Quality Batch Record Review

US$80 - US$115 per hour
  1. Permanent
  2. Project Management
Chicago, Illinois
Posting date: 01 Mar 2019

ProClinical is partnering with a leading biotechnology company to advertise a vacancy for a Quality Batch Record Review position. This organisation is a top 100 recognised leader in medical diagnostic and global clinical trial testing services and prides itself in its customer-focused approach. This is an exciting opportunity for a driven and experienced applicant to join their team in Illinois.

Job Responsibilities:

  • Reviewing over 1000 batch records, ensuring that they are up to proper GMP and regulatory standards.
  • Investigating and addressing batch issues, including EM, Process, product, manufacturing, and raw materials.
  • Passing any findings over to the investigational teams, and providing any support required

Skills and Requirements:

  • A Bachelor's degree is required.
  • Expertise in Quality/GMP fields.
  • Demonstrable experience with sterile/aseptic processes.
  • Exposure to multiple areas across Quality - Process, EM, Product, Manufacturing, and raw materials.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Prepared to work hard to meet ambitious deadlines and exceed clients' expectations
  • Proficiency in MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Keri Marshall at +44 207 440 0679 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.