Quality Assurance Specialist

Watertown, MA /
Quality Assurance /
Full Time
The Opportunity
This is your opportunity to join a highly driven and ambitious young company that values collaboration, respect, intellectual curiosity, and integrity in our endeavor to transform the way cell therapies are developed and to expand the field of platelet-derived therapeutics. Inspired by platelet biology, we have developed a scalable, cGMP-compliant cell culture platform to make engineered human pluripotent stem cell-derived megakaryocytes and platelets.  This is an exciting time to join PB as we further scale production for human clinical trials and leverage our platform for cell-based drug delivery opportunities. 
 
Our Ideal Candidate
Quality Assurance is looking to build out its team to support the process of advancing program and manufacturing efforts. We are looking for a highly motivated individual with experience working in a GMP manufacturing facility and with performing product release activities. Our ideal candidate is a someone with excellent attention to detail, strong independent work skills, and a desire to work in a fast-paced environment. Come join our growing team today to truly improve the quality of life of patients.   

Role and Responsibilities

    • Support GMP production activities and documentation, such as release of cleanroom, review of EM data, audit of logbooks
    • Issue and review manufacturing batch records and associated documentation
    • Review, manage, and track quality events such as Deviations, CAPA, and Change controls
    • Provide support and approval of risk assessments, including FMEA (Failure mode and effects analysis)
    • Qualify suppliers and manage vendor relationships
    • Provide quality oversight and training of manufacturing personnel 

Preferred Skills and Qualifications

    • 5+ years’ experience in a GMP environment with a Bachelor’s degree in a scientific discipline such as chemistry, biology, Bioengineering, or related field
    • Previous experience with QA activities surrounding drug substance and drug product release
    • Working knowledge of cGMPs and Part 11 compliance, including use of electronic quality management systems
    • Ability to work with others in a group environment as well as work independently with minimal supervision
    • Excellent written and oral communication to include accurate and legible documentations skills and proficiency in Microsoft Office (Word, Excel, etc.)
    • Detail oriented with strong critical thinking skills 
The Company
PlateletBio, located in Watertown, MA, is a venture-backed biotech startup that was spun out of Harvard Medical School to produce allogeneic cell therapies from engineered induced pluripotent stem cells (iPSCs).
 
As an equal opportunity employer, Platelet Bio does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin or veteran status.  We value diversity and are committed to creating an inclusive environment for team members from all backgrounds.