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 support for temporary and permanent change controls, deviations, standalone investigations, CAPAs, and Product Quality Reviews. As a higher level Compliance Specialist, the incumbent will provide superior customer service to internal customers, effectively serving as a role model for others on the team, and suitable as a documentation trainer within the group. In this role, the incumbent will support QA Project Managers with notifying the customer and assuring the customer’s feedback and comments are addressed, verifies that the quality records are complete; that there is sound justification/scientific rationale, that root cause analysis and corrective and preventive action is appropriate and, where applicable, that customer approval is received. This role is to serve as the Lonza Subject Matter Expert for 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. Role will also include mentoring less experienced Compliance Specialists as well as internal customers on Lonza policy, procedures and industry requirements.

Key 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, with minimal direction for review process.

  • Follow Lonza’s documentation review procedures and ensure changes stated are justified appropriately and accurately reflected in document.

  • Follow associated documentation revision and review procedures and issues / concerns escalated to senior Quality Compliance Specialists or management for mentoring through process while working with internal customers to gain information required to resolving those issues/concerns.

  • Participate in interdepartmental projects with specific guidance and instructions.

  • Participate in routine meetings, data queries and report section compilation (e.g. Annual Product Quality Review evaluations) as assigned by management.

  • Continuously develop review skill set which includes: understanding application and relationship of overall Quality System Elements (e.g. Change Control, CAPA, Deviation, Continuous Improvement, etc.) to update of procedures; effective communication; and active listening and conflict resolution.

  • Perform other duties as assigned.

Key requirements:

  • High School Diploma or equivalent, Bachelor’s Degree preferred.

  • Knowledge of GMP’s and regulations preferred (e.g. ICH Q7-Q11, CFR 210, 211, 600-680, 820, etc.).

  • Excellent written and verbal communicator at all levels. Experience with Microsoft Office Tools (e.g. Word, Excel, Outlook, & PowerPoint) preferred.

  • Experience in enterprise systems such as DMS, TrackWise, SAP, Syncade, etc. preferred.

  • Motivated self-starter who has high attention to detail and adoptable to changing priorities and reprioritization of workload.

  • Works effectively individually and within a team environment with direction as required.

  • Presents facts clearly and logically and understands other perspectives.

  • Able to identify and act on situations that require escalation with / without guidance.

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: R38641