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Quality Control Technician - Day Shift

Location: Knoxville, TN, United States
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Description

RESPONSIBILITIES:
•    Performing all Quality Control inspection types as assigned by the Quality Control Supervisor (e.g., in-process & final QC inspections, WIP, pkg. and Raw material inspections, etc.)
•    Conducts first article and line clearance inspections of packaging lines
•    Conducts pre-weigh line clearance inspections prior to compounding/batching
•    Conducts compounding and filling equipment sanitization inspections
•    Maintains Retained FG, Bulk & Raw Material sample storage and logbooks 
•    Coordinates and arranges for finished product microbiological and other testing conducted by external laboratories 
•    Collect, store, test, and distribute samples and ensure prompt customer shipping.
•    Performs scale verification checks during the first article release
•    Initiate and lead Non-Conformances and support investigative work
•    Performs laboratory testing on bulk and finished products (as required)

•    Manages storage and cataloging of hardcopy batch and packaging records
•    Conducts and documents environment bioburden, particle testing, and cleaning validations of compounding and packaging equipment.  
•    Provides backup for incoming component packaging and raw material testing
•    Conduct training as needed
•    Must support all Safety initiatives at the site
•    Assist with administrative tasks such as filing and organizing documentation pertinent to Quality Control inspection
•    Shares ownership and performs the following as needed:
o    Line Clearance / First Article / In-Process Inspections
o    AQL Inspections – Level determined by Customer requirements
o    Finished Goods releases
o    Handling of Non-conforming material
•    May assist with CAPA, deviations, and non-conformance programs by collecting customer information, coordinating investigations across different departments, facilitating investigations, and entering information into the system. (as needed)
•    Performs other work-related duties as assigned by the Quality Control Supervisor
QUALIFICATIONS:
Required
•    Previous GMP and GDP experience and training
•    Flexibility to work overtime and weekends as scheduled
•    Problem Solving and decision-making.
•    Must be able to speak, write, and read English. Bilingual skills are a plus.
•    Minimum 3 years related experience in a manufacturing environment, preferably in a quality role.
•    Able to use standard inspection equipment (calipers, thickness gage, and other gages, etc.).
•    High school diploma or equivalent; technical degree is a plus.
 
Competencies:
•    Detail-oriented with good organizational skills.
•    Good communication and interaction skills.
•    Able to follow written work instructions.
•    Ability to work under minimal supervision.
•    Demonstrated ability to read, understand, and apply the information in technical documentation, procedures, and drawings and understand basic geometric tolerances.
•    Basic computer skills using Word and Excel.
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