Quality Assurance Specialist: CAPA & OOS/OOT

KVK Tech, Inc.; Newtown (PA); Presencial; USD 60.000 - 80.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401(k) with company match

Health, vision, and dental Insurance

Childcare expense reimbursement

Tuition reimbursement

Annual bonus eligibility

Annual merit increases

Paid Time Off and Flexible Holidays

Descripción de la vacante

Quality Assurance Associates in Newtown, PA seeks a QA Associate to review analytical data for raw materials, in-process materials, finished products, and stability samples using HPLC/UPLC and MOAs. You will design and maintain quality systems, including Deviations, CAPA, and Change controls in line with cGMP and FDA requirements.

The role requires a Bachelor's degree in Chemistry or Pharmaceutical Science and 1 year of related experience; MOA, Change Control, OOS/OOT, BMRs, APQR, and CAPA

Formación

• Bachelor's degree in Chemistry or Pharmaceutical Science required.
• 1 year of experience in quality assurance or related field required.
• Experience with MOA, Change Control, OOS/OOT, BMRs, APQR, and CAPA preferred.

Responsabilidades

• Review and verify analytical data for raw materials, in-process materials, finished products and stability samples using HPLC/UPLC and MOAs.
• Develop and maintain quality system elements including Deviations, CAPA management, and Change controls in compliance with cGMP and FDA.
• Prepare and initiate change controls to revise SOPs and related documents.
• Investigate reported OOS/OOT events.
• Review batch manufacturing records and support disposition activities.
• Prepare APQRs and track QMS metrics for management review.

Conocimientos

MOA

Change Control

OOS/OOT

BMRs

APQR

CAPA

Educación

Bachelor's degree in Chemistry or Pharmaceutical Science

Descripción del empleo

Quality Assurance Associates in Newtown, PA seeks a QA Associate to review analytical data for raw materials, in-process materials, finished products, and stability samples using HPLC/UPLC and MOAs. You will design and maintain quality systems, including Deviations, CAPA, and Change controls in line with cGMP and FDA requirements.

The role requires a Bachelor's degree in Chemistry or Pharmaceutical Science and 1 year of related experience; MOA, Change Control, OOS/OOT, BMRs, APQR, and CAPA