Quality Control Lab Technician-Plough Center

Memphis, TN - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Description

Market Range: 08

Hiring Salary: $21.69/Hourly

JOB SUMMARY/ESSENTIAL JOB FUNCTIONS: The Quality Control Lab Technician supports all aspects of QC operations in a cGMP pharmaceutical manufacturing environment. This role performs routine and non-routine testing of raw materials in-process samples finished drug products water systems (source water process water RO water WFI) and environmental monitoring samples to ensure compliance with FDA USP and Plough Quality standards. The QC Lab Technician is responsible for accurate documentation data integrity investigation support and collaboration with manufacturing maintenance and quality teams. The position also supports sterile manufacturing activities product release processes and continuous improvement initiatives that uphold product quality regulatory compliance and operational efficiency.

Responsibilities

Conducts microbiological chemical and physical testing of source water RO water and WFI systems in accordance with cGMP FDA and USP requirements.
Performs routine and non-routine laboratory testing of raw materials in-process samples semi-finished and finished drug products following approved SOPs methods and specifications.
Executes environmental monitoring (EM) of controlled areas including viable and non-viable sampling surface sampling and personnel monitoring.
Maintains complete accurate and contemporaneous laboratory documentation in compliance with GDP and data integrity standards.
Processes prepares and analyzes product samples using standard wet chemistry microbiological and instrumental methods.
Collaborates with production engineering and maintenance to support investigations troubleshooting deviation resolutions and continuous improvement projects.
Supports the cleaning sanitation and verification of water systems and laboratory equipment including CIP activities when required.
Operates and maintains laboratory instrumentation ensuring calibration verification and appropriate usage logs are maintained.
Assists sterile manufacturing operations with sterile component prep environmental monitoring aseptic support activities and review of batch documentation.
Supports compounding filling line readiness line clearances equipment disassembly/assembly visual inspection labeling and packaging activities as needed in accordance with cGMP.
Understands and uses production and laboratory control systemsincluding batching systems LIMS and other electronic data systemsto support manufacturing and QC operations.
Manages multiple priorities while maintaining compliance with safety quality and documentation requirements.
Participates in shipping support activities by performing product sampling release testing and coordinating with other departments to ensure timely shipment.
Performs other QC and laboratory support duties as assigned.

Qualifications

MINIMUM REQUIREMENTS:

EDUCATION:Bachelors Degree.(Bachelors Degree preferred.)(TRANSCRIPT REQUIRED)

EXPERIENCE: One (1) year of experience working in a test laboratory conducting analytical testing.

KNOWLEDGE SKILLS AND ABILITIES:

Excellent analytical and problem-solving skills with strong written and oral communication skills.
Ability to follow instructions and work well with limited supervision both individually and as a team.
Understanding Food & Drug Safety principles and Current Good Manufacturing Practices (cGMP).
Understanding of Good Laboratory Practices (GLPs) and aseptic sampling and handling techniques to collect samples for microbiological analysis.
Experience operating under a quality management system or another regulated environment is desirable.

WORK SCHEDULE:This position may occasionally be required to workweekends.

Required Experience:

DescriptionMarket Range: 08Hiring Salary: $21.69/HourlyJOB SUMMARY/ESSENTIAL JOB FUNCTIONS: The Quality Control Lab Technician supports all aspects of QC operations in a cGMP pharmaceutical manufacturing environment. This role performs routine and non-routine testing of raw materials in-process samp...