QC Validation Scientist

CordenPharma International; North Augusta (SC); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

CordenPharma International in North Augusta, SC seeks a QC Validation Scientist to validate analytical testing methodologies for raw materials, intermediates, and finished products. Relocation assistance is provided for candidates willing to relocate to the area.

Responsibilities include method transfer/verification/validation using HPLC/UPLC/GC, KF, and spectroscopy, adhering to GMP SOPs, and preparing validation reports.

Qualifications

• Bachelor or Master’s degree in Chemistry, life sciences, or related discipline.
• 5–7 years bench experience for Bachelor’s degree and 4–6 years for Master degree in a QC laboratory.
• Proficiency in MS Word and MS Excel.

Responsibilities

• Safely and effectively validate analytical testing methodologies for raw materials, intermediates, and final products.
• Perform transfer/verification/validation of test methods using HPLC, GC, KF, spectroscopy, and wet chemical testing.
• Investigate and resolve analytical issues within Analytical Development, method validation, and QC.
• Follow SOPs for Good Manufacturing Practices and prepare/ review technical documentation and validation reports.
• Identify out-of-specification results and report non-routine analytical problems.
• Maintain and troubleshoot analytical instrumentation; support method optimization and transfer.

Skills

Strong analytical skills

Excellent writing skills

MS Word / Excel proficiency

Education

Bachelor or Master in Chemistry or life sciences

Tools

HPLC

UPLC

GC

KF

Spectroscopy

LCMS

UHPLC

Job description

Now Hiring for QC Validation Scientist. We are located in North Augusta, SC, MUST be willing to relocate to the area. Relocation assistance is provided.

Primary Responsibilities:

• With minimal supervision, safely and effectively validate analytical testing methodologies used to control raw materials, production intermediates, and final products.
• Executes proficiency in transfer/verification/validation of test methods for pharmaceutical raw materials and finished products for strength, impurities, 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 and 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 Perform technical writing including documentation of test methods and method development and validation protocols, reports in compliance with FDA regulations. as well as Change controls.
• Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems.
• Maintains and troubleshoots 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 DP stability data tracking and trending.
• 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 team.
• Track all the sales order for method validation/Verification and transfer work on timely manner.
• Other duties as assigned by management.

Qualifications:

• Minimum Education: Bachelor or Master’s degree in Chemistry, life sciences, or related discipline.
• Minimum Laboratory Experience: 5-7 years for Bachelor’s degree and 4-6 years for Master degree of bench experience in a Quality control laboratory environment.
• Proficiency in use of software including Microsoft Word and Microsoft Excel.
• Method development experience is a plus.
• Empower 2 or 3 software proficiency is preferred.

Good communication and writing skills.

ADA-These Requirements are a Condition of Employment:

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