Quality Assurance Associate

KVK Tech, Inc.; Pennsylvania; Presencial; USD 60.000 - 75.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401(k) with company match

Health, vision, and dental Insurance

Annual merit increases

Paid Time Off and Flexible Holidays

Descripción de la vacante

KVK Tech, Inc. in Newtown, PA is seeking a Quality Assurance Associate to review and verify analytical data for raw materials, in-process materials, finished products and stability samples using HPLC/UPLC and approved MOAs.

The role involves Deviations, CAPA management, Change controls, and investigations of OOS/OOT in compliance with cGMP and FDA requirements. The candidate will also review BMRs, support disposition activities, and prepare APQRs and QMS metrics for management review, while

Formación

• Bachelor’s degree in Chemistry or Pharmaceutical Science plus 1 year experience.
• Experience with MOA, Change Control, OOS/OOT, BMRs, APQR, and CAPA.

Responsabilidades

• Review and verify analytical data for raw materials, in-process materials, finished products and stability samples using HPLC/UPLC and MOAs.
• Analyze, design, and develop quality system elements including Deviations, CAPA management systems and Change controls in compliance with cGMP and FDA.
• Prepare and initiate change controls to revise SOPs.
• Conduce investigations for reported OOS/OOT.
• Review batch manufacturing records (BMRs) and support disposition activities.
• Prepare APQRs and QMS metrics for management review and maintain laboratory instruments per FDA requirements.

Conocimientos

MOA

Change Control

OOS/OOT

BMRs

APQR

CAPA

Educación

Bachelor's degree in Chemistry or Pharmaceutical Science

Herramientas

HPLC/UPLC

Descripción del empleo

Quality Assurance Associates (Newtown, PA) – Review and verify the analytical data for Raw materials, in-process materials, finished products and stability samples using HPLC/UPLC and approved Method of Analysis (MOAs); Analyze, design, and develop quality system elements including Deviations, CAPA management systems and Change controls in compliance with cGMP and FDA; Prepare and initiate change controls to revise the SOP’s; Conduct the investigations for reported Out-of-Specification (OOS)/Out-of-Trend (OOT); Review batch manufacturing records (BMR’s) and support disposition activities; Prepare Annual Product Quality Reviews (APQRs) and QMS metrics for management review and maintain laboratory instruments in compliance with cGMP/cGLP and applicable FDA requirements.

Must have a Bachelor’s degree in Chemistry or Pharmaceutical Science plus 1 year experience in job offered. Require skills and knowledge of MOA, Change Control, OOS/OOT,batch manufacturing records/BMRs, APQR,CAPA.

What we offer:

• 401(k) with company match
• Health, vision, and dental Insurance
• Annual merit increases
• Paid Time Off and Flexible Holidays

MADE IN AMERICA

All KVK Tech products are made in the USA in strictest accordance with FDA, DEA, and DEP guidelines.