Quality Technician - Visual Inspection Job at Eagle Pharma Outsourcing LLC in Bi

Role Summary  

A Quality - Visual Inspection Technician is a key member of the Quality Team and 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 additional pre-release inspections. While visual inspection is the main emphasis for this position, this position will also participate in other quality related tasks and duties.

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 Control Functions and Tasks

• Perform environmental and personnel monitoring associated with batch production
• Conduct routine environmental monitoring of controlled compounding areas
• Record room conditions in appropriate monitoring software
• Other routine quality control tasks as determined by the Quality Management

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.
• Physical Requirements: Ability to stand for extended periods, lift moderate weights, and work in a controlled environment; must have 20/20 vision either aided or unaided and complete inspection certification
• Must have the ability to complete a two-day off-site training program

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 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