QA Principal Operations Specialist- Cell Therapy- Night Shift

United States, Portsmouth (New Hampshire)

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 Cell Therapy Quality Assurance Operations Specialist must have significant quality experience and be able to provide oversight and guidance for multiple concurrent cell Therapy programs.  The individual who fills this role will be a strong partner with the Cell Therapy Operations group, customers, and the site Quality Systems group.  Key functions include on-the-floor Quality Assurance support, batch record review, deviation review and approval, change control, and review of procedures and Master Batch Records.  Prior experience in cell therapy and/or aseptic processing is desired, but not essential.  A strong foundation in application of GMPs in a drug substance or drug product manufacturing environment is critical, as is an ability to quickly assess facts and make the appropriate decision when process/product quality may be impacted.  As Cell Therapy is a relatively new field, the incumbent must be able to appropriately apply Good Manufacturing Practices (GMPs) for biologics, drugs and medical Human Cell & Tissue Products (HCTP) to situations for which precedents have not been set.

this is a 7 pm- 7 am shift, Monday - Thursday.   This position is considered essential and requires Quality Assurance Operations presence deemed critical, possibly including Holidays and during site closure.

Key responsibilities:

  • Spends time in manufacturing areas observing operations to ensure compliance with procedures, review executed batch records, and provide coaching and feedback for Good Manufacturing Practices (GMP) and documentation behaviors. A fundamental knowledge of the processes performed for the manufacture of cell therapy products is required, as well as an understanding of the requirements and controls for aseptic processing, including small-scale aseptic drug product manufacture.  Conducts training sessions as appropriate to support Good Manufacturing Practices (GMP) work-habits and knowledge.  Provides guidance to Manufacturing and other groups for routine and non-routine issues and is able to independently deal with complex issues.  Responsible for timely review of executed batch records and relevant supporting documentation for release of batches.
  • Represents Quality Assurance for internal and external project and team meetings.  Provides quality strategies to ensure compliance with regulatory requirements and to minimize quality issues.  Interfaces with customers and internal groups for resolution of quality issues.  Has decision-making authority for all but the most complex of quality issues. 
  • Responsible for facilitating and reviewing/approving change controls and deviation investigations, and for ensuring that change controls, investigations and Corrective and Preventative Actions (CAPA) meet regulatory requirements.  Interfaces with customers for review and approval of change controls and deviation investigations.  Maximizes the efficiency and quality of change control and investigation packages such that project and delivery timelines are met                                   
  • Reviews and approves Master Batch Records, Standard Operating Procedures (SOPs), study protocols and summary reports, forms, etc. relevant to manufacture of cell therapy products.  Reviews to ensure that procedural requirements for generation, review, approval and revision of documents are adhered to, with subject matter experts being responsible for technical content for all documents other than those documents specific to quality assurance activities.
  • With the site Inspection and Audit management group, interfaces with customers and regulatory agencies in the management and response to internal audits and regulatory inspections.
  • Other duties to support cell therapy quality operations

Key requirements:

  • Bachelors Degree with preferred area of study in Life Sciences
  • Typically intermediate to advanced years of experience in Quality Assurance Operations in a position with significant responsibilities and a demonstrated history of independent decision-making : or Advanced plus years in a Good Manufacturing Practices (GMP) environment inclusive of a diversified Quality background/experience.
  • This position is responsible for the widest range of decision-making, from simple to complex decisions.  The incumbent must have the ability to independently assess quality issues and triage the majority of issues but also escalate to Senior management when appropriate.
  • Has solid understanding of cGMP and ICH guidelines and requirements
  • Must possess a basic working knowledge and understanding of critical process steps and parameters, including cell culture and exposure to aseptic processing
  • Understands the concept of product clearance through process changeover
  • Knows the concept of deviation management and documentation
  • Understands the TrackWise, Systems, Applications & Products (SAP), Laboratory Information Management System (LIMS), Syncade and Microsoft Office systems
  • Is able to identify and act on situations which require escalation; Can recognize an abnormal or potentially impactful event and knows whom to elevate to
  • Superior GMP knowledge - including outstanding understanding of regulatory expectations and trends, including their impact to quality operations.

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.

Reference: R19057