Quality Assurance Specialist (Contract)

Location: Denver Metro Area (Hybrid – On-site 2–3 Days per Week)
Duration: 6–9 Month Temporary Assignment
Pay Rate: $36–$45/hour

Position Summary

We are seeking an experienced Quality Assurance Specialist for a 6–9 month contract assignment supporting quality and compliance activities within a GMP-regulated manufacturing environment. This hybrid position will provide quality oversight for validation programs, aseptic processing operations, quality systems, and regulatory compliance initiatives.

The successful candidate will possess strong experience in aseptic manufacturing, contamination control, validation documentation, and Quality Management Systems (QMS), with the ability to work cross-functionally to maintain compliance and drive continuous improvement.

Key Responsibilities

• Author, review, and approve validation protocols, reports, and supporting documentation related to:
  

  • Aseptic process simulations (media fills)
    

  • Sterilization validation
    

  • Equipment qualification
    

  • Process validation
    

  • Utilities validation
    

  • Environmental monitoring programs
    

  • Cleanroom operations
    

  
  

• Provide QA oversight of aseptic processing activities to ensure compliance with regulatory requirements and internal procedures.
  

• Participate in quality system activities, including deviations, investigations, CAPAs, change controls, and risk assessments.
  

• Review quality records and documentation for completeness, accuracy, and GMP compliance.
  

• Support internal audits, external audits, inspections, and quality assessments.
  

• Assist in the development, revision, and implementation of quality procedures, policies, and standards.
  

• Collaborate with cross-functional teams to identify opportunities for quality and process improvements.
  

• Support regulatory compliance and audit readiness initiatives.

Required Qualifications

• Bachelor’s degree in Microbiology, Biology, Engineering, Pharmaceutical Sciences, or a related scientific discipline.
  

• Minimum of 5 years of Quality Assurance, Validation, or Quality Systems experience within a GMP-regulated pharmaceutical, biotechnology, medical device, or sterile manufacturing environment.
  

• Demonstrated experience supporting aseptic manufacturing operations and contamination control programs.
  

• Strong knowledge of:
  

  • Aseptic process simulations (media fills)
    

  • Environmental monitoring
    

  • Sterilization validation
    

  • Cleanroom operations
    

  • Validation lifecycle activities
    

  
  

• Experience authoring and reviewing validation protocols, reports, investigations, risk assessments, and technical quality documentation.
  

• Working knowledge of current GMP regulations and quality system requirements.
  

• Strong technical writing, organizational, analytical, and problem-solving skills.
  

• Ability to manage multiple projects and priorities in a fast-paced environment.

Preferred Qualifications

• Direct experience supporting sterile drug product manufacturing, aseptic filling operations, or sterile medical device manufacturing.
  

• Knowledge of ISO 13408 and/or EU GMP Annex 1 requirements.
  

• Experience reviewing and approving:
  

  • Media fill protocols and reports
    

  • Contamination control strategies
    

  • Environmental monitoring programs
    

  • Sterilization validation documentation
    

  
  

• Experience supporting regulatory inspections and audit readiness activities.
  

• Familiarity with risk management methodologies and quality system effectiveness monitoring.

Additional Information

• Hybrid position located in the Denver metro area with an on-site presence required 2–3 days per week.
  

  • Candidates must currently reside in the greater Denver, Colorado area.
    

  
  

• This is a temporary assignment anticipated to last 6–9 months.
  

  • Candidates must be authorized to work in the United States and eligible for W2 employment through Kelly Science.
    

  
  

• Pay rate is $36–$45/hour, based on experience and qualifications.
  

• This role offers the opportunity to support critical quality, validation, and compliance initiatives within a GMP-regulated manufacturing environment.

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