Senior Quality Assurance Compliance Specialist

6 days ago

Portsmouth, New Hampshire, United States Lonza Full time

Job Summary:

The Quality Compliance Specialist Level IV is a critical role within Lonza, responsible for ensuring the accuracy and compliance of documents across the organization. This position requires a high level of expertise in quality assurance and compliance, with a strong understanding of regulatory requirements and industry standards.

Key Responsibilities:

  • Review and approve documents in a Document Management System, including SOPs, Master Batch Records, Work Instructions, Test Methods, Specifications, Forms & Checklists, Scanned Documents, and others as needed.
  • 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, including 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.
  • Determine the possible impact of document changes on regulatory and operational compliance.
  • Document review observations, including suggested edits/comments, if applicable.
  • Follow Lonza's documentation review procedures and ensure changes are justified appropriately and accurately reflected in the document.
  • Partner with internal customers as part of Documentation Changes & Review, serving as the Quality Subject Matter Expert.
  • Support departmental projects, such as PQR reports and interim data analysis.
  • Attend meetings prepared to speak to any project/change and identify quality requirements and define the path forward in relation to Documentation revision. Agreements made within the meetings may have a larger impact on the site. Responsible for consulting with QA Management.
  • Lead departmental projects, defining project plans, scope, and deliverables as assigned.

Qualifications:

  • Bachelor's Degree
  • 5-10 years of experience
  • Knowledge of GMP's and regulations preferred (e.g. ICH Q7-Q11, CFR 210, 211, 820, etc.)
  • Superior written and verbal communication skills, enabling self to be understood at all levels. Experience with Microsoft Office Tools (e.g. Word, Excel, Outlook, & PowerPoint).
  • Experience in enterprise systems, such as DMS, LIMS, TrackWise, SAP, Syncade, etc.
  • 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.

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