Quality Assurance Technician (Weekend, Overnight)
About The Position
The Quality Assurance Technician ensures site-specific compliance with Strive Pharmacy’s Standard Operating Procedures (SOPs) and specifications. The role reviews quality documentation, controls labels, inspects products, and assists with product release activities. The position is based onsite in Gilbert, Arizona, and is scheduled Friday through Sunday from 6:00 PM to 6:00 AM. The technician performs product and process inspections, conducts environmental monitoring as needed, reviews compounding and facility documentation, verifies raw materials and labels, documents quality issues, and maintains quality records. Under a supervisor’s direction, the technician initiates quality events and supports investigations, including routing samples for particulate or microbial analysis. The role also supports internal and external audits and participates in Quality Manager staff meetings. The work takes place in a cleanroom environment and involves protective attire, restricted or small areas, controlled temperatures, and moderate to loud noise. The position requires regular sitting, standing, and computer use, as well as walking, handling objects, and occasional lifting or moving of up to 45 pounds. Reasonable accommodations may be made for individuals with disabilities.
Requirements
- High school diploma or GED with relevant work experience.
- At least 2 years of experience in a quality or manufacturing department within a highly regulated industry.
- Proven experience reading, understanding, following, and reporting on Standard Operating Procedures (SOPs).
- Ability to work in a cleanroom environment, including wearing protective cleanroom attire and working in restricted or small areas.
- Ability to occasionally lift and/or move up to 45 pounds.
Nice To Haves
- Experience in a pharmaceutical, medical device, or allied health science industry.
- Associate’s degree or higher in a technical or scientific discipline such as Biology, Microbiology, Chemistry, or Pharmacy.
- Experience in aseptic operations.
- Familiarity with Pharmaceutical Quality Assurance practices.
- Strong organizational skills, sharp attention to detail, and the ability to effectively troubleshoot issues.
Responsibilities
- Inspect products for defects, leaks, and particulates.
- Assist with media fill process validations, including inspecting filled units.
- Conduct environmental monitoring of personnel as needed and maintain accurate documentation.
- Review compounding activities and records, including cleaning records, line clearance forms, inventory sheets, temperature logs, and Building Management System (BMS) alarms; ensure documentation is complete.
- Verify that raw materials meet specifications, account for labeling, and assist with raw material release and movement.
- Document instances of non-compliance.
- Under a supervisor’s direction, initiate quality events for deviation and non-compliant investigations, including routing samples to the appropriate lab for particulate or microbial analysis.
- Maintain organized quality records, including equipment calibration and maintenance files, training logs, cleanroom certifications, and Certificates of Analysis.
- Support internal and external audits.
- Participate in Quality Manager staff meetings.
Benefits
- Employer-paid healthcare coverage, effective the first day of the month following the hire date.
- Free Strive compounded medications for employees based on a valid patient-specific prescription from a licensed healthcare provider.
- Paid time off.
- Sick time.
- FSA and HSA options.
- Parental leave.
- 401(k) with employer matching.
- Life insurance.
- Vision and dental insurance.
- Veterinary insurance.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
