Talent.com
Quality Control Microbiology

Quality Control Microbiology

VPI CompoundingEnglewood, CO, US
4 days ago
Job type
  • Full-time
Job description

Job Description

Job Description

Salary : $26- $30 per hour. DOE

Quality Control Microbiology

Department : Quality

Location : Centennial, CO, 80112

Employment Type : Full-Time.

Compensation : $26-30 per hour

Job Summary

The Microbiologist will be responsible for overseeing environmental monitoring, sterility testing, and microbial identification processes to ensure compliance with USP

, and

, as well as FDA and state board regulations. This role plays a critical part in maintaining aseptic conditions and ensuring the microbiological integrity of compounded sterile preparations.

Key Responsibilities

Environmental Monitoring :

  • Perform routine and non-routine and non-viable EM of ISO-classified cleanrooms
  • Conduct active air, passive air, surface, and personal sampling during and after operations
  • Analyze data trends and ensure results are within facility-specific alert and action levels
  • Ensure proper sampling coverage of critical and non-critical zones.

Microbiological Testing of Utilities and Materials :

  • Test purified water systems, surfaces, and personnel for microbial contamination
  • Conduct bioburden testing of raw materials and components prior to compounding
  • Maintain sample traceability and data integrity from collection through result reporting
  • Sterility Assurance and USP

    Testing :

  • Coordinate sterility testing for CSPs using membrane filtration or direct inoculation
  • Monitor incubation and growth observations according to USP
  • Document results and escalate any abnormal findings per established protocols
  • Endotoxin Testing (USP

    ) :

  • Oversee bacterial endotoxin testing (BET) using LAL methods (gel-clot, chromogenic, turbidimetric)
  • Ensure test methods meet compendial and product-specific requirements
  • Investigate test failures and assess impact on product quality and safety.
  • Microbial Identification and Trending :

  • Identify recovered organisms using Gram staining and advanced ID tools
  • Track trends in cleanroom isolates and product contamination data
  • Prepare monthly and quarterly microbiological trending reports (Data gave me this frequency - can change to reflect our needs - or leave as is)
  • OOS and Excursion Investigations :

  • Lead microbiology-related investigations for out-of-specification results or EM excursions
  • Perform root cause analysis and implement CAPs in collaboration with QA
  • Ensure accurate, complete, and timely investigation documentation
  • Aseptic Technique and Gowning Qualification Support :

  • Observe and evaluate aseptic practices during media fills and daily operations
  • Assist with training, qualification, and periodic requalification of cleanroom personnel
  • Review gowning footage and aseptic practices for compliance with SOPs
  • Laboratory Equipment Maintenance and Qualification :

  • Oversee calibration and maintenance of EM and microbiology lab equipment (e.g., air sampler, endotoxin readers)
  • Maintain equipment logs, service records, and calibration certificates
  • Ensure compliance with cGMPs and lab SOPs
  • SOP Management and Document Control :

  • Draft, revise, and review SOPs, protocols, and microbiological test methods
  • Ensure alignment with USP chapters, FDA guidance, and internal procedures
  • Support regular SOP review cycles and change control processes
  • Interdepartmental Collaboration :

  • Partner with QA and Production on cleanroom control and contamination risk management
  • Participate in cross-functional meetings, audits, and projects
  • Provide microbiological input for risk assessments and change controls
  • Audit and Regulatory Support :

  • Prepare and present microbiology data during internal and external audits
  • Support regulatory inspections with required documentation
  • Maintain an audit-ready state through continuous compliance
  • Physical Demands :

  • Ability to stand for long periods of time during cleanroom monitoring or gowning activities
  • Fine motor skills to handle small lab tools, pipettes, swabs, and other microbiological equipment
  • Ability to lift and carry equipment or testing materials weighing up to 25 pounds
  • Good visual acuity (with or without corrective lenses) for microscopic analysis and detailed data review
  • Capability to work in controlled environments (temperature and humidity controlled cleanrooms)
  • Occasional sitting, bending, crouching, or reaching as required by cleanroom tasks
  • Required Qualifications :

  • Bachelors Degree in Microbiology, Biology, or related field
  • Minimum 2 years of experience in microbiological testing in a regulated pharmaceutical, biotech, or compounding environment
  • Working knowledge of USP chapters :
  • Familiarity with aseptic technique and cleanroom practices in GMP / GLP settings
  • Experience with environmental monitoring, bioburden testing, and sterility testing protocols
  • Strong understanding of cGMPs, FDA guidelines, and quality documentation practices
  • Proficiency in Google Suit and LIMS or quality documentation systems
  • Benefits

