Visual Inspection Associate – Sterile Compounding

As a Visual Inspection Associate, you will be responsible for performing detailed visual inspections of sterile compounded pharmaceutical preparations to ensure products meet established quality standards, inspection criteria, and patient safety requirements. You will identify visible defects, maintain accurate inspection documentation, and support compliance with USP <797>, applicable state Board of Pharmacy regulations, and facility standard operating procedures.

Reporting to QA Compliance, you will work closely with pharmacy operations and quality teams to ensure consistent inspection practices, accurate documentation, and timely escalation of product quality concerns. This role offers the opportunity to contribute directly to patient safety while supporting an expanding sterile compounding operation and its readiness for ACHC/PCAB accreditation.

• Perform visual inspections of sterile compounded pharmaceutical preparations, including injectable medications packaged in vials, syringes, and other sterile containers, as applicable
• 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, established acceptance criteria, and standard operating procedures (SOPs) to ensure consistent inspection practices
• Utilize designated inspection stations, lighting, contrasting backgrounds, and other approved visual inspection equipment
• Identify and appropriately segregate products that fail established visual inspection acceptance criteria
• Promptly escalate suspected defects, inspection discrepancies, and product quality concerns to QA Compliance
• Maintain consistent inspection accuracy and attention to detail while performing repetitive inspection activities
• 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 established procedures for product handling, inspection, segregation, and escalation of nonconforming products
• Ensure inspection activities support product quality, patient safety, and established regulatory requirements
• Maintain clean, organized, and compliant visual inspection workstations
• Follow approved procedures for the proper handling and protection of sterile compounded 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 visual inspection accuracy, consistency, and compliance

• Accurately complete visual inspection records, including product identification, lot or batch information, inspection results, and identified defects
• Document inspection outcomes in accordance with established procedures and good documentation practices
• Maintain complete and traceable records of inspected, accepted, rejected, and segregated products
• Ensure inspection documentation is completed accurately and contemporaneously
• Record and escalate recurring defects, inspection discrepancies, or unusual product observations to QA Compliance
• Support the maintenance of inspection logs, equipment records, and qualification documentation
• Assist QA Compliance with inspection record retrieval and documentation reviews during audits or regulatory inspections

• High school diploma or equivalent required
• Previous experience in pharmaceutical manufacturing, sterile compounding, visual inspection, or a regulated production environment preferred
• Experience performing visual inspections of sterile pharmaceutical products, including injectable preparations, vials, or syringes, strongly preferred
• Familiarity with visible particulate inspection, pharmaceutical container defects, and established inspection acceptance criteria
• Understanding of USP <797>, pharmaceutical quality standards, or regulated pharmacy operations preferred
• Exceptional attention to detail and ability to identify subtle visual defects and product abnormalities
• Ability to consistently perform repetitive, detail-oriented inspection tasks 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

• 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

• Extended periods of sitting or standing while performing detailed visual inspection activities
• Ability to perform repetitive fine-motor tasks and handle pharmaceutical containers with precision
• Visual acuity, with or without corrective lenses, sufficient to meet established inspection qualification requirements
• Ability to maintain sustained visual concentration and attention to detail throughout inspection activities
• Ability to safely handle sterile pharmaceutical containers and operate designated inspection equipment
• Work in a controlled pharmaceutical environment requiring appropriate protective clothing and personal protective equipment (PPE)
• Ability to follow applicable hygiene, gowning, and safety requirements
• Ability to lift up to 35 lbs