QA Documentation Specialist 2

Job Title: QA Specialist III
ID: 26-04286
Location: Portsmouth, NH
Duration: 08 Months

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 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 policies, guidelines and procedures

• Education: Bachelor of Science

Area

• Quality Assurance, Biotech / Pharma / GMP Environment

Work Experience

• Advanced - 5-10 years

Skills

• What analytical capabilities or niche skillset does this role require
• 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

Contact:
Sunny Rajput | sunny.r@sunrisesys.com | URL: www.sunrisesys.com