What are the responsibilities and job description for the Chemist B position at Aurobindo Pharma USA, Inc.?
Division Overview
Aurolife Pharma 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 Pharma 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 Pharma a jump start in building a solid pharmaceutical portfolio. The Aurolife family consists of an experienced management team with expertise in Manufacturing, R&D, Quality Assurance, Quality Control and Regulatory Affairs. In addition to several formulations in our product portfolio, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make a healthier world.
Job Overview
To perform assigned testing of topical, transdermal and Inhalation products in various stages of manufacturing using wet chemistry, physical and instrumental techniques. The chemist may execute 90% - 100% of their work at the bench.
Responsibilities
QC Chemist B will perform a variety of QC testing to assess the strength, identity and purity of test samples and/or materials. Will work as a member of team to effectively plan and QC analytical testing using established (official and/or in-house) test procedures. The QC Chemist B may execute 90% - 100% of their work at the bench level. Perform assigned sampling, physical, chemical tests and assay on raw materials, active pharmaceutical ingredients, in-process, finished and stability products, using various wet chemicals, physical and instrumental techniques (HPLC, GC, UV-Vis, IR, Particle Size Analyzer, NGI cascade impactor, KF Auto titrator, Bulk Density, and other routine QC instruments) as per as per USP monograph / In-house / any other Compendial monographs. Work with supervisor to plan and make adequate inventory of test reagents and solutions to perform work, assure supplies are ordered as needed to perform assigned work. Work with supervisor to plan and execute testing to meet established time lines. Perform complicated testing with supervisory direction. Record data and results as specified in documentation procedures. Document work clearly and perform tests accurately. Prepare and/or Review Test Procedures, SOPs, and Protocols as assigned. Perform maintenance and calibrations of laboratory instruments/equipment with supervisory direction/training as needed. Perform troubleshooting and investigations under the direction of a supervisor. Comply with all regulatory/in-house requirements (may include but not limited to safety, house keeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity. Review of Analytical documents as required
Qualifications - Skills & Requirements
BS or MS in Chemistry, Pharmaceutical Sciences, or related field is preferable Minimum 5-10 years of experience in pharmaceuticals and must have 5 years of experience in Analytical testing 5 years QC experience in Generic Pharmaceutical industries would be preferable Experience in a cGMP environment is required Experience with dermatological, transdermal, and/or inhaled dosage forms is preferable Knowledge and use of Good Documentation practices Knowledge of USP/ICH/FDA guidelines Ability to learn quickly and having decision making skills
Education & Experience
BS or MS in Chemistry, Pharmaceutical Sciences, or related field is preferable
Physical Requirements
LAB TECHNICIANS - Must be able to bend at the waist and knees as well as twist at the trunk.
Sitting 1-4 Hours Blood/Fluid Exposure Risk Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.
We Are An Equal Opportunity Employer
Aurobindo Pharma USA, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training., BS or MS in Chemistry, Pharmaceutical Sciences, or related field is preferable Minimum 5-10 years of experience in pharmaceuticals and must have 5 years of experience in Analytical testing 5 years QC experience in Generic Pharmaceutical industries would be preferable Experience in a cGMP environment is required Experience with dermatological, transdermal, and/or inhaled dosage forms is preferable Knowledge and use of Good Documentation practices Knowledge of USP/ICH/FDA guidelines Ability to learn quickly and having decision making skills, QC Chemist B will perform a variety of QC testing to assess the strength, identity and purity of test samples and/or materials. Will work as a member of team to effectively plan and QC analytical testing using established (official and/or in-house) test procedures. The QC Chemist B may execute 90% - 100% of their work at the bench level. Perform assigned sampling, physical, chemical tests and assay on raw materials, active pharmaceutical ingredients, in-process, finished and stability products, using various wet chemicals, physical and instrumental techniques (HPLC, GC, UV-Vis, IR, Particle Size Analyzer, NGI cascade impactor, KF Auto titrator, Bulk Density, and other routine QC instruments) as per as per USP monograph / In-house / any other Compendial monographs. Work with supervisor to plan and make adequate inventory of test reagents and solutions to perform work, assure supplies are ordered as needed to perform assigned work. Work with supervisor to plan and execute testing to meet established time lines. Perform complicated testing with supervisory direction. Record data and results as specified in documentation procedures. Document work clearly and perform tests accurately. Prepare and/or Review Test Procedures, SOPs, and Protocols as assigned. Perform maintenance and calibrations of laboratory instruments/equipment with supervisory direction/training as needed. Perform troubleshooting and investigations under the direction of a supervisor. Comply with all regulatory/in-house requirements (may include but not limited to safety, house keeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity. Review of Analytical documents as required
Aurolife Pharma 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 Pharma 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 Pharma a jump start in building a solid pharmaceutical portfolio. The Aurolife family consists of an experienced management team with expertise in Manufacturing, R&D, Quality Assurance, Quality Control and Regulatory Affairs. In addition to several formulations in our product portfolio, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make a healthier world.
