- 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.
- 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.
-
Quality/Clinical Trial Associate
1 week ago
Pacific Edge Hummelstown, United StatesPacific 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. · ...
-
Quality/Clinical Trial Associate
3 days ago
Pacific Edge Hummelstown, United StatesJob Description · Job DescriptionPacific 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 ...
-
Research Project Manager
2 days ago
Penn State University Hershey, United States**JOB DESCRIPTION AND POSITION REQUIREMENTS**: · The Penn State College of Medicine, Office of the Vice Dean for Research, in Hershey, PA is seeking a Research Project Manager to oversee a nd manage a large, complex strategic initiative. · Working with the Office of the Vice Dean ...
-
Nurse Practitioner
5 days ago
Lancaster General Health Lancaster, United States**Summary** · Penn Medicine - The Heart Group of Lancaster General Health is seeking a full-time Nurse Practitioner to join our Heart Failure and Ventricular Assist Device (VAD) team. As part of a highly productive cardiology group consisting of 28 Physicians and 27 Nurse Practit ...
-
U.S. Army War College Carlisle Barracks, United States**Duties**: · - You will serve as the Emerging Technology, Data and Artificial Intelligence Post-Doctoral fellow. · - Conduct research on these topics and contribute to the development, planning, and teaching of core and elective courses in the Resident Education Program and asso ...
-
Customer Care Supervisor
6 days ago
Pacific Edge Hummelstown, United StatesJob Description · Job DescriptionPacific 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 ...
-
RN Clinical Research Cancer
1 day ago
Penn State Health Hershey, PA, United States**Penn State Health** - **Hershey Medical Center** · **Location:** US:PA:Hershey · **Work Type:** Full Time · **FTE:** 1.00 · **Shift:** Day · **Hours:** 8:00a - 4:30p · **Recruiter Contact:** Denisse M. Rosado at ) · **SUMMARY OF POSITION:** · Under the direction of the Cancer ...
-
clinical trials data specialist
1 week ago
Penn State Health Hershey, PA, United States**Penn State Health** - **Hershey Medical Center** · **Location:** US:PA:Hershey · **Work Type:** Full Time · **FTE:** 1.00 · **Shift:** Day · **Hours:** 8:00a - 4:30p · **Recruiter Contact:** Denisse M. Rosado at (//%7BRecruiterEmailAddress%7D) · **SUMMARY OF POSITION:** · Resp ...
-
Research Project Manager
2 weeks ago
Pennsylvania State University Hershey, United StatesAPPLICATION INSTRUCTIONS: · + CURRENT PENN STATE EMPLOYEE (faculty, staff, technical service, or student), please login to Workday to complete the internal application process \_sU3KzTmERfpryq0esPKQ) . Please do not apply here, apply internally through Workday. · + CURRENT PENN S ...
-
associate clin research i
1 week ago
Penn State Health Hershey, PA, United States**Penn State Health** - **Hershey Medical Center** · **Location:** US:PA:Hershey · **Work Type:** Full Time · **FTE:** 1.00 · **Shift:** Day · **Hours:** 8:00a - 4:30p · **Recruiter Contact:** Hector Diaz at (//%7BRecruiterEmailAddress%7D) · **SUMMARY OF POSITION:** · Responsibl ...
-
histology associate
1 week ago
Penn State Health Hershey, PA, United States**Penn State Health** - **Hershey Medical Center** · **Location:** US:PA:Hershey · **Work Type:** Full Time · **FTE:** 1.00 · **Shift:** Varied · **Hours:** day · **Recruiter Contact:** Rebecca L. Stuckey at ) · **SUMMARY OF POSITION:** · Responsible to perform basic histology d ...
-
Medical Oncologist
1 week ago
Penn State Health Hershey, United States**Penn State Health - Milton S. Hershey Medical Center** · **Location** : US:PA:Hershey · **Work Type** : Full Time · **FTE** : 1.0 · **Shift** : Varied · **Hours** : Varied · **Recruiter** : Please contact Erica Moyer at for additional information. · The Division of Hematology/ ...
-
Penn State University Hershey, United StatesAPPLICATION INSTRUCTIONS: CURRENT PENN STATE EMPLOYEE (faculty, staff, technical service, or student), please login to Workday to complete the internal application process. Please do not apply here, apply internally through Workday. · CURRENT PENN STATE STUDENT (not employed pre ...
-
Division Chief
1 week ago
Penn State Health Hershey, United States**Penn State Health** - **Hershey Medical Center** · **Location:** US:PA:Hershey · **Work Type:** Full Time · **FTE:** 1.0 · **Shift:** Day · **Hours:** 40hr · **Recruiter Contact:** Please contact Patty A. Shipton at (//%7BRecruiterEmailAddress%7D) for additional information. · ...
-
Pennsylvania State University Hershey, United StatesAPPLICATION INSTRUCTIONS: · CURRENT PENN STATE EMPLOYEE (faculty, staff, technical service, or student), please login to Workday to complete the internal application process ) . Please do not apply here, apply internally through Workday. · CURRENT PENN STATE STUDENT (not employed ...
-
Teachers at Hershey KinderCare
3 days ago
KinderCare Education Hershey, United StatesFutures start here. Where first steps, new friendships, and confident learners are born. At KinderCare Learning Companies, the first and only early childhood education provider recognized with the Gallup Exceptional Workplace Award, we offer a variety of early education and child ...
-
Medical Oncologist
2 weeks ago
Penn State Health Hershey, PA, United StatesPenn State Health - Milton S. Hershey Medical Center · Location : US:PA:Hershey · Work Type : Full Time · FTE : 1.0 · Shift : Varied · Hours : Varied · Recruiter : Please contact Erica Moyer at for additional information. · The Division of Hematology/Oncology and Pen ...
-
Clinical Development Medical Director
1 week ago
Novartis Grantville, United StatesSummary · Onsite Location: East Hanover, New Jersey Hybrid About the role: Over 108,000. That's how many US patients our oncology products touched in 2018. Novartis is deeply committed to transforming the lives of people living with solid tumors, blood cancers and serious or life ...
-
Teamsters Clerk III
1 week ago
Dauphin County, PA Harrisburg, United StatesDauphin County Clerk of Courts is currently accepting applications for the full-time position of Teamsters Clerk III. An employee in this position receives, records, routes, and/or files legal documents associated with adjudicated traffic violations, observing applicable calendar ...
-
Executive Administrative Assistant I
6 days ago
Pennsylvania Office of Attorney General Philadelphia, United StatesSalary: See Position Description · Location : Philadelphia, PA · Job Type: Full-time · Remote Employment: Flexible/Hybrid · Job Number: · Division: Public Protection Division · Section: Fair Labor Section Philadelphia · Opening Date: 04/16/2024 · Closing Date: 4/30/2024 11:59 PM ...
Quality/Clinical Trial Associate - Hummelstown, United States - Pacific Edge Inc
6 days ago
Description
Pacific Edge Cancer Diagnostics CompanyOur 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:
