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Strive Compounding Pharmacy · 1 hour ago

Quality Assurance Technician

Leesburg, VA

Full-time

Onsite

Entry Level

2+ years exp

Strive Pharmacy is dedicated to disrupting the pharmaceutical industry by providing personalized solutions through compounding. The Quality Assurance Technician will ensure quality compliance, perform product inspections, and assist with documentation and audits to maintain high standards in pharmaceutical practices.

Health CareMedicalPharmaceutical

Responsibilities

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

Qualification

Aseptic operationsPharmaceutical Quality AssuranceRegulated environment experienceBiology knowledgeMicrobiology knowledgeChemistry knowledgeTroubleshooting abilityCleanroom environment comfortOrganizational skillsAttention to detail

Required

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

Preferred

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