Granulation/Blending Technician

Katalyst CRO; Wilson (NC); Presencial; USD 42.000 - 63.000; Jornada completa

Descripción de la vacante

Katalyst CRO in Wilson, NC seeks a Pharmaceutical Technician to clean, set up, and operate machinery in a cGMP environment, ensuring adherence to SOPs and regulatory guidelines. The role focuses on ensuring accurate material handling, batch records, and quality inspections across oral solid dose processes.

Responsibilities include preparing materials, performing weight checks, operating equipment, and maintaining cleanrooms per SOPs, with emphasis on safety and precise documentation.

Formación

• Basic to complex mathematical computations
• Experience with oral solid dose manufacturing pref.
• Knowledge of cGMPs and SOPs

Responsabilidades

• Follow Master Batch Records for manufacturing of controlled, oral solid dose (OSD) and other dosage forms when required.
• Prepare raw materials, blends, and bulk accountability throughout manufacturing processes.
• Performs weight checks for incoming and dispensed materials ensuring compliance with established procedures.
• Identify, report, and resolve quality issues.
• Safely and in compliance with batch records and SOPs, set up, operate, and clean manufacturing equipment (OSD manufacturing may include rotor sieves, granulators, blenders, coaters, encapsulators, compression machines).
• Perform in-process testing and inspections as required by Master Batch Record (weighing, tablet thickness, tablet hardness, friability, visual inspection).
• Clean and sanitize manufacturing rooms including walls, floors, and ceilings per SOPs.
• Report accidents and unsafe conditions or unusual circumstances to supervisor.
• Complete accurate and timely documentation. Follow good documentation practices in accordance with GMP.
• Actively participate in Production team and Site communication meetings.
• Maintain regular and punctual attendance; work overtime as required.
• Support GMP investigations and events.
• Identify and report potential GMP impacting situations.
• Contribute to SOP writing in your technical area.

Conocimientos

Math skills

GMP knowledge

OSD manufacturing experience

Educación

High School Diploma or equivalent

Descripción del empleo

Job Description

The Pharmaceutical Technician will efficiently, effectively, and safely clean, set-up, and operate machinery in the manufacturing area while adhering to applicable cGMPs, SOPs, FDA, and DEA guidelines.

Job Description

The Pharmaceutical Technician will efficiently, effectively, and safely clean, set-up, and operate machinery in the manufacturing area while adhering to applicable cGMPs, SOPs, FDA, and DEA guidelines.

Primary Responsibilities

• Follow Master Batch Records for the manufacturing of controlled, oral solid dose (OSD) and other dosage forms when required.
• Prepare raw materials, blends, and bulk accountability throughout manufacturing processes.
• Performs weight checks for incoming and dispensed materials ensuring compliance with established procedures. Operates scales including set-up, verification, leveling and challenging.
• Identify, report, and resolve quality issues.
• Safely and in compliance with batch records and SOPs, set up, operate, and clean manufacturing equipment (oral solid dose manufacturing may include rotor sieves, granulators, blenders, coaters, encapsulators, compression machines, etc.).
• Perform in-process testing and inspections as required by Master Batch Record (weighing, tablet thickness, tablet hardness, friability, visual inspection, etc.).
• Clean and sanitize manufacturing rooms including walls, floors, and ceilings per SOPs.
• Report accidents and unsafe conditions or unusual circumstances to supervisor.
• Complete accurate and timely documentation. Follow good documentation practices in accordance with GMP.
• Actively participate in Production team and Site communication meetings.
• Maintain regular and punctual attendance; work overtime as required.
• Support GMP investigations and events.
• Identify and report potential GMP impacting situations.
• Contribute to Standard Operating Procedure (SOP) writing in your technical area.

Requirements

• High School Diploma or equivalent.
• Up to three years pharmaceutical industry experience preferred or an equivalent combination of education, demonstrated mechanical skill, and experience in a similar industry.

Necessary Knowledge, Skills, And Abilities

• General ability to perform basic to complex mathematical computations of addition, subtraction, multiplication, and division. Understanding of the Metric System of Measurement..
• Preferred experience in oral solid dose (OSD) pharmaceutical manufacturing Granulation/Blending and Bead Coating operations.