QC Validation Scientist

Corden Pharma - A Full-Service CDMO; North Augusta (SC); In loco; USD 70.000 - 100.000; Tempo pieno

Descrizione del lavoro

Corden Pharma - A Full-Service CDMO in North Augusta, SC seeks a QC Validation Scientist to validate analytical methods and support QA for drug substances and products. Relocation to the area is required; relocation assistance is provided.

You will perform method validation/transfer using HPLC, GC, KF, and spectroscopy, prepare technical docs, and ensure FDA compliance. Strong writing and communication skills are essential.

Competenze

• 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.
• Good communication and writing skills.
• Method development experience is a plus.
• Empower 2 or 3 software proficiency is preferred.

Mansioni

• With minimal supervision, safely and effectively validate analytical testing methodologies used to control raw materials, production intermediates, and final products.
• Execute validation/transfer/verification of test methods for QA/QC using HPLC, GC, KF, spectroscopy, and related analytical techniques.
• Investigate and solve analytical technical issues within Analytical Development and QA.
• Prepare and review technical documentation and method development/validation protocols and reports compliant with FDA regulations.
• Maintain and troubleshoot analytical instrumentation and support method optimization and validation activities.
• Support routine R&D analysis and QA for stability data tracking and trending.

Conoscenze

Microsoft Word

Microsoft Excel

Communication skills

Writing skills

Method development

Empower 2 or 3

Formazione

Bachelor's degree in Chemistry, life sciences, or related discipline

Master’s degree in Chemistry, life sciences, or related discipline

Descrizione del lavoro

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.
• 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 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.

Good communication and writing skills.

• Method development experience is a plus.
• Empower 2 or 3 software proficiency is preferred.

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.