About The Position

The Visual Inspection Associate performs detailed visual inspections of sterile compounded pharmaceutical preparations to ensure products meet established quality standards, inspection criteria, and patient safety requirements. The role identifies visible defects, maintains accurate inspection documentation, and supports compliance with USP <797>, applicable state Board of Pharmacy regulations, and facility standard operating procedures. Reporting to QA Compliance, the associate works closely with pharmacy operations and quality teams to promote consistent inspection practices, accurate documentation, and timely escalation of product quality concerns. This onsite role in Missouri City, Texas supports patient safety and an expanding sterile compounding operation, including readiness for ACHC/PCAB accreditation. The associate inspects sterile preparations such as injectable medications packaged in vials, syringes, and other sterile containers; checks for visible product and container defects; follows approved inspection procedures and acceptance criteria; and segregates and escalates products that do not meet requirements. The role also involves maintaining traceable inspection records, keeping workstations compliant, completing required training and competency assessments, and supporting audits, regulatory inspections, and continuous improvement initiatives. The role requires a high school diploma or equivalent. Experience in pharmaceutical manufacturing, sterile compounding, visual inspection, or regulated production is preferred, with direct inspection experience of sterile injectable preparations strongly preferred. The position includes extended periods of sitting or standing, repetitive fine-motor inspection tasks, sustained visual concentration, work in a controlled pharmaceutical environment with appropriate protective clothing and PPE, and lifting up to 35 pounds.

Requirements

  • High school diploma or equivalent required.
  • Exceptional attention to detail and ability to identify subtle visual defects and product abnormalities.
  • Ability to perform repetitive, detail-oriented inspection tasks consistently while maintaining accuracy and focus.
  • Strong organizational skills and ability to maintain accurate inspection records and documentation.
  • Ability to follow detailed written procedures, inspection criteria, and SOPs without deviation.
  • Strong communication skills and ability to promptly escalate product quality concerns.
  • Ability to work independently while collaborating with QA Compliance and pharmacy operations.
  • Ability to successfully complete required visual inspection training and qualification assessments.
  • Ability to meet established visual inspection qualification requirements, with or without corrective lenses.
  • Ability to safely handle sterile pharmaceutical containers and operate designated inspection equipment.
  • Ability to follow applicable hygiene, gowning, and safety requirements.
  • Ability to lift up to 35 lbs.

Nice To Haves

  • Previous experience in pharmaceutical manufacturing, sterile compounding, visual inspection, or a regulated production environment.
  • Experience performing visual inspections of sterile pharmaceutical products, including injectable preparations, vials, or syringes.
  • Familiarity with visible particulate inspection, pharmaceutical container defects, and established inspection acceptance criteria.
  • Understanding of USP <797>, pharmaceutical quality standards, or regulated pharmacy operations.
  • Experience performing manual visual inspection of sterile injectable pharmaceutical products.
  • Experience in a 503A compounding pharmacy, FDA-registered 503B outsourcing facility, or sterile pharmaceutical manufacturing environment.
  • Familiarity with USP <797> requirements and sterile compounding quality standards.
  • Experience using visual inspection booths, specialized lighting, contrasting backgrounds, or semi-automated inspection equipment.
  • Knowledge of visible particulate identification, container closure defects, and inspection acceptance criteria.
  • Experience documenting inspection results, defect classifications, and rejected product dispositions.
  • Familiarity with ACHC/PCAB accreditation standards and pharmacy quality documentation requirements.
  • Knowledge of good documentation practices (GDP) and applicable cGMP principles.
  • Previous experience working closely with Quality Assurance or QA Compliance teams.

Responsibilities

  • Perform visual inspections of sterile compounded pharmaceutical preparations, including injectable medications packaged in vials, syringes, and other sterile containers.
  • Inspect products for visible particulate matter, discoloration, cloudiness, clarity issues, and other observable product defects.
  • Examine containers for visible cracks, leaks, damaged closures, compromised seals, and other observable container integrity concerns.
  • Follow approved inspection procedures, acceptance criteria, and SOPs, using designated inspection stations, lighting, contrasting backgrounds, and other approved equipment.
  • Identify and segregate products that fail visual inspection acceptance criteria and promptly escalate suspected defects, discrepancies, and product quality concerns to QA Compliance.
  • Complete required visual inspection training, qualification assessments, and periodic competency evaluations.
  • Perform inspection activities in accordance with USP <797>, applicable state Board of Pharmacy regulations, and facility SOPs.
  • Follow procedures for product handling, inspection, segregation, and escalation of nonconforming products; maintain clean, organized, compliant workstations and protect sterile preparations.
  • Report observed defects, discrepancies, equipment concerns, and deviations promptly to QA Compliance.
  • Support internal audits, regulatory inspections, and ACHC/PCAB accreditation readiness through accurate inspection practices and documentation.
  • Participate in ongoing training and continuous improvement initiatives related to inspection accuracy, consistency, and compliance.
  • Accurately complete inspection records, including product identification, lot or batch information, inspection results, and identified defects.
  • Maintain complete, contemporaneous, and traceable records for inspected, accepted, rejected, and segregated products.
  • Record and escalate recurring defects, inspection discrepancies, or unusual product observations to QA Compliance.
  • Support inspection logs, equipment records, and qualification documentation, and assist with record retrieval and documentation reviews during audits or regulatory inspections.

Benefits

  • Medical plan options
  • Dental plan options
  • Vision plan options
  • Vacation time off policy, with up to 10 vacation days accrued in the first year; accrual begins immediately
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