QC Analyst

Role 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, while ensuring quality, safety, efficacy, and regulatory compliance. Location: Raleigh, NC.

Responsibilities

• 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.

Qualifications

• Required: Bachelor’s Degree in a Scientific field from an accredited university.
• Required: Minimum one year of experience in the pharmaceutical industry.
• Preferred: Experience with USP, CFR, ICH, and ISO regulations and guidelines as well as Quality by Design (QbD) principles.
• Preferred: Hands-on experience of running KF, HIAC, pH meters, Polarimeter, FT-IR, and various other lab equipment.
• Required: Experience in relevant laboratory, computer, and data analysis skills.
• Preferred: NMR experience.
• Required: Strong organizational abilities and problem-solving skills.

Skills

• Knowledge of quality system methodologies, such as Failure Mode Effect Analysis and Pareto Analysis, and understanding of Six Sigma concepts.
• Ability to handle a wide variety of tasks under critical time constraints.
• Ability to work independently and in a group setting, with collaboration, self-motivation, proactivity, and critical thinking.
• Ability to work a varied schedule at agreed upon times, including potential weekends, early mornings, or late evenings if required.