QC Analyst - Raleigh, NC

TITLE:

Title: QC Analyst

Reports To: QC Analytical Manager

Location: Raleigh, NC

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/Indivior. 

POSITION SUMMARY:

The QC Analyst role is a key position within the QC team supporting the startup of the GMP manufacturing facility, through routine utility testing, wet chemistry methods and LIMS setup. This role will report to the QC Analytical Manager and will work in a collaborative team setting within the QC Department. This role is responsible for supporting and assisting with the delivery of the project timelines and critical milestones. This role will work in a manner that assures quality, safety, efficacy, and compliance with regulatory requirements.

ESSENTIAL FUNCTIONS:

The responsibilities of this role include, but are not limited to, the following:

· Support technology transfer to the manufacturing site by performing method verifications and transfers for the QC Laboratory.

· Perform and review instrument qualifications and ensure calibrations are completed.

· Perform plant utility testing including TOC, Conductivity and pH.

· Assist in setting up data for the implementation of LIMS for the QC department.

· Perform analyses and complete peer reviews.

· Assist in the shipping of samples off site to Contract Test Laboratories (CTL).

· Author, revise, and implement documentation such as standard operation procedures for the QC Laboratory.

· Support the evaluation of test methods and the adaptation of processes and techniques for commercial purposes.

· Keep accurate documentation as per current Good Manufacturing Practices (cGMP) and ALCOA principles.

· Identify and document deviations.

· Any other duties as determined by management to support the QC team.

MINIMUM QUALIFICATIONS:

· Bachelor’s Degree in a Scientific field from an accredited university required.

· Minimum one (1) year of experience in the pharmaceutical industry required.

· Experience with USP, CFR, ICH, and ISO regulations and guidelines as well as Quality by Design (QbD) principles is preferred.

· Hands-on experience of running KF, HIAC, pH meters, Polarimeter, FT-IR, and various other lab equipment is a plus.

· Experience in relevant laboratory, computer, and data analysis skills required.

· NMR experience is preferred but not required.

· Strong organizational abilities and problem-solving skills.

COMPETENCIES/CONDUCT:

In addition to the minimum qualifications, the employee will demonstrate:

· Knowledge of quality system methodologies, such as Failure Mode Effect Analysis, Pareto Analysis and understand Six Sigma concept.

· Ability to handle a wide variety of tasks under critical time constraints.

· Ability to work independently and in a group setting, collaborative, self-motivated, proactive, and critical thinking.

· Ability, at agreed upon times, to work a varied schedule with some potential weekend, early morning, or late evening hours, if required.