QA Specialist: Document Control & Batch Release

Millipore Corporation; Indianapolis (IN); Presencial; USD 69.000 - 111.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Paid time off (PTO)

Retirement contributions

Other prerequisites

Descripción de la vacante

MilliporeSigma is seeking a Quality Assurance professional to perform quality document control and product release activities in a parenteral manufacturing environment. You will review Batch Manufacturing Records, ensure GDP compliance, and collaborate with QA, QC, Operations, clients, and suppliers to meet regulatory requirements.

The role requires 2+ years of GMP QA experience; a Bachelor’s degree is preferred. Strong communication skills and ability to work autonomously are essential.

Formación

• 2+ years of quality assurance experience within GMP regulated environment.
• High School Diploma or GED required.
• Knowledge of cGMPs and GDP/documentation practices.
• Ability to operate autonomously and collaborate with others.
• Excellent written and verbal communication skills.
• Bachelor's Degree preferred.

Responsabilidades

• Perform thorough review of Batch Manufacturing Records and cGMP documents for commercial drug product lots.
• Evaluate batch records for accuracy, legibility, proper documentation practices and compliance.
• Identify errors and communicate corrections with Manufacturing per GDP requirements.
• Initiate deviations and investigations in the eQMS for batch record discrepancies.
• Drive continuous improvement in documentation quality with feedback and retraining recommendations.
• Track and report batch record review cycle times for on-time lot disposition.
• Maintain knowledge of product manufacturing processes and controls to support batch record review.

Conocimientos

Strong oral and written communication

Train and qualify others

Autonomy and collaboration

Educación

Bachelor's Degree

High School Diploma or GED

Herramientas

eQMS

Descripción del empleo

MilliporeSigma is seeking a Quality Assurance professional to perform quality document control and product release activities in a parenteral manufacturing environment. You will review Batch Manufacturing Records, ensure GDP compliance, and collaborate with QA, QC, Operations, clients, and suppliers to meet regulatory requirements.

The role requires 2+ years of GMP QA experience; a Bachelor’s degree is preferred. Strong communication skills and ability to work autonomously are essential.