Chemist C

Aurobindo Pharma USA, Inc.•Durham, NC

About The Position

Responsible for ensuring compliance with Good Laboratory Practices (GLP), cGMP requirements, and internal quality standards within the Quality Control laboratory. Oversees laboratory compliance activities, including review of analytical documentation, data integrity verification, laboratory audits, investigations (OOS/OOT/Deviations), CAPA management, and regulatory inspection readiness. Supports the implementation and continuous improvement of quality systems and analyzes analytical samples (RM/PM/SFG/FG/Stability).

Requirements

Minimum 4–6 years of experience in pharmaceuticals.
3–5 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.
Minimum bachelor's degree in a scientific field.

Nice To Haves

Three years of QC experience in generic pharmaceutical industries is preferable.
A bachelor's degree with Chemistry as one of the subjects is preferable.

Responsibilities

Ensure compliance with GLP, cGMP, data integrity, and applicable regulatory requirements.
Review and maintain laboratory documentation, including analytical worksheets, logbooks, instrument usage records, and software audit trails.
Perform periodic laboratory audits and identify gaps related to GLP compliance.
Support or perform investigations related to OOS, OOT, deviations, and CAPA.
Review analytical data for completeness, accuracy, and compliance with ALCOA+ principles.
Manage laboratory documentation systems and ensure timely archival and retrieval of records.
Participate in preparation for and support regulatory inspections, customer audits, and internal audits.
Review laboratory equipment qualification, calibration, and maintenance records for compliance.
Monitor laboratory housekeeping and maintain compliance status of laboratory areas.
Track and trend laboratory compliance metrics and prepare periodic quality reports.
Collaborate with QA, QC, Manufacturing, and Regulatory Affairs to ensure regulatory compliance.
Ensure timely closure of investigations, CAPAs, and change controls related to laboratory activities.
Review and approve laboratory documents, protocols, reports, and compliance assessments as assigned.
Analyze RM, PM, SFG, FG, and stability samples.
Perform calibration of laboratory instruments.
Manage primary and secondary standards in the laboratory.

Benefits

Medical and prescription benefits with a choice of four medical plans through Horizon; prescription benefits are provided automatically with medical benefits.
Dental benefits with three plan options through CIGNA.
Vision plan with two plan options through VSP.
Basic Life and AD&D, and Supplemental Life Insurance.
Voluntary Short-Term Disability, State Disability, and Long-Term Disability.
Flexible Spending Accounts for health care and dependent care.
Health Savings Account.
401(k) plan through Fidelity with employer match; fully vested after 3 years.
Employee Assistance Program, 100% confidential and company paid.
Critical Illness and Accidental Insurance.
Legal and Identity Theft Insurance.
Paid vacation, PTO, and holidays.