Quality Manufacturing Specialist (Night Shift)

Highly Competitive
  1. Permanent
  2. Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP)
  3. United States
San Dimas, California
Posting date: 19 Mar 2019

ProClinical is advertising a vacancy for a Quality Manufacturing Specialist position with a global biopharmaceutical company based in California. The organization prides itself a solid commercial portfolio of life-saving drugs within a number of therapy areas, along with its growing pipeline of investigational drugs. This is an exciting opportunity to join a very-patient focused company with 15 marketed products. This is a night shift position.

Job Responsibilities:

  • Providing on-the-floor QA oversight and support to ensure compliance of GMP activities throughout the site.
  • Directly interfacing with Manufacturing, Supply and Distribution, Maintenance, Metrology, and Quality Control employees to immediately address compliance issues and questions in real-time.
  • Ensuring adherence to proper escalation when non-conformances are identifying as outlined per applicable procedures.
  • Serving as a resource for compliance, escalation, and corrections.
  • Ensuring department compliance to procedures, GMP records, and associated forms.
  • Ensuring documentation is recorded in accordance with ALCOA principles.
  • Working with operating entities with guidance from senior colleagues to ensure that inspections, statistical processes, control analyses, and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
  • Assisting with investigations and corrective and preventive actions (CAPA).

Skills and Requirements:

  • A Bachelor of Science in a relevant field.
  • At least 2 years in relevant experience in a GMP environment related field.
  • Demonstrable knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
  • Demonstrable basic knowledge of FDA standards and quality systems.
  • Experience in Biopharmaceutical or Pharmaceutical required.
  • 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 Sherron Howard at +267 435 8600 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.