Quality Control Associate

Find what drives you on a team with a more than 70-year history of discovery, determination, and innovation. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers protect people. Our products serve a wide range of markets, so if your interests lie along the spectrum of Life Sciences to Industrial, you'll find a rewarding role here. For the exponentially curious, Pall is a place you can thrive and amplify your impact on the world.

Pall is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we're pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

About Precision NanoSystems Inc. (PNI)

Precision NanoSystems Inc., part of Pall Corporation, is a biotechnology company that creates innovative solutions for the discovery, development and manufacture of novel nanoparticles for use as medicines and in medical research. PNI's proprietary NanoAssemblr® microfluidics platform and GenVoy® lipid nanoparticle delivery platform enable the rapid, reproducible, and scalable manufacture of next generation nanoparticle formulations for the targeted delivery of therapeutic and diagnostic agents to cells and tissues in the body. Our overall goal is to accelerate the creation of transformative medicines that significantly impact human well-being.

What you'll do

Draft SOPs, test methods, specifications and protocols applicable to the QC group

Implement and conduct test methods for raw materials, lipid excipients, RNA-based APIs, lipid nanoparticle (LNP) formulations and other materials used in the production of GMP nanomedicines

Complete equipment onboarding processes for QC equipment

Conduct method qualification or verification activities as applicable for test methods

Conduct activities in compliance with all applicable SOPs and follow good documentation practices

Lead all aspects of QC sample handling and management, conduct sampling as required to enable testing and / or for retention

Oversee QC reference standards and materials / consumables to ensure sufficient supplies and uninterrupted QC lab operations

Coordinate sample shipments to external testing labs, communicate material and testing requirements

Conduct review and trend data as applicable, ensure appropriate documentation handling / filing

Draft QC study and qualification / verification protocols and reports

Conduct QC lab operations as the need arises and ensure QC lab safety / cleanliness standards are met

Work closely with the Clinical Manufacturing team members to complete testing in a timely manner and resolve issues

Initiate and participate in deviations, OOS and investigations otherwise, corrective and preventative actions (CAPAs)

Mentor and train other QC personnel on lab operations and test methods as applicable

Perform other duties as assigned

Who you are

Minimum BSc in Pharmaceutical Sciences or relevant field with at least 2 years of industry experience in Quality Control or Analytical Development in a GMP regulated environment

Experience with testing and characterization of lipid nanoparticles is preferred

Experience using a range of analytical equipment including HPLC / UPLC, CE, GC, DLS particle sizer, plate reader, UV / vis, pH meter, osmometer, Karl Fischer, etc. an asset

Strong Technical Writing Skills Are Required

Must be a resourceful, proactive, detail-oriented individual and a great teammate who is adaptable to a dynamic environment with challenging timelines

Good communication, organizational and time-management skills

A proven ability to troubleshoot and solve complex technical issues

Ability to handle multiple tasks in a fast-paced environment

Highly organized with outstanding attention to detail

Self-motivated and independent work ethic

An ideal candidate is committed to developing their technical skills while contributing to PNI's internal and client programs

When you join us, you'll also be joining Danaher's global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

If you've ever wondered what's within you, there's no better time to find out.

Skills Required

Hplc, Ce, dls, Ph Meter, Analytical Development, osmometer , Uplc, Uv Vis, Gc, Quality Control