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Quality Control Lab Tech-Plough Center

Market Range: 06

Hiring Salary: $19.67/Hourly

JOB SUMMARY/ESSENTIAL JOB FUNCTIONS:  The Quality Control Lab Technician is responsible for quality control testing of raw source water, processing water, Reverse Osmosis (RO) water, and Water for Injection (WFI) for drug products to ensure regulatory compliance with the applicable Food and Drug Administration (FDA), State, Local, and quality standards. This position provides quality control support for environmental monitoring (EM), EM testing, site production activities by performing routine and some non-routine testing of raw materials, semi-finished and finished products. This position provides support for product shipping activities by analysis of shipments and assistance to site departments as needed to ensure product quality.

DUTIES AND RESPONSIBILITIES: 

Performs microbiological and wet chemistry testing on source water.
Processes and finishes product samples in accordance with Standard Methods and standard operating procedures and policies.
Maintains detailed and accurate documentation of analyses and inspections concerning incoming raw materials, water processing treatment equipment, and production processes.
Collaborates with production and maintenance departments on various projects as necessary and appropriate.
Assists with cleaning and sanitation (Clean-In-Place (CIP)) duties for the water processing equipment as necessary and appropriate.
Manages multiple tasks and priorities while maintaining detailed and accurate records, quality and safety standards.
Understands and uses processing and batching computer controls to effectively changeover duties related to analytical support and production lines as needed.
Assists the sterile manufacturing team with sterile component preparations and batch record preparations.
Assists the sterile manufacturing team in sterile drug product bulk compounding, fill line preparations, line clearances, change part dis-assembling, assembling, visual inspection, labeling, packaging and cGMP document and data verifications.
Performs other duties as assigned.

MINIMUM REQUIREMENTS:  

EDUCATION: High School Diploma or GED. (Bachelor’s Degree preferred.) (TRANSCRIPT REQUIRED)

EXPERIENCE: Two (2) years of college course work in Microbiology, Food Science, Biology, Chemistry, or related field, and one (1) year of experience working in a test laboratory conducting analytical testing; OR two (2) years 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 work weekends.