QC INVESTIGATOR

Job Overview

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.

Responsibilities

• Lead and conduct investigations for: OOS (Out of Specification) results, OOT (Out of Trend) results, Atypical/aberrant results, 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.
• Manage 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.

Qualifications & 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.
• MDI investigations experience preferred.

Skills & 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.

Benefits

• Medical Benefits
• Rx Benefits
• Dental Benefits
• Vision Plan
• Life Insurance
• Disability Insurance
• FSA (Flexible Spending Accounts)
• HSA (Health Savings Account)
• 401(k) Plan
• Employee Assistance Program (EAP)
• Critical Illness and Accidental Insurance
• Legal and Identity Theft Insurance
• Paid Time Off

Physical Requirements

• Office Position - While performing the duties of this job the employee is required to: Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment
• Specific vision abilities required by this job include close vision requirements due to computer work
• Light to moderate lifting is required
• Moderate noise (i.e. business office with computers, phone, and printers, light traffic).
• Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body.
• Sedentary work involves sitting most of the time.
• Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
• No additional requirements