Temporary Quality Assurance Specialist

At the Vitrolife Group, we work every day to unlock the full potential of science and technology to reduce the barriers towards building a family. Together we help our customers and their patients to fulfill the dream of having a baby.

Location: Denver, CO

Duration: Temporary Assignment

Salary Range: $35 - $45/hr

Position Summary

The Temporary Quality Assurance Specialist provides quality oversight and support for quality systems, validation activities, aseptic processing programs, and regulatory compliance initiatives. This role is responsible for authoring, reviewing, and approving validation documentation, supporting continuous improvement of the Quality Management System (QMS), and ensuring that all quality processes align with applicable regulatory requirements and industry standards.

Key Responsibilities

• Author, review, and approve validation protocols, reports, and supporting documentation for:
• Aseptic process simulations (media fills)
• Sterilization
• Equipment and process validation
• Utilities, environmental monitoring, and 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 compliance
• Support internal and external audits, inspections, and quality assessments
• Assist in the development, revision, and implementation of quality procedures and standards
• Collaborate cross-functionally to identify and implement quality and process improvements Qualifications

• Bachelor’s degree in Microbiology, Biology, Engineering, Pharmaceutical Sciences, or a related scientific discipline
• Minimum of 5 years of experience in Quality Assurance, Validation, or Quality Systems within a GMP-regulated pharmaceutical, biotechnology, 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
• Experience authoring and reviewing validation protocols, reports, investigations, risk assessments, and technical documentation
• Working knowledge of current GMP regulations and quality system requirements
• Strong technical writing, organizational, and analytical skills
• Ability to manage multiple priorities and meet deadlines

Preferred Qualifications

• Direct experience supporting sterile drug or medical device manufacturing and aseptic filling operations
• Knowledge of ISO 13408 and/or EU GMP Annex 1
• Experience reviewing and approving:
• Media fill protocols and reports
• Contamination control strategies
• Environmental monitoring programs
• Sterilization validations
• Experience supporting regulatory inspections and audit readiness activities
• Familiarity with risk management methodologies and quality system effectiveness monitoring

Additional Information

• This is a temporary position with immediate need
• Competitive compensation based on experience
  
  

An offer of employment is contingent on the successful passing of a background check. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire

Vitrolife Group is a global provider of medical devices and genetic services. Based on science and advanced research capabilities, we develop services and products for personalized genetic information and medical device products. We support our customers by improving their clinical practice for the patient's outcome of fertility treatment.

We are currently approximately 1 100 colleagues worldwide, with headquarters in Gothenburg, Sweden. Vitrolife Group's products and services are available in more than 110 countries through our own presence in 30 countries and a network of distributors. Vitrolife Group is a sustainable market leader and aims to be the preferred partner for IVF-clinics by providing superior products and services with the vision of fulfilling the dream of having a baby. The Vitrolife share is listed on Nasdaq Stockholm.