Job Description
Job Description
Role Summary
A Visual Inspection Technician in a 503B Outsourcing Facility plays a critical role in ensuring that compounded pharmaceutical products are accurately prepared and without defects. Visual inspection is the first of several post-production activities where filled compounded products are visually evaluated for product defects. This technician is responsible for working with production and quality staff to prioritize batches for visual inspection, completing visual inspection of batches within reasonable timeframes, appropriately classifying observed defects, and performing post-labeling inspections.
Job Activities and Responsibilities :
Post-Production Visual Inspection of Finished Drug Products
- 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
Labeling of Finished Drug Products
Label all products following facility and regulatory requirementsPerform post-labeling inspectionsQuality Assurance and Compliance
Adhere to FDA 503B guidelines, cGMP standards, and USP requirements to ensure product safety and quality.Follow established protocols for documentation, reporting, and record-keepingSafety and Facility Maintenance
Follow safety protocols, including proper gowning, hand hygiene, and equipment sanitationParticipate in routine facility cleaning schedules, ensuring a clean work environmentReport any equipment malfunctions or safety concerns to supervisorsAssist other process functions as required.
Qualifications and Education Requirements
Educational Background : High school diploma or equivalent; licensed as a pharmacy technician with the Alabama State Board of Pharmacy.Experience : Prior experience in a pharmacy, healthcare, or manufacturing environment, especially in sterile compounding or quality.Attention to Detail : Effective organization skills, attention to detail, and the maintenance of precise records.Complete inspection certificationPhysical Requirements :
Proficient in using a computer and related equipment, including printers and fax machines.Ability to sit or stand for extended periods.Effective communication skills via telephone and email.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.Working Requirements : Work Monday - Friday day shiftK EY C OMPETENCIES
Regulatory Knowledge : Familiarity with FDA, cGMP, and USPguidelines 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.Benefits :
Competitive Health Insurance options (medical, dental, vision)Company provided Life InsuranceSupplemental InsurancePaid Time Off (PTO)Retirement planning (401K, employer matching)Paid Sick LeavePaid Holidays
