QA Documentation Specialist - Portsmouth, NH

Job Title: QA Specialist III

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.

Key Accountabilities:

• 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 Client’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 Client DI policies, guidelines and procedures
• Apply Data Integrity principles in all aspects of work, in compliance with Client DI policies, guidelines and procedures.
• Perform other duties as assigned.

Education:

• Bachelor of Science(Science related discipline or relevant experience in the field)

Qualifications:

• Extensive experience in quality assurance and validation processes.
• Strong understanding of Client’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