QA COMPLIANCE SPECIALIST

lonza
US - New Hampshire - Stratham
November 5, 2024
IT

Job Summary

Today, Lonza is one of the world's largest healthcare manufacturing organizations operating across five continents. This role is to serve as the Lonza Subject Matter Expert on QMS records and ensuring compliance to GMP documents. The incumbent is expected to be capable of identifying as well as resolving Quality issues. 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 insight 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

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.

• 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.

• Able to assess events to determine possible impact to regulatory and operational compliance.

• 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).

• Attend meetings prepared to speak to any project/change and identify quality requirements and defining path forward in relation to Documentation revision.

• Agreements made within the meetings may have larger impact to the site. Responsible for consulting with QA Management.

• Lead departmental projects defining project plan, scope, and deliverables as assigned (e.g. PQR reports, interim data analysis, risk assessments, etc.).

• Manage and track department Key Performance Indicator Quality metrics and attend other meetings - representing the QA Compliance department.

• Mentor and train other QA Compliance Specialists.

• Assumes leadership role in absence of Manager.

Qualifications

• Bachelors Degree is required

• 5-10 years of Quality Assurance required

Read the full job description and apply online on the recuiter's web-site

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