Quality Assurance Specialist

4 weeks ago

Madison, United States Mirus Bio, LLC Full time
Job DescriptionJob DescriptionJOB SUMMARY

For over 25 years, Mirus Bio pioneered the manufacture of transfection reagents and proprietary technologies for nucleic acid delivery applications. Despite our extensive experience, we pride ourselves on maintaining the spirit of a startup. Our dynamic and forward-thinking approach has allowed us to stay agile and adapt to emerging trends. Our work is technical and cutting-edge, and we promote a culture of that encourages creativity, initiative, responsibility, and respect. Our team members are engaged and motivated by the desire to support our customers to practice good science to generate strong results. Mirus, together with Gamma Biosciences, is establishing the future of science and medicine by developing products that enable researchers within the cell and gene therapy space.

OUR MISSION: Empower Discovery. Enable Innovation. Improve Life.

Mirus Bio is expanding and has an immediate opening for a Quality Assurance Specialist to perform document control and quality assurance review of the Mirus Bio product portfolio to maintain a high level of quality and performance. The responsibilities outlined below may fluctuate depending on the number of projects and current business priorities.

We are currently on the lookout for a hands-on individual to join our passionate team. If you are someone who thrives in a collaborative, innovative, and fast-paced environment, join us in shaping the future of our industry and be a part of a team that continues to redefine possibilities. This engagement estimated to be 6-9 months and is a full-time on-site position. This role works cross-functionally with all departments within Mirus Bio.

DUTIES & RESPONSIBILITIES
  • Assist with revision of all version-controlled documents in the quality system
  • Perform quality review of labels and data generated by all departments for completeness, accuracy and compliance
  • Review and release raw materials, intermediate products and finished products
  • Create and approve of product specific quality documentation such as Certificates of Analysis, Certificates of Origin and product questionnaires
  • Assist with supplier quality including qualifying new suppliers and requalifying current suppliers
  • Maintain training records for all employees
  • Assist with revisions to quality procedures and process improvements
  • Assist with onsite audits by customers or regulatory agencies
  • Manage deviations, investigations, change controls and CAPAs to ensure timely closure
  • Assist with review of customer complaints and inquiries as required
  • Serve as a subject matter expert on Qualio electronic quality management system
  • Perform quality related activities in Mirus inventory system and temperature monitoring systems
  • Serve as a back-up for various quality responsibilities as needed
  • Follow GMP guidelines and ensure quality compliance
  • Interface and work amicably with other departments including facilities, shipping, production and R&D within Mirus
  • Share information with fellow employees
  • Build positive relationships during internal and external interactions
  • Represent the company in a positive and professional manner
  • Demonstrate behavior outlined within the Mirus Bio Employee Handbook
  • Perform other duties as assigned by Sr. Quality Manager
REQUIREMENTS
Education:
  • Bachelor of Science (B.S.) degree or higher in Biology or related field and 2 years of relevant experience working in a cGMP environment
  • At least 5 years’ experience preferred

Professional:
  • Experience with quality document review
  • Ability to work productively in a team environment
  • Capability to work in an organized manner, to make critical observations, and to maintain good records of the results
  • Excellent verbal and written communication skills
  • Proficiency with Microsoft Office including Excel, Word and PowerPoint
  • Experience with maintaining and/or qualifying suppliers
  • Experience or qualification to perform quality auditing
  • Previous experience working for a life sciences company is preferred
  • Experience with cell biology techniques such as, mammalian tissue culture and transfection

This position has a salary range of $60,000 to $75,000 and will be commensurate with experience.

OUR CORE VALES
Mirus Core Values:
 
  • Empower
  • Passion
  • Integrity
  • Compassion
  • Collaboration
  • Innovation

Our passion is at the heart of our mission to give our customers and the scientific community the best transfection products, methods, and applications. 

Mirus benefits include non-compensation benefits like health care, paid time off, retirement savings, and professional development.

Mirus Bio is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training. Mirus Bio makes hiring decisions based solely on qualifications, merit, and business needs at the time.

The preceding functions have been provided as examples of the types of work performed by employees assigned to this job classification. Management reserves the right to add, modify, change or rescind work assignments and to make reasonable accommodations as needed. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The job requirements for the positions listed above are representative of the knowledge, skills and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
 

EEO/AA Statement

Mirus Bio is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits and training. Mirus Bio makes hiring decisions based solely on qualifications, merit, and business needs at the time.

Accommodation Statement

Mirus Bio is committed to the inclusion of all qualified individuals in the hiring process, including but not limited to those with disabilities. If you require reasonable accommodation(s) to participate in the application or interview process, please contact HR@mirusbio.com.

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