Job Description

The Visual Inspect QC Technician will be a part of the Quality Unit. The Visual Inspect QC Technician will be responsible for prioritizing batches for visual inspection with production and quality staff, completing visual inspection of batches within reasonable timeframes, appropriately classifying observed defects, and performing post-labeling inspections. The Visual Inspect QC Technician will also perform routine sampling and QC review of documentation.

DUTIES & RESPONSIBILITIES :

• Follows regulatory, cGMP, and USP guidelines as required by job function 
• Perform visual inspection of unlabeled finished drug products
• Classify observed defects into pre-defined categories
• Calculates percent defects on inspection results and reconciles components
• Proper documentation of visual inspection activities on associated compounding records in accordance with procedures, CGMP, and CGDP
• Perform post-labeling and packaging inspections
• Follow established protocols for documentation, reporting, and record-keeping
• Follow safety protocols, including proper gowning, hand hygiene, and equipment sanitation
• Participate in routine facility cleaning schedules, ensuring a clean work environment
• Performs regularly scheduled walk-throughs in the production areas such as formulation, sample/pre-weigh, and the filling room (production areas), as well as the Warehouse 
• Performs Environmental Monitoring of Class C production areas, including sample collection 
• Reviews line clearance and setup in production areas prior to the start of a new batch or operation
• Provides Quality approval and acceptance, including the release of raw materials, components, and finished products/preparations 
• Performs packaging and product label reviews, cleaning and maintenance log reviews, and assists with quality investigations 
• Collects retention sample and monitors drug storage requirements 
• Follows and trains others to comply with the company’s standard operating procedures (SOPs) 
• Completes other projects and duties as required and/or necessary 

EDUCATION AND/OR TRAINING :

• High school Diploma or GED from recognized institution or organization required 
• Associates degree in a scientific discipline or closely related technical field of study preferred
• Pharmacy Technician Certification preferred

WORK EXPERIENCE :

• 2 years prior experience in a pharmacy, healthcare, or manufacturing environment, especially in sterile compounding or quality preferred.

ADDITIONAL QUALIFICATIONS AND COMPETENCIES (OPTIONAL):

• Attention to Detail: Effective organization skills, attention to detail, and the maintenance of precise records.
• Regulatory Knowledge: Familiarity with FDA, cGMP, and USP <797> guidelines is a strong asset.
• Visual ability to detect defects (as demonstrated through competency assessments)
• Collaboration: Works well with cross-functional teams, including quality control, shipping, and pharmacists.
• Regulatory Compliance: Strong understanding of 503B regulations and dedication to following all facility protocols.
• Quality-driven, results oriented, and strong attention to detail 
• Proven organizational and time management skills 
• Aptitude for decision-making and performing risk assessments 
• Good computer skills with basic knowledge of Microsoft based programs 

PHYSICAL REQUIREMENTS:

• Ability to sit or stand for extended periods.
• Capable of lifting up to 40 pounds as needed.
• 20/20 vision (with or without corrective aids) required for visual inspection, in accordance with legal requirements.

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