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Ensure and assist with site-specific quality compliance according to Strive Pharmacy SOPs & specifications; quality review of documents, label control, assist with release activities and product inspections.
Job Responsibility:
Perform product inspection for defects, leaks, and particulates
Environmental monitoring of personnel and complete documentation
Assist in media fill process validations
Perform documentation review of compounding activities (cleaning records, line clearance forms, inventory sheets)
Verify raw materials meet specification
Account for labeling
Review temperature and BMS alarms
Ensure product test results meet specification limits
Check that all documentation is complete
Document non-compliance and initiate investigations
Help with equipment calibration program and maintenance records
Assist with raw material release and movement
Support internal & external audits
Maintain quality records
Participate in Quality Manager’s staff meetings
Requirements:
Minimum of High School Diploma/GED with work experience
Minimum of 2 years' experience in a quality or manufacturing department in a highly regulated industry (ideally Pharmaceutical, Medical Device, or Allied Health Science)
Must have experience with Standard Operating Procedures (read, understand, follow, report)
Nice to have:
Experienced in aseptic operations
Experience within a regulated environment
Knowledge & skills in Pharmaceutical Quality Assurance Practices
Associates Degree or higher in Biology, Microbiology, Chemistry, or Pharmacy
Strong organizational skills and attention to detail
Ability to effectively troubleshoot issues
Comfortable working in a cleanroom environment (limited space, protective attire, controlled temperatures, loud noise)
What we offer:
Employer paid healthcare coverage after 30 days
Choice of FSA/HSA
Voucher for new hire scrubs (if applicable)
Parental leave
401(k) plan with matching
Weekends and holidays off
Free compounded medications to employees and immediate family