  • Company-paid health, dental, and vision insurance.
  • 401(k) plan with employer match.
  • Paid Holidays, Floating Holidays, and Paid Time Off (PTO).
  • Tuition and Certification Reimbursement Programs.
  • RTD EcoPass for public transportation.
  • Opportunities for professional growth and development.
  • Equal Opportunity Employer

    VPI Compounding Pharmacy is an Equal Employment Opportunity (EEO) employer. We are committed to providing equal opportunity for all qualified individuals employed by or seeking employment with VPI, regardless of race, color, creed, religion, sex, sexual preference, national origin, age, marital status, veteran status, or non-job-related disabilities. This policy extends to all areas of employment, including recruitment, job assignment, promotion, and other terms of employment.

    Create a job alert for this search

    Quality Control • Englewood, CO, US

    Related jobs
    • Promoted
    Microbiology Technician

    Microbiology Technician

    ProbiLafayette, CO, US
    Full-time
    Probi USA is a dynamic and rapidly expanding manufacturing company based in Lafayette, CO.With a reputation for excellence in producing probiotics and nutritional supplements, Probi USA serves as a...Show moreLast updated: 4 days ago
    • Promoted
    Travel Invasive Cardiovascular Technologist (Cardiac Cath Lab)

    Travel Invasive Cardiovascular Technologist (Cardiac Cath Lab)

    Springboard HealthcareBrighton, CO, US
    Full-time
    Springboard Healthcare is seeking a travel Cath Lab Technologist for a travel job in Brighton, Colorado.Job Description & Requirements. Springboard Healthcare Job ID #787543.Pay package is based...Show moreLast updated: 12 days ago
    • Promoted
    Travel Cath Lab Technologist

    Travel Cath Lab Technologist

    Trustaff AlliedBrighton, CO, US
    Full-time
    Trustaff Allied is seeking a travel Cath Lab Technologist for a travel job in Brighton, Colorado.Job Description & Requirements. As a Cath Lab Tech, you'll be the primary resource for techni...Show moreLast updated: 30+ days ago
    • Promoted
    Quality Control Tech

    Quality Control Tech

    Foley Products CompanyLittleton, CO, US
    Full-time
    The QC Tech continuously monitors products and materials for compliance to ACPA, NPCA, and multiple DOTs standards.Essential Job Functions / Duties : .Successfully plan a...Show moreLast updated: 10 days ago
    • Promoted
    Travel Cath Lab Technologist

    Travel Cath Lab Technologist

    MedPro Healthcare Allied StaffingCastle Rock, CO, US
    Full-time
    MedPro Healthcare Allied Staffing is seeking a travel Cath Lab Technologist for a travel job in Castle Rock, Colorado.Job Description & Requirements. Joint Commission-certified staffing agency, ...Show moreLast updated: 30+ days ago
    • Promoted
    Quality Control Technician (2nd Shift)

    Quality Control Technician (2nd Shift)

    Leiters IncEnglewood, CO, US
    Full-time
    Quality Control Technician (1st Shift).This position reports to the Quality Control Supervisor.The role is responsible for performing quality activities and maintaining a quality laboratory environ...Show moreLast updated: 10 days ago
    • Promoted
    Travel Cath Lab Technologist

    Travel Cath Lab Technologist

    ADEX Healthcare Staffing LLCCastle Rock, CO, US
    Full-time
    ADEX Healthcare Staffing LLC is seeking a travel Cath Lab Technologist for a travel job in Castle Rock, Colorado.Job Description & Requirements. Pay package is based on 10 hour shifts and 40 hou...Show moreLast updated: 30+ days ago
    • Promoted
    Clinical Lab Tech - Microbiology

    Clinical Lab Tech - Microbiology

    UCHealthAurora, CO, United States
    Full-time
    UCHealth Leprino Building AMC, US : CO : Aurora.Full-time position, working 70 hours per pay period (0.Day shift, from 3 : 00 AM to 1 : 30 PM. Pay is dependent on applicant's relevant experience.Performs la...Show moreLast updated: 30+ days ago
    • Promoted
    Travel Cath Lab Technologist

