Chemist C

Aurobindo Pharma USA, Inc.; Durham (NC); On-site; USD 80,000 - 89,000; Full time

Benefits offered by this job

Medical plans

Dental plans

Vision plans

Life Insurance

Disability Insurance

FSA

HSA

401(k) Plan with match

EAP

Job summary

Aurolife seeks a QC Chemist C to perform analytical testing and stability studies, ensuring GLP status in the lab and adherence to regulatory requirements. The role focuses on bench work 80–100% with rigorous data review and documentation.

The ideal candidate has 5+ years in pharmaceuticals, experience in cGMP environments, and familiarity with EMPOWER/LIMS. Inhalation testing experience is preferred; flexible hours may be required.

Qualifications

• BS or MS in Chemistry or Pharmaceutical Sciences, or related field.
• Minimum 5+ years of experience in Pharmaceuticals and Analytical testing.
• Preference shall be given for experience in Inhalation testing on a variety of Inhalation products.

Responsibilities

• Perform in-process, finished product and stability testing using wet chemistry and instrumental techniques (HPLC, UPLC, GC, UV-Vis, IR, Particle Size Analyzer, KF titrator, Bulk Density).
• Plan and execute testing to meet timelines with minimal supervision.
• Assist with preparation or review of Test Procedures, SOPs, Protocols, and CoAs.
• Record data clearly and ensure tests are accurate.
• Maintain calibration of laboratory instruments with minimal direction.
• Assist in troubleshooting and investigations.
• Draft deviation reports as assigned.
• Comply with safety, cGMP, cGLP and documentation requirements.
• Review analytical documents; investigate OOS/OOT deviations.

Skills

EMPOWER/LIMS

QC in generics

cGMP environment

Good Documentation

USP/ICH/FDA guidelines

Team player

Flexible hours

Fast learner

Education

BS or MS in Chemistry or Pharmaceutical Sciences

Job description

Division Overview

Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical product 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

QC Chemist C will perform a variety of QC testing to assess the strength, identity and purity of test samples and/or materials. The role will work as a member of the stability team to effectively execute QC analytical testing using established (official and/or in‑house) test procedures. This role will entail 80–100% of work performed at the bench level. The successful candidate will be responsible for review of analytical documents, investigations, and maintain GLP status in the lab.

Responsibilities

• Perform assigned in‑process, finished product and stability product testing, using various wet chemistry, physical and instrumental techniques (HPLC, UPLC, GC, UV‑Vis, IR, Particle Size Analyzer, KF Auto titrator, Bulk Density, and other routine QC instruments) as per Finished Product methods.
• Independently plan and execute testing to meet established timelines; perform complicated testing with little supervisory direction.
• Assist with the preparation or review of Test Procedures, SOPs, Protocols, and CoAs as assigned.
• Record data and results as specified in documentation procedures. Document work clearly and perform tests accurately.
• Perform maintenance and calibrations of laboratory instruments/equipment with little supervisory direction/training.
• Perform troubleshooting and investigations under the direction of a supervisor.
• Assist in drafting deviation reports as assigned.
• Comply with all regulatory/in‑house requirements (including but not limited to safety, housekeeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity.
• Review analytical documents.
• Investigate OOS/OOT/Deviation and other lab related events.

Qualifications – Skills & Requirements

• Knowledge of EMPOWER Chromatography Data System and LIMS.
• QC experience in Generic Pharmaceutical industries is preferable.
• Experience in a cGMP environment is required.
• Knowledge and use of Good Documentation practices.
• Knowledge of USP/ICH/FDA guidelines.
• Team player who will assist junior colleagues.
• Willing to work flexible hours to meet product deliverables.
• Ability to learn quickly and have decision‑making skills that adhere to regulatory practices is required.

Education & Experience

• BS or MS in Chemistry or Pharmaceutical Sciences, or related field.
• Minimum 5+ years of experience in Pharmaceuticals and Analytical testing is desirable.
• Preference shall be given for experience in Inhalation testing on a variety of Inhalation products.

Benefits

• Medical and Rx benefits: choice of four medical plans through Horizon. Rx automatically provided with medical benefits.
• Dental benefits: three dental plan options through CIGNA.
• Vision plan: 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.
• Flexible Spending Accounts (FSA) – Both Health Care & Dependent Care Available.
• Health Savings Account (HSA).
• 401(k) Plan – Through Fidelity with Employer Match; fully vested after 3 years.
• Employee Assistance Program (EAP) – 100% Confidential and company paid.
• Critical Illness and Accidental Insurance.
• Legal and Identity Theft Insurance.
• Paid Time Off: Paid vacation, PTO, Holiday.

Compensation

USD 80,000.00 per year – 89,000.00 per year.

Physical Requirements

• 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.

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.