Visual Inspection Technician

Revelation Pharma; Hoover (AL); Vor Ort; USD 40.000 - 55.000; Vollzeit

Zusammenfassung

Revelation Pharma located in Hoover, Alabama is seeking a Visual Inspection Technician for a 503B Outsourcing Facility. This technician will conduct visual inspections of compounded pharmaceutical products and ensure compliance with FDA guidelines.

Qualified candidates will have a high school diploma and be licensed as a pharmacy technician. Familiarity with regulatory standards and the ability to work in a controlled environment are essential.

Qualifikationen

• Prior experience in pharmacy, healthcare, or manufacturing environment.
• Ability to perform visual inspection and categorize defects.
• Proficient in maintaining accurate records.

Aufgaben

• Perform visual inspection of unlabeled finished drug products.
• Label products according to regulations and perform post-labeling inspections.
• Adhere to safety protocols and participate in facility maintenance.

Kenntnisse

Attention to Detail

Effective Communication

Regulatory Knowledge

Collaboration

Ausbildung

High school diploma or equivalent

Licensed pharmacy technician in Alabama

Jobbeschreibung

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

The responsibilities listed below are subject to change.

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 requirements
• Perform post-labeling inspections

Quality 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-keeping

Safety and Facility Maintenance

• Follow safety protocols, including proper gowning, hand hygiene, and equipment sanitation
• Participate in routine facility cleaning schedules, ensuring a clean work environment
• Report any equipment malfunctions or safety concerns to supervisors
• Assist 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 certification

Physical 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.
• Able to work in a controlled environment
• Capable of lifting up to 40 pounds as needed.
• 20/20 vision (with or without corrective aids) required for visual inspection of drug products, in accordance with legal requirements.

KEY COMPETENCIES

• 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.