Quality Assurance Specialist

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 proprietary technologies for over 25 years. Our commitment to innovation and agility allows us to adapt to the latest trends in the scientific community. We are dedicated to fostering a culture that values creativity, initiative, and respect among our team members, who are driven by the goal of supporting our clients in achieving exceptional scientific outcomes.

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

Role Description:
We are seeking a meticulous Quality Assurance Technician to join our Quality Team. This role is essential in supporting quality assurance, document management, and quality oversight activities. Reporting to the Senior Quality Manager, the technician will collaborate closely with various departments including Quality, Operations, Production, and Shipping. A keen attention to detail and the ability to work in compliance with current Good Manufacturing Practice (cGMP) guidelines are crucial for this position.

Key Responsibilities:

  • Conduct quality assurance evaluations of kitting and dispensing records in line with Good Documentation Practices (GDP).
  • Assist in the management of Mirus Bio documentation, including scanning and maintaining quality files both on-site and for off-site storage.
  • Verify the accuracy and legibility of final product labels for production and shipping, ensuring complete product traceability.
  • Oversee the adherence to procedural requirements for quality operations activities, such as lab cleanings and equipment calibrations, and coordinate with relevant departments to address any identified gaps.
  • Support the Quality, Production, and Shipping teams in executing straightforward cross-functional processes and activities.
  • Facilitate effective communication across teams to remove barriers and ensure alignment with all partners.
  • Adapt swiftly to changing priorities and manage multiple tasks with potentially overlapping deadlines.
  • Ensure compliance with Good Documentation Practices (GDP) and current Good Manufacturing Practices (cGMP) for assigned responsibilities.
  • Maintain a safe laboratory environment by adhering to Biological Safety Level 2 (BSL-2) guidelines and standard laboratory practices.
  • Foster positive relationships during both internal and external interactions.
  • Exhibit behaviors consistent with the Mirus Bio Employee Handbook.
  • Perform additional duties as assigned by the Senior Quality Manager.

Qualifications:

Education:
High School Diploma or GED is required.

Professional Experience:
Demonstrated experience in maintaining quality assurance processes. Ability to work in an organized manner, make critical observations, and keep accurate records. Strong verbal and written communication skills are essential. Proven problem-solving abilities and the capacity to work effectively in a team environment are required. Candidates should be comfortable working in a laboratory setting and able to lift up to 25 lbs occasionally.

Compensation:
This position offers a salary range of $20 - $25 per hour, commensurate with experience.

Core Values:
Mirus Bio is guided by our core values: Empower, Passion, Integrity, Compassion, Collaboration, and Innovation. Our commitment to these values drives our mission to provide the best transfection products and services to our customers and the scientific community.

Equal Opportunity Employer:
Mirus Bio is an equal opportunity employer dedicated to diversity and inclusion in the workplace. We prohibit discrimination and harassment based on any protected characteristic as outlined by federal, state, or local laws.

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