Intern, Clinical QA

Job Title:Intern, Clinical QA
Location US ~ Boothwyn, PA
Type: Internship (US)

Company Overview

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients.

As a growing and successful business, we employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.

Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.

The Role

  • The Summer Intern will support the QA Specialists and QA Associate on projects providing early phase pharmaceutical formulation, development, and clinical trial manufacturing support. The internship will last 12 weeks and will provide a chance to see quality procedures that support drug release at Quotient.  Candidate should have a strong interest in working in the pharmaceutical field.

Main tasks and responsibilities

  • Support the supplier quality program by contacting suppliers, sending questionnaires, following up on responses/gaps.
  • Evaluation of low-risk suppliers through creation of basic assessments to ensure all minimum criteria are met.
  • Support the execution of supplier quality agreements by contacting the supplier, sending the Quotient quality agreement template, and following up on comments and responses.
  • Additional Tasks/responsibilities   
  • Support the Documentation Group with administrative tasks, as appropriate.
  • Support with following up on open Quality Event status and open internal/customer audit observations requiring responses, as appropriate.
  • Support the QA team by reviewing documents. Verifying data against source documents.
  • Review analytical methods, protocols, and reports with the guidance of quality assurance staff.
  • Reviewing pharmaceutical development reports, equipment qualifications, analytical method qualifications, process verifications, stability study documents, risk assessments, product specifications, and SOPs. Feedback will be provided to the Clinical QA team member.
  • Training in reviewing Batch records, checking manufacturing supplies listed.
  • Review of Inventory folders for completeness and archiving older folders
  • Provide support for labels and QA inspection of finished products.
  • Review and release raw materials and components to be used in the manufacture of clinical trial material.  
  • Support QA Specialist and Senior Specialist with the review of raw material specifications and COAs,
  • Training by QA Specialists and Senior Specialist in writing quality incidents
  • Exposure to investigations related to deviations, out-of-specifications or atypical results related to the clinical trial product.  Exposure to the process of Root Cause Analysis  

Job Demands

The job may involve the following:

  • Very high concentration of work
  • Strict and tight deadlines
  • Having to juggle a range of tasks/issues simultaneously
  • Working in a hazardous environment with high requirement to follow safety procedures
  • Communicate with Clinical Team any errors that is critical and may impact quality.

Physical Demands

  • While performing the duties of this job, the employee is frequently required to stand and walk
  • The employee is occasionally required to sit, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl.
  • The employee must occasionally lift and/or move up to 10 pounds.
  • Specific vision abilities required by this job include close vision, color vision and ability to adjust focus.

The Candidate

  • Currently enrolled student pursuing a Bachelor or Masters in a scientific field e.g. Biology, Biochemistry, Pharmaceutical Sciences, Chemical/Biological Engineering
  • Applicant should be available to work full time for 12 weeks beginning in June 2021
  • Applicant should have completed 2 years of studies toward a Batchelors degree. 
  • Good organization and time management skills
  • Good written and oral communication skills
  • Research courses, and lab classes with exposure to instrumentation, interpretation of data and lab safety practice.
  • Good interpersonal skills with a special focus on customer satisfaction.