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Job Description – Visual Inspection Clerk (503B Compounding Industry)
Position Summary
The Visual Inspection (VI) Clerk supports the quality assurance and production teams in the inspection, documentation, and disposition of sterile injectables, hormone pellets, and container-closure systems. This role ensures compliance with FDA 503B outsourcing facility regulations, cGMP, USP standards ( ,
,
, etc.), and internal SOPs. The VI Clerk performs critical quality control functions to safeguard patient safety while assisting with ancillary non-technician tasks in support of daily operations. This is a full time in person position M-F in Irving, TX.
Key Responsibilities
Visual Inspection of Sterile Injectables • Perform 100% manual visual inspection of filled vials, syringes, and IV bags for particulate matter, container integrity, cosmetic defects, and proper fill levels. • Operate under validated lighting conditions and time limits as defined by PDA and internal SOPs. • Document inspection outcomes, segregating conforming and non-conforming units according to quality standards. • Escalate critical or recurring defects to Quality Assurance or Area Supervisor/Manager.
Hormone Pellet Inspection • Inspect pressed hormone pellets for size, weight, shape, and surface integrity per established specifications. • Document acceptance/rejection results in batch records and logbooks. • Assist in packaging preparation under controlled conditions.
Container-Closure System Oversight • Inspect vials, stoppers, and seals prior to use for cleanliness and defects. • Verify container-closure integrity post-processing using approved inspection methods.
Documentation & Compliance • Complete real-time data entry in batch records, inspection logs, and quality forms. • Maintain GDP compliance (legible, contemporaneous, attributable records). • Participate in deviation reporting and provide inspection-related input for investigations.
Other Support Tasks • Stage components, supplies, and inspection tools for daily operations. • Perform equipment cleaning, calibration checks, and inspection station setup. • Provide clerical support such as filing, logbook maintenance, and controlled document handling.
Qualifications • High school diploma or equivalent required; Associate’s degree or higher . • Prior experience in a cGMP or 503B/503A compounding environment . • Knowledge of aseptic processing, sterile drug products, or hormone pellet manufacturing desirable. • Strong attention to detail and ability to work in controlled environments. • Ability to read and follow SOPs, quality standards, and regulatory requirements. • Comfortable with repetitive tasks under defined lighting/time conditions.
Competencies •
Regulatory Compliance : Familiarity with cGMP, FDA 503B guidance, and USP chapters. •
Attention to Detail : Consistently identifies product defects and maintains accuracy in records. •
Collaboration : Works effectively with QA, Production, and Packaging staff. •
Adaptability : Supports both inspection duties and ancillary operational tasks. •
Quality Mindset : Prioritizes patient safety and product quality in all activities.
Physical & Environmental Requirements • Ability to sit/stand for extended inspection sessions (per PDA time-limit guidance). • Manual dexterity for handling small units (vials, syringes, pellets). • Work in cleanroom gowning environments (ISO-classified areas). • Tolerance for repetitive tasks under bright inspection lighting.
Company DescriptionWe specialize in compounding office-use and personalized prescription medications.Company DescriptionWe specialize in compounding office-use and personalized prescription medications.
Job Description – Visual Inspection Clerk (503B Compounding Industry)
Position Summary
The Visual Inspection (VI) Clerk supports the quality assurance and production teams in the inspection, documentation, and disposition of sterile injectables, hormone pellets, and container-closure systems. This role ensures compliance with FDA 503B outsourcing facility regulations, cGMP, USP standards ( ,
,
, etc.), and internal SOPs. The VI Clerk performs critical quality control functions to safeguard patient safety while assisting with ancillary non-technician tasks in support of daily operations. This is a full time in person position M-F in Irving, TX.
Key Responsibilities
Visual Inspection of Sterile Injectables • Perform 100% manual visual inspection of filled vials, syringes, and IV bags for particulate matter, container integrity, cosmetic defects, and proper fill levels. • Operate under validated lighting conditions and time limits as defined by PDA and internal SOPs. • Document inspection outcomes, segregating conforming and non-conforming units according to quality standards. • Escalate critical or recurring defects to Quality Assurance or Area Supervisor/Manager.
Hormone Pellet Inspection • Inspect pressed hormone pellets for size, weight, shape, and surface integrity per established specifications. • Document acceptance/rejection results in batch records and logbooks. • Assist in packaging preparation under controlled conditions.
Container-Closure System Oversight • Inspect vials, stoppers, and seals prior to use for cleanliness and defects. • Verify container-closure integrity post-processing using approved inspection methods.
Documentation & Compliance • Complete real-time data entry in batch records, inspection logs, and quality forms. • Maintain GDP compliance (legible, contemporaneous, attributable records). • Participate in deviation reporting and provide inspection-related input for investigations.
Other Support Tasks • Stage components, supplies, and inspection tools for daily operations. • Perform equipment cleaning, calibration checks, and inspection station setup. • Provide clerical support such as filing, logbook maintenance, and controlled document handling.
Qualifications • High school diploma or equivalent required; Associate’s degree or higher . • Prior experience in a cGMP or 503B/503A compounding environment . • Knowledge of aseptic processing, sterile drug products, or hormone pellet manufacturing desirable. • Strong attention to detail and ability to work in controlled environments. • Ability to read and follow SOPs, quality standards, and regulatory requirements. • Comfortable with repetitive tasks under defined lighting/time conditions.
Competencies •
Regulatory Compliance : Familiarity with cGMP, FDA 503B guidance, and USP chapters. •
Attention to Detail : Consistently identifies product defects and maintains accuracy in records. •
Collaboration : Works effectively with QA, Production, and Packaging staff. •
Adaptability : Supports both inspection duties and ancillary operational tasks. •
Quality Mindset : Prioritizes patient safety and product quality in all activities.
Physical & Environmental Requirements • Ability to sit/stand for extended inspection sessions (per PDA time-limit guidance). • Manual dexterity for handling small units (vials, syringes, pellets). • Work in cleanroom gowning environments (ISO-classified areas). • Tolerance for repetitive tasks under bright inspection lighting.
Company DescriptionWe specialize in compounding office-use and personalized prescription medications.Company DescriptionWe specialize in compounding office-use and personalized prescription medications.