Aseptic Quality Assurance Technician - Pharma

Strive Compounding Pharmacy; Fenton (MO); On-site; USD 33,000 - 39,000; Full time

Benefits offered by this job

Healthcare coverage

Paid time off

Sick time

HSA/FSA options

Parental leave

401(k) with employer matching

Life insurance

Vision and dental

Pet/vet insurance

Job summary

Strive Pharmacy is a personalized compounding pharmacy seeking a Quality Assurance professional to ensure site-specific quality compliance and support sterile production areas. This full-time onsite role involves document reviews, SOP adherence, and participation in audits to uphold high standards of patient safety.

Key duties include environmental monitoring, equipment calibration support, and maintaining comprehensive quality records.

Qualifications

• Minimum of High School Diploma/GED with work experience.
• Minimum of 2 years experience in a quality or manufacturing department of a pharmaceutical, Medical Device or Allied Health Science.
• Experienced in aseptic operations.
• Experience within a regulated environment.
• Associates Degree or higher level degree in Technician technical scientific discipline, Biology, Microbiology, Chemistry or Pharmacy.

Responsibilities

• Perform product inspection for defects, leaks and particulates.
• Environmental monitoring of sterile production areas and complete documentation.
• Aseptically handle media plates and broth.
• Assist in media fill process validations to include inspection of filled units.
• Document and review compounding activities such as cleaning records, line clearance forms and inventory sheets.
• Assist with equipment calibration program and maintenance record files.
• Assist with raw material release and movement.
• Document and initiate quality events for deviation and noncompliant investigations under supervision.
• Support internal & external audits.
• Maintain quality records (calibration, maintenance, training, deviation and compliant investigation, environmental monitoring, COA, clean room certification).
• Participate in Quality Manager’s staff meetings.

Skills

Pharmacy operations knowledge

Regulatory guidelines

Calculations

Attention to detail

Troubleshooting

Procedural compliance

Education

High School Diploma or GED

2+ years in pharma quality/manufacturing

Aseptic operations experience

Regulated environment experience

Technical/science degree (Assoc or higher)

Job description

Strive Pharmacy is a personalized compounding pharmacy seeking a Quality Assurance professional to ensure site-specific quality compliance and support sterile production areas. This full-time onsite role involves document reviews, SOP adherence, and participation in audits to uphold high standards of patient safety.

Key duties include environmental monitoring, equipment calibration support, and maintaining comprehensive quality records.