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Temporary Quality Assurance (QA) Raw Materials Specialist at US02 Lonza Biologics Inc.

Posted in Science 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: Portsmouth, New Hampshire





Job Description:

 

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The Temporary Raw Materials Quality Assurance Specialist interacts directly with Lonza’s internal customers for disposition of materials.  Using a solid understanding of cGMP documentation, the Specialist will review material release documentation as well as other ancillary attachments such as vendor technical documentation, certificate of analysis/compliance and confirmatory test results, in order to ensure the timely release of raw material for production.  They will be able to resolve simple issues and provide escalation of more complex issues to Lead Specialists or management for resolution and/or improvements.  The Specialist will also be expected to perform all associated SAP transactions as part of the release as well as other Quality functions within Systems, Applications & Products (SAP).

Key responsibilities:


  • Interact with internal customers for disposition of materials.

  • Reviewing and revising various material specific documents, as needed.

  • Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries.  Must comply with safety policies of the company and site. 

  • Adherence to Good Manufacturing Practices (cGMPs) is required at all times during the manufacture of Active Pharmaceutical Ingredients (APIs).  All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious Good Manufacturing Practices (GMP) deficiencies, process deviations, product defects and related actions.

  • High output while multi-tasking required

Key requirements:


  • Associates Degree or equivalent experience.  Preferred area of study:  Scientific related field.

  • Entry level years in Good Manufacturing Practice (GMP) environment preferred.  Biotechnology manufacturing background is preferred.

  • Knowledge of GMP’s and regulations

  • Experience with Trackwise, Systems, Applications & Products (SAP), Syncade and Microsoft Suite preferred

  • Self-starter, excellent written and verbal communicator at all levels, able to tolerate challenging workloads and changing priorities, attention to detail, works effectively individually and with teams

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.