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Career Opportunity

Quality Assurance Specialist

Department: Quality
Posting Date: 08/10/2021

Position Purpose
Perform document control and quality assurance review of the Mirus Bio product portfolio to maintain a high level of quality and performance.

Duties and Responsibilities

Essential Duties:
  • Maintain and coordinate revision of all version-controlled documents in the quality system.
  • Perform quality review of data generated by all departments for completeness, accuracy and compliance.
  • Review and release raw materials, intermediate products and finished products.
  • Maintain supplier quality including qualifying new suppliers and requalifying current suppliers.
  • Maintain audit schedule and ensure audits are performed as required.
  • Maintain training records for all employees.
Other Duties:
  • 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.
  • 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.

Skills Set

Essential Skills:
  • Bachelor of Science (B.S.) degree or higher in Biology or related field and 2 years of relevant experience working in a cGMP environment.
  • 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.
Preferred Skills:
  • At least 5 years’ experience.
  • 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.

Mirus Bio LLC offers a competitive benefits package including Health / Dental insurance, paid time off (vacation / personal), profit sharing, 401k.

COVID vaccination is required for all new employees, but Mirus is committed to following the mandates of the Americans with Disabilities Act and will consider accommodations for disability and religious based reasons.

The preceding functions have been provided as examples of the types of work to be performed for 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 requirements listed above are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Mirus Bio LLC is an Equal Opportunity Employer.

Mirus is a team-oriented company where we work to carry out our mission to: Deliver Innovation. Empower Discovery. Improve Life. At the heart of our mission is our passion to give our customers and the scientific community the best transfection products, methods and applications.

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