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 Quality Compliance Specialist's primary responsibility is the review and approval of initial version and revised electronic and paper documents. This role is to serve as the Lonza Subject Matter Expert for document review throughout the site. The incumbent is expected to be capable of identifying as well as resolving Quality issues within documents for review with appropriate supporting documentation. The Specialist must be able to weigh the risk of the event and look for the efficient yet compliant solution. The incumbent will provide superior customer service to internal customers and effectively serving as a role model for others on the team. This individual may also perform the role of documentation training support. Role may also include mentoring less experienced Compliance Specialists as well as internal customers on Lonza policy, procedures and industry requirements.

They will require general coaching and will be expected to be well-versed with established workflows and the associated policies. 

Responsibilities

  • Utilizing an identified standard, independently review and approve in a Document Management System initial version and revised documents such as SOPs, Master Batch Records, Work Instructions, Test Methods, Specifications, Forms & Checklists, Scanned Documents and others as needed.
  • Specialist will also review and approve electronic and/or paper Validation / Qualification documents such as Protocols & Summary Reports for CIP, SIP Equipment/Instrumentation, Validation Maintenance, Computer Systems & Stability.
  • Review and approve non-DMS documents (QA Monthly Preventative Maintenance, Engineering Preventative Maintenance documents, CMMS Forms, Instrument Data Sheets, Functional Equivalent Memos, DMS Withdrawal Forms, Periodic Review Audit Trail and Misc. Facility Forms), etc.
  • Document review observations such as suggested edits/comments, if applicable.
  • Follow Lonza’s documentation review procedures and ensure changes stated are justified appropriately and accurately reflected in document.
  • Partner with internal customers as part of Documentation Changes & Review serving as the Quality Subject Matter Expert.
  • Support departmental projects (e.g. PQR reports and interim data analysis).
  • Participate in routine meetings as assigned by management or Senior Quality Compliance Specialists.
  • Lead Quality initiatives within group and possible the Quality organization as assigned by management or Senior Quality Compliance Specialists.
  • Mentor and train other QA Compliance Specialists
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, and cGMP regulations
  • Perform other duties as assigned.

Key Requirements:

  • Bachelor’s degree required
  • 5-10 years of GMP compliance experience
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, and cGMP regulations
  • Knowledge of GMP’s and regulations preferred (e.g. ICH Q7-Q11, CFR 210, 211, 600-680, 820, etc.). Seasoned professional who is technically independent and maintains knowledge of Quality Management System elements.
  • Superior written and verbal communicator and enabling self to be understood at all levels.
  • Experience with Microsoft Office Tools (e.g. Word, Excel, Outlook, & PowerPoint) preferred.
  • Experience in enterprise systems such as DMS, LIMS, TrackWise, SAP, Syncade, etc. preferred.
  • Self-motivated and results oriented. Able to tolerate challenging workloads and changing priorities, and exercises composure, pays attention to detail.
  • Works effectively individually and within a team environment.
  • Able to prioritize own time for multiple activities and possibly others in the group.
  • Presents facts clearly and logically and understands other perspectives.
  • Able to identify and act on situations that require escalation to next-level or senior management.
  • Is aware of safety expectations and applies them in the execution of duties.
  • May assume leadership responsibilities in absence of Manager.

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 not achieved ethically.

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: R56065