Ref No.

QA-20-76

Location

US ~ Garnet Valley, PA

QA Associate-Clinical

Company Overview

Our growing and successful business comprises of over 800 talented individuals globally, in an environment where everybody counts and is instrumental to our success.  With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.

People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.

 

The Role

The QA Associate will support the QA Specialists on projects providing early phase pharmaceutical formulation, development and clinical trial manufacturing support to our clients.  The majority of projects will involve oral solid dosage pharmaceutical products in various stages of development, from pre-formulation through registration.  The QA Associate will support the development and implementation of an efficient and effective quality management system, maintain open and timely communication across the team, and visibly demonstrate the behaviors necessary to maintain compliant GMP practices and advance the quality culture.

Main tasks and responsibilities will include:

  • Support the QA Specialists that serve as project teams for early phase pharmaceutical formulation, development and manufacturing in support of clinical trials by:
    • Participating in project meetings.
    • Reviewing and providing feedback on pharmaceutical development reports, equipment qualifications, analytical method qualifications, process verifications, stability study documents, risk assessments, product specifications, and SOPs. 
    • Distributing fully reviewed and executed quality documents and records to customers in accordance with company procedures.
  • Participate in supplier quality assessments to ensure suppliers and subcontractors to be used for the clinical product are properly qualified in accordance with the supplier management program.   
  • Provide QA support and oversight to the production of clinical trial material to ensure that product is manufactured in accordance with specifications and GMP requirements.
  • Review and release raw materials and components to be used in the manufacture of clinical trial material.  
  • Generate, review and issue labels for clinical trial manufacturing/formulation development.
  • Review executed batch records, analytical test results and raw data, and provide input to QA Specialists for their product release.  As required, work to resolve identified issues to support timely release of product that conforms to specifications. 
  • Support investigations related to deviations, out-of-specifications or atypical results related to the clinical trial product and the implementation of corrective and preventive actions that mitigate potential for issue recurrence.   
  • Communicate quality-related information and data to project teams. 
  • For products moving from early to late stage, participate in tech transfer activities to support customer registration, scale up, validation and commercialization readiness.
  • Participate in the planning and execution of customer audits.  As required, support the compilation of responses to customer audit findings to assure they are submitted to customers on time. 
  • Participate in regulatory inspections to ensure successful results.
  • Provide work product that meets the highest quality standards by ensuring work is accurate and delivered in accordance with established timelines.  Keep the QA Specialists informed on the status of project-specific activities.
  • Perform other duties as assigned.

Job Demands

The job may involve the following:

  • Working to tight deadlines.
  • Having to juggle a range of tasks/issues simultaneously.
  • Working in a hazardous environment with high requirement to follow safety procedures.
  • Working outside normal working hours.
  • Needing to respond to client demands.

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.
  • Must be able to qualify for respiratory protective equipment use.

 

The Candidate

  • Associate degree in a scientific field, or equivalent experience
  • Minimum three (3) years’ related experience in QA or QC in life sciences
  • Good understanding of CGMP requirements
  • Good organization and time management skills
  • Effective written and oral communication skills
  • Good interpersonal skills with a special focus on customer satisfaction.

 

Company benefits

In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.

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