Quality Assurance Specialist II

Highly Competitive
  1. Permanent
  2. Good Pharmacovigilance Practice (GVP)
  3. United States
Brooklyn Park, Minnesota
Posting date: 04 Apr 2019

ProClinical are currently advertising with a leading global pharmaceutical company that specialises in multiple therapy areas. They are currently looking to recruit a Quality Assurance Specialist II to work in Minnesota. The organisation offers an excellent rate of pay and have a strong reputation as an excellent company to work for.

The Quality Assurance Specialist will perform Quality Assurance activities associated with commercial cGMP biologics drug substance manufacture at the company's site. They will be responsible for review of batch records and associated documentation in support of timely commercial drug substance batch disposition. They will also provide assistance to site personnel performing deviation investigations, CAPAs and change controls.

Job Responsibilities:

  • Performing thorough documentation reviews, with a high attention to detail, using working knowledge of quality concepts, internal procedures, and controls.
  • Supporting GMP compliance with time spent in the Manufacturing environment on a regular basis.
  • Analyzing and interpreting projects, studies, or investigations to determine next steps in consultation with Supervisor; Making basic decisions independently and reviewing more complex decisions with management.
  • Identifying and resolving basic technical issues using problem-solving skills, in consultation with Supervisor.
  • Assessing deviations assigned a direct root cause, defining CAPAs and entry-level change controls.
  • Independently revising department-specific controlled documents.
  • Participating in required training and keeping training files current.
  • Identifying and proposing Quality Process and system improvements.

Skills and Requirements:

  • BA/BS (or Master's) in any Life Science discipline preferred.
  • 3-5 years of experience in Regulated (food, medical device, or pharma/biotech) industry.
  • A thorough understanding and working knowledge of quality and GMP principles.
  • 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.
  • Proficiency with computer skills, such as 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 Kevin Cassini at +1 215 531 5288 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.