Chemist A

Aurobindo Pharma USA, Inc.•Durham, NC

About The Position

The Chemist performs quality-control testing to assess the strength, identity, and purity of samples and materials. As part of a team, the Chemist plans and conducts analytical testing using established official and/or in-house procedures. The role may involve performing 90%–100% of work at the bench level. Testing covers raw materials, active pharmaceutical ingredients, in-process materials, finished products, and stability products. The Chemist uses wet-chemical, physical, and instrumental techniques and follows applicable USP, in-house, and other compendial procedures. The position also includes maintaining supplies and laboratory instruments, documenting and reviewing analytical work, and complying with regulatory and internal requirements. Aurolife develops and manufactures generic pharmaceuticals, with a focus on solid oral dosage products. The company describes its aim as providing healthcare at economical prices.

Requirements

Minimum bachelor’s degree in a scientific field.
Minimum 1–3 years of experience in pharmaceuticals.
Knowledge of Good Documentation Practices.
Ability to learn quickly and make decisions.

Nice To Haves

Chemistry as one of the subjects in the bachelor’s degree is preferred.
1–2 years of analytical testing experience is desirable.
Quality-control experience in generic pharmaceutical industries is preferred.
Knowledge of USP, ICH, and FDA requirements.

Responsibilities

Perform assigned sampling, physical and chemical tests, and assays on raw materials, active pharmaceutical ingredients, in-process materials, finished products, and stability products using wet-chemical, physical, and instrumental techniques.
Use laboratory techniques and instruments including HPLC, GC, UV-Vis, IR, particle size analyzer, KF autotitrator, and bulk density equipment, following USP, in-house, or other compendial monographs.
Plan and maintain an adequate inventory of test reagents and solutions, and ensure supplies are ordered as needed.
Plan and execute testing independently to meet established timelines; perform complicated testing with supervisory direction.
Record data and results according to 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 and equipment with supervisory direction or training.
Perform troubleshooting and investigations under a supervisor’s direction.
Comply with applicable regulatory and in-house requirements, including safety, housekeeping, laboratory chemical waste, cGMP, cGLP, and documentation requirements.
Review analytical documents as required.

Benefits

Choice of four medical plans through Horizon; prescription benefits are provided automatically 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 insurance.
Long-term disability insurance.
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, described as 100% confidential and 100% company paid.
Critical illness and accidental insurance.
Legal and identity theft insurance.
Paid vacation, PTO, and holidays.