Quality Control Level 1

Hallandale Pharmacy•Fort Lauderdale, FL

10d

About The Position

The Quality Control Level 1, also known as Visual Inspection Quality Specialist, works in the Quality Assurance unit to help ensure the safety, purity, and quality of compounded sterile preparations (CSPs). The role operates in compliance with USP 797, USP 1790, 21 CFR 211.25, and internal standard operating procedures, and is primarily responsible for 100% visual inspection of filled vials, containers, and lyophilized products before pharmacy release. Inspections assess particulate matter, volume accuracy, container-closure integrity, and overall product quality. The specialist uses designated inspection equipment and techniques to assess product appearance and defects, including visual inspection of selected reconstituted samples. The role also documents and escalates rejections, separates passing and rejected products, and maintains a clean, organized, compliant inspection workstation. Work takes place in a cleanroom or QA laboratory environment and involves extended PPE use, prolonged sitting, and continuous handling of small vials.

Requirements

High school diploma or equivalent preferred.
Successful completion and documentation of Visual Inspection Video Training (Form 5.202.01) and didactic sterile training (SOP 2.101).
Excellent visual acuity, natural or corrected, with normal color perception.
Meticulous attention to detail to detect minute particulates, seal anomalies, and subtle cosmetic defects.
Ability to collaborate effectively with compounding technicians, QA/QC managers, and pharmacists, and escalate inconclusive visual findings to supervisors.
Ability to follow mandatory 30-minute eye-rest breaks.
Comfort wearing required PPE for extended periods in a cleanroom or QA laboratory environment.
Ability to sit for prolonged periods at inspection stations and manually handle, swirl, and manipulate small glass vials continuously.

Responsibilities

Perform comprehensive visual inspection of compounded sterile preparations using the designated inspection station and equipment.
Inspect vials against black and white backgrounds for designated intervals under specified light intensities.
Check container-closure integrity, including cracks, leaks, improper crimping or seals, and physical defects.
Rotate capped vials 360 degrees to verify that caps sit flat and are not angled.
Identify foreign matter, inappropriate particulate matter, discoloration, precipitation, cloudiness, and volume discrepancies.
Use 5–30 mL syringes to assess suspected low or high fill volumes.
Inspect lyophilized products for uniform appearance, porous cake structure, and absence of collapsed cakes.
Perform reconstitution visual inspections on designated sample sizes using appropriate diluents.
Evaluate reconstituted solutions for particulates, solubility, and clarity.
Report rejections to the Quality Manager for decisions about expanded sampling or further investigation.
Separate passing and rejected units into designated trays or totes to prevent cross-contamination or accidental release.
Document rejections in the batch folder.
Package rejected vials in labeled clear bags and submit them with the batch record for Quality Manager or Pharmacist-in-Charge review.
Report visual inspection failures to the Pharmacy Manager or QC Manager to initiate Quality Related Event records and root-cause investigations.
Follow proper destruction logging procedures for controlled substance rejections under SOP 1.046.
Take mandatory eye-rest breaks, such as a break every 30 minutes.
Follow safety, hygiene, PPE, spill cleanup, and laboratory safety procedures.
Maintain a clean, organized, compliant inspection workstation in the QA unit.