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: 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.
- Completion of 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.
Benefits:
- Health care insurance (medical, dental, vision)
- Life Insurance
- Supplemental Insurance
- PTO
- 401K matching
- Sick leave
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Revelation Pharma is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.