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:
Chemist B is responsible for ensuring that products and materials meet established quality standards and regulatory requirements by conducting laboratory tests, analyzing results, and maintaining accurate documentation. They perform testing on raw materials, in-process samples, and finished goods using various analytical techniques, while adhering to standard operating procedures (SOPs), Standard test procedure and Good Manufacturing Practices (GMP). QC Analysts also investigate discrepancies such as out-of-specification results, support corrective actions, maintain laboratory equipment, and ensure compliance with regulatory guidelines. This role requires strong attention to detail, technical expertise, and the ability to work in regulated environments.
Responsibilities:
Perform physical, chemical and instrumental tests 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, KF Auto titrator, Bulk Density, and other routine QC instruments) as per as per USP monograph / In-house / any other Compendial monographs.
Independently plan and make adequate inventory of test reagents and solutions to perform work, assure supplies are ordered as needed to perform assigned work.
Independently 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/equipments with supervisory direction/training.
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:
- 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
Education & Experience:
Minimum BS with Scientific field
BS with Chemistry is one of the subjects preferred
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
Notice to Recruitment Agencies:
Please note that we are not accepting unsolicited resumes or proposals from recruitment firms or agencies for this position. Thank you for your understanding.
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. Additional Physical Requirements:
No Additional Requirements
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.
