Quality Assurance Analyst

2 weeks ago

Madison, Wisconsin, United States Mirus Bio, LLC Full time
Job Overview

Position Summary:
At Mirus Bio, LLC, we have been at the forefront of developing transfection reagents and innovative technologies for over 25 years. Our commitment to maintaining a startup culture allows us to remain agile and responsive to the evolving landscape of science and medicine. We foster an environment that values creativity, initiative, and collaboration, ensuring our team is motivated to support our clients in achieving exceptional scientific outcomes.

Mission Statement:
Empower Discovery. Enable Innovation. Improve Life.

Role Description:
We are currently seeking a dedicated Quality Assurance Specialist to oversee document management and quality assurance evaluations of our product offerings. This role is essential in upholding the high standards of quality and efficacy that Mirus Bio is known for. Responsibilities may vary based on project demands and business priorities.

Key Responsibilities:

  • Facilitate the revision of all version-controlled documents within the quality management system.
  • Conduct thorough quality assessments of labels and data from various departments to ensure completeness, accuracy, and compliance.
  • Review and authorize raw materials, intermediate products, and final products.
  • Develop and validate product-specific quality documentation, including Certificates of Analysis and Certificates of Origin.
  • Support supplier quality initiatives, including the qualification of new suppliers and re-evaluation of existing ones.
  • Maintain comprehensive training records for all personnel.
  • Assist in updating quality procedures and implementing process enhancements.
  • Support onsite audits conducted by clients or regulatory bodies.
  • Manage deviations, investigations, change controls, and CAPAs to ensure prompt resolution.
  • Assist in the evaluation of customer complaints and inquiries as necessary.
  • Act as a subject matter expert on the Qualio electronic quality management system.
  • Engage in quality-related tasks within Mirus inventory and temperature monitoring systems.
  • Provide backup support for various quality functions as required.
  • Adhere to GMP guidelines and ensure compliance with quality standards.
  • Collaborate effectively with other departments, including facilities, shipping, production, and R&D.
  • Foster positive relationships during internal and external interactions.
  • Represent Mirus Bio in a professional and positive manner.
  • Exhibit behaviors aligned with the Mirus Bio Employee Handbook.
  • Perform additional duties as assigned by the Senior Quality Manager.

Qualifications:

Education:
Bachelor of Science (B.S.) degree or higher in Biology or a related field, with a minimum of 2 years of relevant experience in a cGMP environment. A preference for candidates with at least 5 years of experience.

Professional Skills:

  • Proven experience in quality document evaluation.
  • Ability to work effectively within a team setting.
  • Strong organizational skills with a focus on detail and record-keeping.
  • Excellent verbal and written communication abilities.
  • Proficiency in Microsoft Office Suite, including Excel, Word, and PowerPoint.
  • Experience in maintaining and qualifying suppliers.
  • Familiarity with quality auditing processes.
  • Prior experience in a life sciences organization is preferred.
  • Knowledge of cell biology techniques, including mammalian tissue culture and transfection.

Compensation:
This position offers a competitive salary range of $60,000 to $75,000, commensurate with experience.

Core Values:
Mirus Bio is dedicated to the following core values:

  • Empowerment
  • Passion
  • Integrity
  • Compassion
  • Collaboration
  • Innovation

We are committed to providing our customers and the scientific community with the highest quality transfection products, methods, and applications.

Diversity and Inclusion:
Mirus Bio is an equal opportunity employer, committed to fostering a diverse and inclusive workplace. We prohibit discrimination and harassment based on any protected characteristic as outlined by applicable laws.

Accommodation Statement:
Mirus Bio is dedicated to ensuring that all qualified individuals have equal access to employment opportunities. If you require reasonable accommodations during the application or interview process, please reach out to us.

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