automatically provided with medical benefits
- Dental Benefits with three dental plan options through CIGNA
- Vision Plan with two plan options through VSP
- Life Insurance, Basic Life and AD&D and Supplemental Life Insurance
- Disability Insurance, Voluntary Short-Term Disability and State Disability
- Long-Term Disability (LTD), State (short term) disability – where applicable
- FSA (Flexible Spending Accounts) – Both Health Care & Dependent Care Available
- HSA (Health Savings Account)
- 401(k) Plan - Through Fidelity / Employer Match / fully vested after 3 years
- Employee Assistance Program (EAP) - 100% Confidential and 100% company paid
- Critical Illness and Accidental Insurance
- Legal and Identity Theft Insurance
- Paid Time Off - Paid vacation, PTO, Holiday
Min
USD $65,000.00/Yr.
Max
USD $75,000.00/Yr.
Physical Requirements
FIELD - While performing the duties of this job the employee is required to:
- Work in a temperature controlled office environment or travel via vehicle or commercial transportation
- While performing the duties of this job, the employee is occasionally required to handle or feel objects, talk, hear, and walk during the course of employment
- Position requires some degree of travel for business purposes
- Employee may use computer, phone, copier and other office equipment in the course of a day
- Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and an ability to adjust focus Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
Physical Requirements
No Additional Requirements
Blood/Fluid Exposure Risk
Category II: Usual tasks do not involve exposure to blood, body fluid, or tissues but job may require performing unplanned Category I tasks.,
- Minimum 3-5 years experience in pharmaceuticals and must have 2-4 year experience in Analytical testing
- Experience in Generic Pharmaceutical industries would be preferable
- Knowledge in Good Documentation practices. Knowledge in USP/ICH/FDA
- Ability to learn quickly and decision making skills .
Perform sampling and routine/advanced physical, chemical, and instrumental analyses of raw materials, active pharmaceutical ingredients (APIs), in-process samples, finished products, cleaning validation samples, and stability samples.
Conduct testing using laboratory instruments including HPLC, GC, UV-Visible Spectrophotometer, FTIR, Particle Size Analyzer, Karl Fischer Auto Titrator, Bulk Density Apparatus, and other QC laboratory equipment.
Independently plan daily laboratory activities to ensure timely completion of assigned testing.
Prepare, standardize, and maintain adequate inventories of reagents, volumetric solutions, standards, and laboratory consumables.
Organize and prioritize testing activities to meet established timelines and business requirements.
Independently perform routine testing and support execution of complex analyses under the guidance of senior staff or supervisors.
Ensure timely reporting of analytical results and notification of any atypical findings.
Accurately record raw data, calculations, observations, and test results in controlled laboratory records and electronic systems.
Ensure all documentation complies with Good Documentation Practices (GDP) and ALCOA Data Integrity principles.
Prepare, revise, and review analytical test procedures, standard operating procedures (SOPs), specifications, protocols, reports, and laboratory documentation as assigned.
Perform routine calibration, verification, maintenance, and qualification activities of laboratory instruments and equipment as per approved procedures.
Maintain instrument logbooks and ensure equipment remains in a qualified and compliant state.
Participate in laboratory investigations including OOS, OOT, deviations, atypical results, and laboratory incidents.
Assist in troubleshooting analytical methods, instruments, and test-related issues under supervisory guidance.
Support implementation of corrective and preventive actions (CAPA).
Perform technical review of analytical data, laboratory notebooks, worksheets, chromatograms, calculations, and associated documentation.
Verify compliance with approved methods, specifications, and documentation requirements prior to result reporting.
Salary : $65,000 - $75,000