QC INVESTIGATOR

Aurobindo Pharma USA, Inc.•Durham, NC

36d•Onsite

About The Position

The QC Investigator is responsible for conducting thorough, scientific, and compliant investigations of laboratory-related deviations, including OOS (Out of Specification), OOT (Out of Trend), atypical results, and laboratory incidents. The role ensures investigations are performed in alignment with regulatory requirements (FDA, MHRA, EU GMP) and internal SOPs to determine root causes, assess impact, and implement effective CAPA.

Requirements

Excellent technical writing skills, communication skills, organization skills.
3–8 years of experience in QC within pharmaceutical industry.
Minimum 2–3 years in handling OOS/OOT investigations.
For BS, up to 5 years in a regulated pharmaceutical industry preferably in QC.
For MS or higher degree, up to 3 years in a regulated pharmaceutical industry preferably in QC.
Must be proficient with pharmaceutical drug manufacturing processes, cGMPs and other regulatory requirements.
Experience in conducting, writing non-conformance investigations, root cause analyses, and identifying corrective actions.
Experience in CAPA resolution and review of change Controls, SOPs, protocols/reports and quality indicator review.

Nice To Haves

MDI investigations experience preferred.

Responsibilities

Lead and conduct investigations for OOS (Out of Specification) results
Lead and conduct investigations for OOT (Out of Trend) results
Lead and conduct investigations for Atypical/aberrant results
Lead and conduct investigations for Laboratory incidents and deviations
Follow a structured investigation approach as per site SOP.
Writing the investigation Protocol and reports.
Ensure timely closure of investigations within defined timelines.
Define and recommend Corrective and Preventive Actions (CAPA).
Track CAPA effectiveness and ensure timely closure.
Responsible for closure of all QAMS documents on time
Responsible for maintain GPL in laboratory
Management of Standards / Column /Chemical in laboratory
Review analytical data, chromatograms, spectra, and raw data.
Identify analytical errors, instrument failures, or method-related issues.
Support method troubleshooting and improvement.
Other responsibilities assigned by Director QC on routine basis

Benefits

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