Quality Assurance Specialist III

Highly Competitive
  1. Permanent
  2. Good Pharmacovigilance Practice (GVP)
  3. United States
Cambridge, Massachusetts
Posting date: 19 Feb 2019

ProClinical is advertising a vacancy for a Quality Assurance Specialist III position with a leading international pharmaceutical company that specialises in multiple therapy areas. This prestigious organisation is seeking for the incumbent to join their team in Massachusetts.

The Quality Assurance Specialist III will perform lot review/release activities for commercial drug substance, drug product, and finished goods. They will also act as the lead Quality contact for CMOs. This is an exciting opportunity for an experienced and outstanding individual to join a company with a superb record of employee and client satisfaction.

Job Responsibilities:

  • Providing QA review and disposition of commercial lots of drug substance, drug product, and finished goods.
  • Distributing work to QA staff to assure timely review of batch documentation.
  • Generating and reviewing deviations and investigations to assess cGMP compliance of lots.
  • Leading off-site visits and teleconferences for discussion and reviewing supplier performance to established schedules and cGMP compliance.
  • Initiating, monitoring, and completing change controls related to Quality topics.
  • Reviewing and approving supplier documents requiring Quality approval.
  • Initiating, revising, and reviewing controlled cGMP documents, including SOPs, Material Specifications, Investigation protocols/reports, and Process Validation protocols/reports as applicable.
  • Providing training on department specific procedures and systems.
  • Collecting and calculating data and reporting on departmental performance metrics.
  • Identifying and proposing Quality process and system improvements.
  • Leading improvement projects.
  • Serving as QA representative to cross functional project teams such as tech transfer, process validation, and process improvements.
  • Leading Investigation teams and ensuring proper close out and follow-up.
  • Reviewing and approving process, assay, and other validation protocols and reports as applicable.
  • Preparing and reviewing applicable sections of regulatory submissions.
  • Preparing and reviewing applicable sections of the Annual Product Reviews.

Skills and Requirements:

  • A BA/BS or Master's in any Life Science discipline.
  • At least 8 years in GxP Drug Manufacturing industry.
  • Able to handle multiple tasks concurrently and in a timely fashion.
  • Good interpersonal skills, including communication, persuasion, and leadership.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • 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 call Kevin Cassini on +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.