    Travel Cath Lab Technologist

    Host HealthcareCastle Rock, CO, US
    Full-time
    Host Healthcare is seeking a travel Cath Lab Technologist for a travel job in Castle Rock, Colorado.Job Description & Requirements. Pay package is based on 10 hour shifts and 40 hours per week (...Show moreLast updated: 30+ days ago
    • Promoted
    Travel Invasive Cardiovascular Technologist (Cardiac Cath Lab)

    Travel Invasive Cardiovascular Technologist (Cardiac Cath Lab)

    Medical SolutionsBrighton, CO, US
    Full-time
    Medical Solutions is seeking a travel Cath Lab Technologist for a travel job in Brighton, Colorado.Job Description & Requirements. We’re seeking talented healthcare professionals whose adv...Show moreLast updated: 30+ days ago
    • Promoted
    Travel Cath Lab Technologist

    Travel Cath Lab Technologist

    Springboard HealthcareCastle Rock, CO, US
    Full-time
    Springboard Healthcare is seeking a travel Cath Lab Technologist for a travel job in Castle Rock, Colorado.Job Description & Requirements. Springboard Healthcare Job ID #782393.Pay package is ba...Show moreLast updated: 30+ days ago
    • Promoted
    Travel Invasive Cardiovascular Technologist (Cardiac Cath Lab)

    Travel Invasive Cardiovascular Technologist (Cardiac Cath Lab)

    Host HealthcareBrighton, CO, US
    Full-time
    Host Healthcare is seeking a travel Cath Lab Technologist for a travel job in Brighton, Colorado.Job Description & Requirements. Pay package is based on 8 hour shifts and 40 hours per week (subj...Show moreLast updated: 30+ days ago
    • Promoted
    Travel Invasive Cardiovascular Technologist (Cardiac Cath Lab)

    Travel Invasive Cardiovascular Technologist (Cardiac Cath Lab)

    Uniti MedBrighton, CO, US
    Full-time
    Uniti Med is seeking a travel Cath Lab Technologist for a travel job in Brighton, Colorado.Job Description & Requirements. Cigna medical, MetLife dental and vision insurance .License reimbu...Show moreLast updated: 4 days ago
    • Promoted
    Travel Cath Lab Technologist

    Travel Cath Lab Technologist

    Triage StaffingBrighton, CO, US
    Full-time
    Triage Staffing is seeking a travel Cath Lab Technologist for a travel job in Brighton, Colorado.Job Description & Requirements. Travel Radiology : Cath Lab Tech Brighton.Location : &nb...Show moreLast updated: 30+ days ago
    • Promoted
    Travel Invasive Cardiovascular Technologist (Cardiac Cath Lab)

    Travel Invasive Cardiovascular Technologist (Cardiac Cath Lab)

    SpireBrighton, CO, US
    Full-time
    Spire is seeking a travel Cath Lab Technologist for a travel job in Brighton, Colorado.Job Description & Requirements.Spire lives by the motto "Prescription before Diagnosis, equals malpra...Show moreLast updated: 30+ days ago
    • Promoted
    Local Contract Invasive Cardiovascular Technologist (Cardiac Cath Lab)

    Local Contract Invasive Cardiovascular Technologist (Cardiac Cath Lab)

    Host HealthcareBrighton, CO, US
    Full-time
    Host Healthcare is seeking a local contract Cath Lab Technologist for a local contract job in Brighton, Colorado.Job Description & Requirements. Pay package is based on 8 hour shifts and 40 hour...Show moreLast updated: 30+ days ago
    • Promoted
    Travel Cath Lab Technologist

    Travel Cath Lab Technologist

    Fusion Medical Staffing-Cath LabCastle Rock, CO, US
    Full-time
    Fusion Medical Staffing-Cath Lab is seeking a travel Cath Lab Technologist for a travel job in Castle Rock, Colorado.Job Description & Requirements. Facility in Castle Rock, Colorado.Fusion Medi...Show moreLast updated: 30+ days ago
    • Promoted
    Travel Cath Lab Technologist

    Travel Cath Lab Technologist

    Travel Nurses, Inc.Castle Rock, CO, US
    Full-time
    Cath Lab Technologist for a travel job in Castle Rock, Colorado.Job Description & Requirements.Pay package is based on 8 hour shifts and 40 hours per week (subject to confirmation) with tax-fre...Show moreLast updated: 30+ days ago