Quality Control Associate

Frederick, Maryland
Sep 10, 2020
Oct 15, 2020
Career Level
Entry Level
Full Time

What's your why?

Ours is to create a world where safe and effective regenerative medicines are rapidly developed and are widely available on a global scale, to benefit the lives of patients in need.

RoosterBio, Inc. is a privately held cell manufacturing platform technology company based in Frederick, MD that is focused on accelerating the development of a sustainable Regenerative Medicine industry, one customer at a time. RoosterBio's products are high-volume, cost-effective, and well-characterized adult human mesenchymal stem/stromal cells (hMSCs) paired with highly engineered media systems. RoosterBio has simplified and standardized how living cells are purchased, expanded, and used in development, leading to marked time and cost savings for customers. RoosterBio's innovative products and collaborative relationships are ushering in a new era of productivity and standardization into the field.

We are proud to have been recently named a regional Top Workplace by The Washington Post!

The Role

We are looking for a friendly, well organized, highly motivated and driven individual to join the team at RoosterBio and fill a role focused on building and optimizing our quality control operations as well as enhancing our culture. This position is critical to the RoosterBio business with responsibilities in quality control assay execution, which is a key part to our customers having a good experience with our products. We are looking for a team-oriented person who can take on increasing responsibilities as RoosterBio continues its high growth trajectory.

Primary Responsibilities

  • Execute quality control assay testing for product lot release and stability studies.
  • Collaborate with external QC testing labs, including protocol generation, sample distribution, and sample analysis receipt.
  • Collaborate with development team and other internal stakeholders for the Method Qualification and Method Transfer of new products and assays into the quality control group and/or to external CTOs .
  • Draft, review, update and execute quality control test records with good documentation practices.
  • Execute data analysis and visualizations using standard software (Excel, GraphPad, etc).
  • Perform root-cause analysis for all out of specification reports and deviations. Develop and implement corrective and preventative actions (CAPAs).
  • Manage and execute basic laboratory activities including inventory management, equipment monitoring and maintenance, etc.
  • Maintain lab space following Lean/5S/Six Sigma methodologies.
  • Establish and manage QC metric, data trending, and drive actions for improvement.

Desired Skills/Qualifications:

  • B.S./M.S./Ph.D. with 1-5 years of relevant industry experience
  • Lab experience in Biotechnology, Medical Devices or Cell Biology industry.
  • Experience in mammalian cell culture and cell based assays is preferred.
  • Poses scientific knowledge and comprehensive understanding of regulatory guidelines to ensure all testing is performed in a compliant manner
  • Experience working in an ISO/GLP/GMP environment preferred.
  • Candidate must be eligible to work in the U.S for other than practical training.