Operations Quality Systems Specialist

Req ID:  112971
Location: 

Ballina, IE, F26D786

For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

 

JOB TITLE:   Operations Quality Systems Specialist

 

Main Duties & Responsibilities:

  • Responsible for the processing of all Analytical Services Department Quality Documents, i.e. Deviations, LIRs, Facility replies, audit responses, change controls, etc.
  • Tracking and applying corrective/preventive actions and checking effectiveness of same.
  • Assessing the impact of changes to facilities/systems/equipment and processing of change control documents.
  • Liaise with the Quality Assurance Department to process quality documents.
  • Generate new and update current standard operating procedures if required by CAPA
  • Assist with the implementation of systems to improve Quality and raise Quality awareness among staff in the Analytical Services Department. 
  • Review of data.
  • Dealing with internal and external customers as required.
  • Involvement with regulatory and client audits as required.

 

PERSON SPEC:

 

The successful candidate must have:

  • Scientific/Quality Systems qualification.
  • 2--4 years’ experience of working in a Medical Device/Pharmaceutical/CRO industry i.e. GMP/Quality experience.
  • GMP background essential.  Comprehensive understanding of GMP compliance and how it relates to the quality system.
  • IT skills – MS Word, Excel, Powerpoint etc.
  • Meticulous attention to detail and high level of accuracy.
  • Excellent problem-solving skills.
  • Excellent interpersonal & communication skills, both written and verbal.
  • Positive attitude
  • Excellent report writing skills.
  • Ability to work on own initiative as well as part of a team.
  • Flexibility - Ability to work overtime as required.
  • Technical knowledge of Analytical testing is essential, with particular focus on HPLC/UPLC systems and knowledge of Empower 3

 

 

Job Summary

Performs technical laboratory activities in support of client studies or procedures. Performs analysis of data for quality and completeness and determines if results are as expected. Records data in compliance with company and regulatory policies and standards to meet quality and accuracy requirements.

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About Biologics Testing Solutions
With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterzation, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs.  Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.

 

About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

With over 14,000 employees within 80 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2018, revenue increased by 22% to $2.27 billion from $1.86 billion in 2017.

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of ~85% of the drugs approved by the FDA in 2018.