About this role
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.