Senior QA Compliance Specialist

United States, Portsmouth (New Hampshire)

Today, Lonza is a global leader in life sciences operating across three continents. 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 Senior QA Compliance Specialist primary responsibility is the closeout of all documentation prior to the release of Production Batches. Documentation includes manufacturing batch records and ancillary documentation such as Lot Genealogy Reports, Quality Control Assays used in the production of cell therapy products at the Lonza Portsmouth Facility. Participation in the Daily Lot Release meetings is also required. Senior QA Compliance Specialist makes decisions regarding simple and some complex issues that arise during review of records and assists junior staff with this type of decision-making. Escalation to senior members of the Quality Assurance Operations team is employed for some complex issues. Senior QA Compliance Specialist demonstrates understanding of Quality Systems, Manufacturing practices, Good Documentation Practices, Regulatory expectations as well as professional skills of effective communication and listening. Develops leadership skills such as coaching and feedback. Additional process improvement projects may be assigned for independent work. Trains junior staff for record review.

Key responsibilities:

  • Independent Review and Closure of Manufacturing Batch Records and ancillary documentation to support the release of cell therapy products.
  • Review will be performed independently with minimal direction for the review process.
  • Participate in all daily release meetings.
  • Simple and complex issues should be managed at this level. Fact-finding and interpretation of the complex issues will be independent in most cases. Some complex issues will be escalated when dealing with multiple groups and unclear process issues that have not been previously encountered.
  • Participate in routine meetings as assigned by supervision
  • Trains staff as required
  • Demonstrates skill set to include: understanding of Quality Systems, Manufacturing, Good Documentation Practices, communication and listening
  • Support Daily Management System and departmental tasks as assigned

Key requirements:

  • Education Bachelor’s Degree or Associates Degree with equivalent experience
  • Preferred area of study: Science or Engineering background preferred
  • Experience Intermediate to advanced years in GMP environment preferred
  • Biopharmaceutical manufacturing background is preferred
  • Knowledge General knowledge of Good Manufacturing Practices (cGMP) required. Knowledge of Microsoft Office Tools
  • (Word, Excel, Outlook)
  • Skills Attention to Detail is required. Critical thinking in a Good Manufacturing Practices (GMP) environment. Ability to visualize concepts and turn them into project plans with support of supervision. Skills in systems such as TrackWise, Systems, Applications and Products (SAP) are preferred.
  • Motivated individual who has an attention to detail. Can work independently with minimal guidance from supervision. Adaptable to changing priorities and reprioritization of workload. Works effectively individually and with teams with direction as required.

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: R33285