QC Validation Scientist

About the role

Location: North Augusta, SC. Must be willing to relocate to the area; relocation assistance is provided.

Responsibilities

• With minimal supervision, safely and effectively validate analytical testing methodologies used to control raw materials, production intermediates, and final products.
• Execute proficiency in transfer, verification, and validation of test methods for pharmaceutical raw materials and finished products for strength, impurities, and identity by HPLC, GC, dissolution, KF, spectroscopy, and traditional quantitative analysis, utilizing HPLC, UPLC, GC, KF, spectroscopy, and/or traditional wet chemical testing under general supervision.
• Investigate and solve analytical technical issues within Analytical Development, analytical method validation, Process Support Group, and Quality Control.
• Become familiar with, and adhere to, requirements as documented in SOPs for Good Manufacturing Practices.
• Prepare and review technical writing including documentation of test methods, method development and validation protocols, and reports in compliance with FDA regulations, as well as change controls.
• Recognize and report out-of-specification or unexpected results and non-routine analytical and product problems.
• Maintain and troubleshoot analytical instrumentation as needed.
• Support method optimization, transfer, and validation activities.
• Support routine R&D analysis of quality control testing for drug substances and drug product by using GC, HPLC, LCMS, IC, and UHPLC.
• Support QA for drug product stability data tracking and trending.
• Qualify reference materials.
• Assist the QC group with writing and editing of deviations, CAPA, OOS, and OOT.
• Develop teamwork and communication skills through active listening and honest dialog with peers and supervisors.
• Communicate effectively with internal team personnel as well as external teams.
• Track all sales orders for method validation, verification, and transfer work in a timely manner.
• Other duties as assigned by management.

Qualifications

• Minimum Education: Bachelor's or Master's degree in Chemistry, life sciences, or related discipline.
• Minimum Laboratory Experience: 5–7 years for Bachelor's degree; 4–6 years for Master's degree of bench experience in a Quality Control laboratory environment.
• Proficiency in Microsoft Word and Microsoft Excel.
• Good communication and writing skills.
• Method development experience is a plus.
• Empower 2 or 3 software proficiency is preferred.

Requirements

These requirements are a condition of employment:

• Must be able to push, pull, squat, stand, and walk throughout the day.
• Must be able to lift up to 40 lbs.
• Must be able to wear safety shoes and glasses throughout the day while in designated areas (provided by the company).
• Must be cleared by a physician to wear a respirator throughout the day while in designated areas.
• Must be able to work in a chemical environment.