The Quality Compliance Specialist Level IV’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. As the highest 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. Role will also include mentoring less experienced Compliance Specialists as well as internal customers

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.
• Able to review document changes determining 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 and interim data analysis).

Qualifications:

-Bachelors Degree

-5-10 years of experience

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

• 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).
• 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.