Batch Record Issuing Specialist

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.

Acting as an integral part of the Batch Record Issuing (BRI) department, Level 3 Specialists train and mentor fellow BRI Specialists, demonstrate a basic comprehension of cGMPs, and proficiently plan workloads for batch record issuance. Working mostly independently, Level 3 Specialists are involved with scheduling, interdepartmental communication and organizing and distributing issued batch records. While displaying strong communication and organizational skills, the Specialists become leaders among their teammates as well as a reliable resource for Lonza as a whole.

Key responsibilities:

  • Independently issue batch records, both electronically and paper, scheduled and ad hoc; ensuring that manufacturing receives the correct issue of the document at the required time
  • Collaborate with associated departments to ensure on-time delivery of batch records
  • Maintain the disaster recovery system for batch records; determine if any already-issued batch records need to be re-issued or recalled
  • Review and process subsequent issues from previous shifts accordingly into the appropriate systems (e.g. Accutrac and Bill of Documents)
  • Review and file issue lists
  • Assess change controls.  Review, attach, and annotate batch records with associated change controls; assist in in managing compliant change management system
  • Support deviation investigations where required
  • Responsible for training and mentoring other members of Batch Record Issuing, QA and Manufacturing
  • Perform file audits, procure BRI related supplies

Key requirements:

  • High school diploma or equivalent; 4-year college degree- Preferred area of study: Science-based field
  • Intermediate years’ experience in a regulated environment with experience in a busy operation, meeting tight deadlines
  • QA or Manufacturing experience preferred
  • Process (technical) or scheduling knowledge preferred
  • Displays solid understanding of the technical process and workflow of daily QA job activities
  • Strong attention to detail
  • Organized
  • Strong verbal and writing skills
  • Independent worker, able to work effectively in a team environment
  • Proficient in MS Word applications
  • Customer-focused
  • Positive attitude, strong communication skills verbal and written
  • Good interpersonal skills
  • Adaptable/flexible to support Manufacturing needs
  • Excellent time management skills
  • Is aware of the safety expectations and applies them in the execution of job duties

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if it is not achieved ethically.

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: R28739