QA Documentation Specialist 2
Portsmouth, NH
Date Posted:26-Aug-2026
Work Type:On-Site
Job Number:496160
Job Description
Position Title: QA Documentation Specialist/QA Specialist III
Work Location: Portsmouth NH 03801
Assignment Duration: 8 Months
Work Schedule: Regular Office Hours
Work Arrangement: Onsite
Position 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 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
• Apply Data Integrity principles in all aspects of work, in compliance with policies, guidelines and procedures.
• Perform other duties as assigned.
Qualification & Experience:
• Extensive experience in quality assurance and validation processes.
• Strong understanding of 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.
• 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
Education:
Bachelor of Science in Science related discipline or relevant experience in the field
Work Experience:
Quality Assurance, Biotech / Pharma / GMP Environment – Advanced - 5-10 years
Language: English preferred – Ability Level 2 - Business Fluent
Supervision: Supervision – The incumbent performs a variety of routine work within established policies and procedures, and receives detailed instructions on new projects and assignments.
Working Conditions & Physical Demands (If Applicable):
Safety: Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site.
Quality Responsibility: Adherence to cGMPs is required at all times during the manufacture of APIs. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.
Environmental Demands: The normal working environment is: Office Setting
Mental Demands: Full comprehension of process flow and is able to identify factors which influence the process. Must be able to read and follow defined SOPs and policies. Works independently on basic manufacturing tasks, identifies, communicates and resolves non-routine events, and reviews more complex decisions with Supervisors. Must be able to use automated process equipment and tools.
Additional Information (If Applicable):
Key Stakeholders: Quality Control, global gLIMS Team, Manufacturing Operations
Quality: Adherence to cGMP is required at all times during the manufacture and release of APIs. All personnel own the quality of what they deliver and are responsible for notifying management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and relevant actions.
Safety: Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site. Employee owns their own safety, the safety of their team and the safety of others.
Work Location: Portsmouth NH 03801
Assignment Duration: 8 Months
Work Schedule: Regular Office Hours
Work Arrangement: Onsite
Position 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 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
• Apply Data Integrity principles in all aspects of work, in compliance with policies, guidelines and procedures.
• Perform other duties as assigned.
Qualification & Experience:
• Extensive experience in quality assurance and validation processes.
• Strong understanding of 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.
• 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
Education:
Bachelor of Science in Science related discipline or relevant experience in the field
Work Experience:
Quality Assurance, Biotech / Pharma / GMP Environment – Advanced - 5-10 years
Language: English preferred – Ability Level 2 - Business Fluent
Supervision: Supervision – The incumbent performs a variety of routine work within established policies and procedures, and receives detailed instructions on new projects and assignments.
Working Conditions & Physical Demands (If Applicable):
Safety: Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site.
Quality Responsibility: Adherence to cGMPs is required at all times during the manufacture of APIs. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.
Environmental Demands: The normal working environment is: Office Setting
Mental Demands: Full comprehension of process flow and is able to identify factors which influence the process. Must be able to read and follow defined SOPs and policies. Works independently on basic manufacturing tasks, identifies, communicates and resolves non-routine events, and reviews more complex decisions with Supervisors. Must be able to use automated process equipment and tools.
Additional Information (If Applicable):
Key Stakeholders: Quality Control, global gLIMS Team, Manufacturing Operations
Quality: Adherence to cGMP is required at all times during the manufacture and release of APIs. All personnel own the quality of what they deliver and are responsible for notifying management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and relevant actions.
Safety: Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site. Employee owns their own safety, the safety of their team and the safety of others.
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's pay range is $70.94/hr – $72.41/hr.