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

Life Insurance

Disability Insurance

FSA/HSA

401(k) Plan

EAP

Legal Insurance

Paid Time Off

Job summary

Aurolife is seeking a QC Investigator to perform thorough investigations of laboratory deviations, including OOS, OOT, and atypical results, ensuring alignment with FDA/MHRA/EU GMP requirements and internal SOPs. You will write protocols and reports, drive timely closures, and implement CAPA with tracking of effectiveness.

Responsibilities include reviewing data, leading investigations, and maintaining QAMS and GPL in the lab.

Qualifications

• BS degree in a regulated pharmaceutical environment preferred.
• Experience in non-conformance investigations, root cause analyses and CAPA.
• Experience with cGMPs and regulatory requirements.

Responsibilities

• Lead and conduct investigations for OOS, OOT, and atypical results.
• Follow a structured investigation approach per site SOP.
• Write investigation protocols and final reports.
• Ensure timely closure of investigations within defined timelines.
• Define and implement corrective and preventive actions (CAPA).
• Track CAPA effectiveness and closures.
• Maintain QAMS documentation and laboratory GPL.
• Review analytical data, chromatograms, spectra, and raw data.
• Identify analytical errors or instrument/method issues.

Skills

Technical writing

Communication

Organization

QC experience

OOS/OOT investigations

MDI investigations

Education

BS in science

MS or higher in science

Job description

Division Overview

Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical product development and manufacturing. Aurolife has a 10 year history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has give Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.

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 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.

Qualifications – Skills & 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.

Education & 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 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.

Compensation

Min – USD $75,000.00/Yr.

Max – USD $90,000.00/Yr.

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). Ability to sit at a computer terminal for an extended period of time. 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.

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.