Chemist B

Aurobindo Pharma USA, Inc.•Durham, NC

About The Position

The Chemist B performs sampling, testing, and analysis of raw materials, in-process materials, finished products, and stability samples according to approved specifications, test methods, and regulatory requirements. The role operates and maintains analytical instruments, documents and reviews analytical data, and ensures compliance with cGMP, cGLP, data integrity, and safety requirements. The position supports laboratory investigations, instrument calibration and maintenance, and the preparation and review of laboratory documents. It contributes to the timely release of materials and products while maintaining quality, accuracy, and regulatory compliance.

Requirements

Minimum 3–5 years of experience in pharmaceuticals.
2–4 years of experience in analytical testing.
Knowledge of Good Documentation Practices.
Knowledge of USP, ICH, and FDA requirements.
Ability to learn quickly and make decisions.

Nice To Haves

Experience in generic pharmaceutical industries is preferable.
A BS degree with Chemistry as one of the subjects is preferable.

Responsibilities

Perform sampling and routine or advanced physical, chemical, and instrumental analyses of raw materials, 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 complete assigned testing on time.
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.
Perform routine testing independently and support complex analyses under the guidance of senior staff or supervisors.
Report analytical results on time and notify appropriate personnel of atypical findings.
Record raw data, calculations, observations, and test results in controlled laboratory records and electronic systems.
Ensure documentation complies with Good Documentation Practices (GDP) and ALCOA+ data integrity principles.
Prepare, revise, and review analytical test procedures, SOPs, specifications, protocols, reports, and other laboratory documentation as assigned.
Perform routine calibration, verification, maintenance, and qualification of laboratory instruments and equipment according to approved procedures.
Maintain instrument logbooks and ensure equipment remains qualified and compliant.
Participate in investigations involving OOS, OOT, deviations, atypical results, and laboratory incidents.
Assist with troubleshooting analytical methods, instruments, and testing issues under supervisory guidance.
Support implementation of corrective and preventive actions (CAPA).
Review analytical data, laboratory notebooks, worksheets, chromatograms, calculations, and associated documentation.
Verify compliance with approved methods, specifications, and documentation requirements before reporting results.

Benefits

Choice of four medical plans through Horizon; prescription benefits are automatically provided with medical benefits.
Three dental plan options through CIGNA.
Two vision plan options through VSP.
Basic Life and AD&D and Supplemental Life Insurance.
Voluntary Short-Term Disability and State Disability.
Long-Term Disability and state short-term disability where applicable.
Health Care and Dependent Care Flexible Spending Accounts.
Health Savings Account.
401(k) plan through Fidelity with employer match; fully vested after 3 years.
Employee Assistance Program, confidential and company-paid.
Critical Illness and Accidental Insurance.
Legal and Identity Theft Insurance.
Paid vacation, PTO, and holidays.