Quality Assurance Technician
About The Position
The Quality Assurance Technician ensures and assists with site-specific quality compliance in accordance with Strive Pharmacy SOPs and specifications. The role supports quality review of documents, label control, product release activities, and product inspections. It also helps maintain quality records and supports audits, investigations, equipment calibration, and raw material release. This is a full-time, on-site position. The schedule is Monday through Friday, 8:00 a.m. to 4:30 p.m. during four weeks of training, then Monday through Friday, 7:00 a.m. to 3:30 p.m. The role is primarily onsite and involves periods of sitting, standing, and computer use, with occasional lifting. The cleanroom environment may involve limited space, protective attire, controlled temperatures, and loud noise. The hourly pay rate is $24–$28.
Requirements
- High school diploma or GED, with work experience.
- At least 2 years of experience in a quality or manufacturing department of a pharmaceutical, medical device, or allied health science organization.
Nice To Haves
- Experience in aseptic operations.
- Experience in a regulated environment.
- Knowledge and skills in pharmaceutical quality assurance practices.
- Associate degree or higher in a technical or scientific discipline such as biology, microbiology, chemistry, or pharmacy.
- Strong organizational skills and attention to detail.
- Ability to troubleshoot issues effectively.
- Comfort working in a cleanroom environment that may be limited to a small area, require protective cleanroom attire, and involve controlled temperatures and loud noise.
Responsibilities
- Inspect products for defects, leaks, and particulates.
- Monitor personnel in the environment as needed and complete related documentation.
- Assist with media fill process validations, including inspection of filled units.
- Review compounding documentation, including cleaning records, line clearance forms, and inventory sheets.
- Verify that raw materials meet specifications.
- Account for labeling.
- Review temperature and BMS alarms.
- Ensure product test results meet specification limits.
- Check that documentation is complete.
- Document non-compliance and work with a supervisor or lead if further investigation is needed, including referral to an appropriate lab for particulate identification or microbial analysis.
- Help with the equipment calibration program and maintenance record files.
- Assist with raw material release and movement.
- Under supervisor or lead direction, document and initiate quality events for deviation and noncompliant investigations.
- Support internal and external audits.
- Maintain quality records, including equipment calibration and maintenance, training, deviation and compliant investigations, environmental monitoring, certificates of analysis, and cleanroom certification.
- Participate in the Quality Manager’s 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
Mid Level
Education Level
High school or GED
