QA Documentation Specialist 2

Creative Solutions Services, LLC; Portsmouth (NH); On-site; USD 90,000 - 120,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a QA Specialist III to review and approve GMP documentation across Manufacturing, Validation, MES, and Quality Control. This role serves as SME for QA document review of equipment/instrumentation, validation maintenance, and computer/analytical systems.

You will interact with QA Specialists, PMs, and management, ensuring superior internal customer service and escalating items as required.

Qualifications

• Bachelor of Science.
• Advanced - 5-10 years in quality assurance and validation processes.
• Strong understanding of CSV validation guidelines, templates, and SOPs.

Responsibilities

• Review and approve documents (SOPs, work instructions, eBR, forms) in the Document Management System.
• Review non-DMS documents (CMMS forms, instrument data sheets, memos).
• Follow documentation revision procedures and escalate issues as needed.
• Participate in routine meetings and data queries; compile reports.
• Apply Data Integrity principles in all aspects of work per Lonza DI policies.
• Assist with quality systems and regulatory compliance.

Skills

GMP knowledge

Quality assurance

Validation processes

Project management

Data integrity

Education

Bachelor of Science

Tools

LIMS

TrackWise

SAP

Syncade

Job description

Summary:

• The QA Specialist primary responsibility is the review and approval GMP documentation associated with Site operations, to include Manufacturing, Validation, MES, and Quality Control. This role is to serve as a Subject Matter Expert (SME) for QA document review relevant to Equipment/Instrumentation, Validation Maintenance, and relevant Computer and Analytical Systems as well as assist with certain customer specific documentation. They interact with other QA Specialists, QA PMs and Management supporting Site operations. This role is capable of identifying, defending, and resolving quality issues referencing appropriate supporting procedural documentation with supervision. The QA Specialist III interacts directly with internal customers concerning documentation and projects. The QA Specialist will ensure superior customer service to internal customers and escalating items as required.

Responsibilities:

• Utilizing an identified standard, independently review and approve in a Document Management System initial version and revised documents such as SOPs, Work Instructions, eBR and Automation Documentation, Forms & Checklists, Scanned Documents and others as needed independently. QA Specialist III will also review and approve electronic and/or paper Validation / Qualification documents such as Protocols & Summary Reports for Equipment/Instrumentation, Validation Maintenance, and relevant Computer and Analytical Systems.
• Review and approve non-DMS documents (QA Monthly Preventative Maintenance, Engineering Preventative Maintenance documents, CMMS Forms, Instrumental 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.
• Follow associated documentation revision and review procedures and issues / concerns escalated to senior QA Specialist or management for mentoring through process while working with internal customers to gain information required to resolving those issues/concerns.
• Participate in routine meetings, data queries and report section compilation as assigned by management.
• Apply Data Integrity principles in all aspects of work, in compliance with Lonza DI policies, guidelines and procedures.
• Apply Data Integrity principles in all aspects of work, in compliance with Lonza DI policies, guidelines and procedures.
• Perform other duties as assigned.

Education:

• Bachelor of Science.

Work Experience:

• Advanced - 5-10 years.
• Extensive experience in quality assurance and validation processes.
• Strong understanding of Lonza's CSV validation guidelines, templates, and SOPs.
• Excellent project management skills to lead and coordinate local QA-PM activities.
• Effective communication and collaboration skills to work with various stakeholders.
• Proficiency in using LIMS or similar systems and familiarity with quality standards and regulatory requirements.

Skills:

• Strong understanding and 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, and 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 situation that require escalation with / without guidance.
• Advanced technical knowledge of Quality control and manufacturing operations.
• Working knowledge and experience with Quality Systems including deviations, change controls, CAPAs, OTNs, deviations; both the system (TrackWise) and the practical applications in operations.
• Knowledgeable in process, equipment, cleaning, and computer system validations to the extent of being able to effectively review and approve protocols and reports and support implementation of new equipment.
• Demonstrated ability to manage medium to large sized projects within required timeframes.
• Demonstrate ability for effective Planning, Organizing and Controlling competency.
• Demonstrate sound decision making.
• Ability to work inter-departmentally and with customers.
• Demonstrates role model behaviors for GMP and Safety behaviors.