Job Overview
To perform assigned testing of topical, transdermal and Inhalation products in various stages of manufacturing using wet chemistry, physical and instrumental techniques. The chemist may execute 90% - 100% of their work at the bench.
Responsibilities
QC Chemist B will perform a variety of QC testing to assess the strength, identity and purity of test samples and/or materials. Will work as a member of team to effectively plan and QC analytical testing using established (official and/or in-house) test procedures. The QC Chemist B may execute 90% - 100% of their work at the bench level. Perform assigned sampling, physical, chemical tests and assay on raw materials, active pharmaceutical ingredients, in-process, finished and stability products, using various wet chemicals, physical and instrumental techniques (HPLC, GC, UV-Vis, IR, Particle Size Analyzer, NGI cascade impactor, KF Auto titrator, Bulk Density, and other routine QC instruments) as per as per USP monograph / In-house / any other Compendial monographs. Work with supervisor to plan and make adequate inventory of test reagents and solutions to perform work, assure supplies are ordered as needed to perform assigned work. Work with supervisor to plan and execute testing to meet established time lines. Perform complicated testing with supervisory direction. Record data and results as specified in documentation procedures. Document work clearly and perform tests accurately. Prepare and/or Review Test Procedures, SOPs, and Protocols as assigned. Perform maintenance and calibrations of laboratory instruments/equipment with supervisory direction/training as needed. Perform troubleshooting and investigations under the direction of a supervisor. Comply with all regulatory/in-house requirements (may include but not limited to safety, house keeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity. Review of Analytical documents as required
Qualifications - Skills & Requirements
BS or MS in Chemistry, Pharmaceutical Sciences, or related field is preferable Minimum 5-10 years of experience in pharmaceuticals and must have 5 years of experience in Analytical testing 5 years QC experience in Generic Pharmaceutical industries would be preferable Experience in a cGMP environment is required Experience with dermatological, transdermal, and/or inhaled dosage forms is preferable Knowledge and use of Good Documentation practices Knowledge of USP/ICH/FDA guidelines Ability to learn quickly and having decision making skills
Education & Experience
BS or MS in Chemistry, Pharmaceutical Sciences, or related field is preferable
Physical Requirements
LAB TECHNICIANS - Must be able to bend at the waist and knees as well as twist at the trunk.
- Must practice good personal hygiene
- Must be able to lift up to 25 lbs.
- Must be able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
- Position requires working in the laboratory as well as sitting Additional
Sitting 1-4 Hours Blood/Fluid Exposure Risk Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.
We Are An Equal Opportunity Employer
Aurobindo Pharma USA, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training., BS or MS in Chemistry, Pharmaceutical Sciences, or related field is preferable Minimum 5-10 years of experience in pharmaceuticals and must have 5 years of experience in Analytical testing 5 years QC experience in Generic Pharmaceutical industries would be preferable Experience in a cGMP environment is required Experience with dermatological, transdermal, and/or inhaled dosage forms is preferable Knowledge and use of Good Documentation practices Knowledge of USP/ICH/FDA guidelines Ability to learn quickly and having decision making skills, QC Chemist B will perform a variety of QC testing to assess the strength, identity and purity of test samples and/or materials. Will work as a member of team to effectively plan and QC analytical testing using established (official and/or in-house) test procedures. The QC Chemist B may execute 90% - 100% of their work at the bench level. Perform assigned sampling, physical, chemical tests and assay on raw materials, active pharmaceutical ingredients, in-process, finished and stability products, using various wet chemicals, physical and instrumental techniques (HPLC, GC, UV-Vis, IR, Particle Size Analyzer, NGI cascade impactor, KF Auto titrator, Bulk Density, and other routine QC instruments) as per as per USP monograph / In-house / any other Compendial monographs. Work with supervisor to plan and make adequate inventory of test reagents and solutions to perform work, assure supplies are ordered as needed to perform assigned work. Work with supervisor to plan and execute testing to meet established time lines. Perform complicated testing with supervisory direction. Record data and results as specified in documentation procedures. Document work clearly and perform tests accurately. Prepare and/or Review Test Procedures, SOPs, and Protocols as assigned. Perform maintenance and calibrations of laboratory instruments/equipment with supervisory direction/training as needed. Perform troubleshooting and investigations under the direction of a supervisor. Comply with all regulatory/in-house requirements (may include but not limited to safety, house keeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity. Review of Analytical documents as required
