QC INVESTIGATOR

Acrotech Biopharma Inc; Durham (NC); On-site; USD 75,000 - 90,000; Full time

Benefits offered by this job

Medical and Rx Benefits

Dental Benefits

Vision Plan

401(k) Plan

Job summary

Acrotech Biopharma Inc. is seeking a QC Investigator to conduct scientific investigations of laboratory deviations, including OOS, OOT, and atypical results, ensuring alignment with FDA, MHRA, EU GMP and SOPs.

The role involves root-cause analysis, CAPA implementation, and timely closure of QAMS documents. Qualifications include 3–8 years in QC within pharma, with 2–3 years in OOS/OOT investigations; MDI experience is a plus.

Qualifications

• Excellent technical writing skills, communication skills, and organization skills.
• 3–8 years of experience in QC within the pharmaceutical industry.
• Minimum 2–3 years handling OOS/OOT investigations.
• MDI investigations experience preferred.

Responsibilities

• Lead and conduct investigations for OOS, OOT, atypical results, and laboratory incidents.
• Follow a structured investigation approach per site SOP.
• Write the investigation protocol and reports.
• Ensure timely closure of investigations within defined timelines.
• Define and recommend CAPA; track CAPA effectiveness and closure.
• Review analytical data, chromatograms, spectra, and raw data.

Skills

Technical writing

Communication

Organization

OOS/OOT investigations

Quality systems

Education

BS in pharmaceutical science/related field

MS or higher degree in related field

Job description

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.
• Write 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 maintaining 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.
• Perform other responsibilities assigned by Director QC on a routine basis.

Qualifications and Skills

• Excellent technical writing skills, communication skills, and organization skills.
• 3–8 years of experience in QC within the pharmaceutical industry.
• Minimum 2–3 years handling OOS/OOT investigations.
• MDI investigations experience preferred.

Education and Experience

• 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.

Benefits

• Medical and Rx Benefits: choice of four medical plans through Horizon. Rx automatically provided with medical benefits.
• Dental Benefits: three dental plan options through CIGNA.
• Vision Plan: 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.

Compensation

Minimum: USD $75,000.00 / Yr.

Maximum: USD $90,000.00 / Yr.

Physical Requirements

• 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 for close vision tasks due to computer work.
• Light to moderate lifting is required.
• Moderate noise (business office with computers, phone, and printers, light traffic).
• Ability to sit at a computer terminal for an extended period of time; sedentary work exerts up to 10 pounds of force occasionally; negligible force frequently or constantly to lift, carry, push, pull or otherwise move objects; includes the human body. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

Blood/Fluid Exposure Risk

Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.