Quality Specialist – I (Assistant)

  • Type: VMS
  • Job #38612

Seeking a Quality Specialist for our client – a leading global pharmaceutical company who specializes in the development and manufacturing a variety of well-known pharmaceutical drugs, vaccines and animal-health products.

*1 year contract role. Hybrid, onsite 2-3x a week.


  • Direct support for batch documentation review ensuring our clinical supplies are in compliance with current GMP regulations and regulatory filing submissions.
  • Evaluation and disposition of clinical supply materials with the assurance that the materials were produced in conformance to all applicable.
  • Coordinate and/or support the preparation of procedures, processes and quality improvements.
  • Assists in the coordination of significant quality events including fact-finding, investigation support, and coordination of clinical quarantine and recovery actions.
  • Collaboration across Integrated Process Team (IPT) functional and business areas to ensure robust processing, continuous improvement and cross-functional team building.
  • Providing on-the-floor support of operational and technical issues; providing immediate responses on the shop floor to deviations and potential deviations.
  • Completing projects to improve the performance of our processes, including continuous process improvements, investigation Corrective/Preventative Actions (CAPAs), and value capture projects that seek to improve yield, reduce cost, or lower our processing cycle times.
  • Managing investigation, change request and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans, when possible.
  • Actively using and championing the use of Lean Six Sigma (LSS) and our Company’s Production System (PS) tools, both in problem solving and day-to-day operational activities.


  • Minimum of two years’ post-degree experience in the Pharmaceutical or equivalent industry (GMP related field) including Technical, Engineering, Quality or Operations.
  • In-depth working knowledge of current GMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.
  • Basic understanding of the use and maintenance for Microsoft (MS) applications (such as MS Excel, Outlook, and/or MS Access).
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Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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