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Quality/Clinical Trial Associate

4 months ago

Hummelstown, United States Pacific Edge Full time
Pacific Edge Cancer Diagnostics Company

Our People: Our strength is in our people. We believe hard working, dedicated people make a significant difference.

Our Goal: To deliver actionable results that can contribute to a clinically meaningful difference in cancer treatment.

Our Focus: The development of state-of-the art diagnostics and prognostics

Our Motivation: To meet and exceed expectations; never stand still and or accept second best.

Under the guidance of the Quality Control Manager, the Quality/Clinical Trial Associate is a hybrid role that is responsible for helping to ensure all aspects of the quality control system are being performed per company procedures and regulatory requirements. Additionally, the Quality/Clinical Trial Associate will be responsible for being the laboratory lead on clinical trial coordination and testing as well on key laboratory process improvement initiatives where applicable. The position must maintain patient and company confidentiality and adhere to all compliance, regulatory, and company procedures and policies.

The incumbent must have a bachelor's degree in medical technology, chemical, physical, or biological sciences and at least five (5) years of molecular and/or clinical laboratory experience.   Must have significant QC experience in a regulated laboratory environment such as a CAP/NYSDOH-accredited clinical laboratory; quality certification preferred.

This role is located in our Hummelstown, PA laboratory and offers a hybrid working schedule.

Some of the key responsibilities of the position include, but are not limited to, the following:
 
  • Ensure equipment maintenance is performed on a monthly basis including, but not limited to, temperature and humidity trends, OOS equipment, and cleaning and equipment maintenance performed on a monthly basis.
  • Assist in preparation and analysis of quality control section of the monthly report and assist in the preparation of the quarterly Quality Report including all Quality Indicators.
  • Qualify vendors for PEDUSA laboratory products.
  • Track the receipt, quarantine, release and rejection of laboratory reagents, plasticware or controls provided by PEL Operations for laboratory use. Obtain quality documents. Determine if a reagent/plasticware etc  should be released or rejected. Ensure products are properly labeled.
  • Design and perform reagent qualifications.  Release reagents for use and update the Lot Number Log. Ensure all reagents used to manufacture products are appropriate in type, grade and concentration; and within expiration date. Ensure all reagent labeling is correct. Ensure the correct reagent expiration date is assigned to the manufactured reagent. Ensure all calculations used in manufacturing the reagent are correct.
  • Design, analyze and prepare reports for process updates and validations.
  • Organize and pull proficiency testing samples for sample exchanges among and between PEDUSA and PEDNZ.
  • Organize and prepare credentialing and licensing renewals.
  • Prepare lab for biannual CAP, NY-DOH inspections and future FDA regulations.
  • Write, review and update Clinical Trial laboratory-related SOPs for PEDUSA.
  • Creation and monitoring of USS and study specific spreadsheets and any additional forms uploaded to the Clinical Group Data Sharepoint. Monitoring Mantis/JIRA for clinical trial issues and ensuring they are followed up in a timely manner.
  • Assists in the creation of PEDUSA SOW, TRFs and any additional documentation required for new sites and studies and integration into the PEDUSA process.
  • Serve as laboratory point of contact for clinical trials tracking, testing and coordination with clinical sciences team.
  • Training PEDUSA staff in the requirements for clinical studies as well as performance of the requirements.

Skills Required:
  • Required experience with clinical (commercial and clinical trial) sample processing/testing in a commercial laboratory.
  • Required regulated environment experience (CLIA, FDA, CAP, GLP, and NYS-DOH).
  • Experience with aseptic technique, DNA/RNA extraction, RT-qPCR, ddPCR and robotic automated liquid handlers.
  • Excellent judgment, organizational skills, and problem solving abilities.
  • Capable of working independently and with a team. Ability to complete tasks on time with minimal supervision.
  • Strong verbal and written communication skills.
  • Basic computer skills-Microsoft Excel, Word and Adobe are required, LIMS preferred.
  • Previous Quality Control/Quality Assurance experience.


Pacific Edge Diagnostics USA is an Equal Opportunity Employer - all are encouraged to apply

 

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