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.
Perform product inspection for defects, leaks, and particulates
Environmental monitoring of personnel (as needed) and complete documentation
Assist in the media fill process validations to include inspection of filled units
Perform documentation review of compounding activities such as cleaning records, line clearance forms, and inventory sheets:
Verify that raw materials meet specification
Account for labeling
Review temperature and BMS alarms
Ensure that product test results meet specification limits
Checking that all documentation is complete
Document non-compliance and work with supervisor/lead if further investigation is needed appropriate lab for particulate identification or microbial analysis
Help with equipment calibration program and maintenance record files
Assist with raw material release and movement
Under the direction of supervisor/lead, document and initiate quality events for deviation and noncompliant investigations
Support internal & external audits
Maintain quality records (equipment calibration and maintenance, training, deviation and compliant investigation, environmental monitoring, certificate of analysis, clean room certification etc.)
Participate in Quality Manager’s staff meetings
Minimum of High School Diploma/GED with work experience
Minimum of 2 years experience in a quality or manufacturing department of in a highly regulated industry. Ideally Pharmaceutical, Medical Device, or Allied Health Science.
Must have experience with Standard Operating Procedures. Read, understand, follow, report.
Experienced in aseptic operations
Experience within a regulated environment
Knowledge & skills in Pharmaceutical Quality Assurance Practices
Associates Degree or higher level degree in technician technical scientific discipline; Biology, Microbiology, Chemistry, or Pharmacy
Strong organizational skills and attention to detail
Ability to effectively troubleshoot issues
Comfortable working in a cleanroom-working environment that may be limited to a small area, wearing protective cleanroom attire, tolerating controlled temperatures, and loud noise
Strive Pharmacy provides a comprehensive benefits package that encompasses various perks such as employer paid healthcare coverage available after 30 days of employment, the choice of an FSA/HSA, a voucher for new hire scrubs (if applicable), parental leave, a 401(k) plan with matching contributions, and the benefit of weekends and holidays off.
FREE COMPOUNDED MEDS to employees and immediate family members.