Quality Assurance Technician (Weekend/Day Shift)

Position Type: Full-Time
Shift: Friday, Saturday, and Sunday; 6am-6pm
Location: Gilbert, AZ
Pay Rate: $26.00 – $29.00 per hour 

The Quality Assurance Technician ensures site-specific compliance in accordance with Strive Pharmacy's Standard Operating Procedures (SOPs) and specifications. This role involves the quality review of documentation, label control, product inspections, and assisting with product release activities.

Key Responsibilities

• Product & Process Inspection: Perform product inspections for defects, leaks, and particulates. Assist in media fill process validations, including the inspection of filled units.
• Environmental Monitoring: Conduct environmental monitoring of personnel (as needed) and maintain accurate documentation.
• Documentation Review: Review compounding activities, including cleaning records, line clearance forms, inventory sheets, temperature logs, and Building Management System (BMS) alarms. Ensure all documentation is complete.
• Material & Label Control: Verify that raw materials meet specifications, account for labeling, and assist with raw material release and movement.
• Quality Events & Investigations: Document instances of non-compliance. Under the direction of a supervisor, initiate quality events for deviation and non-compliant investigations, including routing samples to the appropriate lab for particulate or microbial analysis.
• Records & Maintenance: Maintain organized quality records (e.g., equipment calibration, maintenance files, training logs, cleanroom certifications, and Certificates of Analysis).
• Audit & Team Support: Support internal and external audits and actively participate in Quality Manager staff meetings.

Required Qualifications

• Education: Minimum of a High School Diploma or GED with relevant work experience.
• Experience: Minimum of 2 years of experience in a quality or manufacturing department within a highly regulated industry (Pharmaceutical, Medical Device, or Allied Health Science preferred).
• SOP Proficiency: Proven experience reading, understanding, following, and reporting on Standard Operating Procedures.

Preferred Qualifications

• Education: Associate's degree or higher in a technical or scientific discipline (Biology, Microbiology, Chemistry, or Pharmacy).
• Technical Knowledge: Experience in aseptic operations and familiarity with Pharmaceutical Quality Assurance practices.
• Soft Skills: Strong organizational skills, sharp attention to detail, and the ability to effectively troubleshoot issues.

Work Environment

• This position is primarily based in an onsite work environment. The role requires regular periods of sitting, standing, and computer use, with occasional lifting as needed. Reasonable accommodations may be made for individuals with disabilities. 
• Comfortable working in a cleanroom environment, which includes wearing protective cleanroom attire, working in restricted or small areas, tolerating controlled temperatures, and enduring moderate to loud noise levels.
• Frequently required to sit, stand, walk, talk, listen, and use hands to handle or feel objects.
• Must be able to occasionally lift and/or move up to 45 pounds.