Job Title: Spec 3, Quality Auditing / Systems
Duration : 12 Months
Location : Warwick Rhode Island 02886

Job Description:

MS Documentation Remediation Specialist will provide dedicated support for Quality Management System (QMS) documentation review, remediation, harmonization, and cleanup activities for the Client Surgery business unit. This role will focus on assessing controlled documents for compliance, consistency, clarity, and alignment with applicable regulatory requirements and internal standards.

The successful candidate will possess hands-on experience working within both pharmaceutical GMP, medical device and combination product quality systems and be capable of independently reviewing procedures, work instructions, forms, quality manuals, and supporting records to identify gaps, redundancies, inconsistencies, and opportunities for simplification and standardization.

The contractor will be expected to:

Review and assess assigned QMS documents.
Document findings and recommended actions.
Update and revise documents as directed.
Maintain remediation trackers and metrics.
Support closure of documentation-related remediation activities.

Responsibility:
1. QMS Documentation Review
Conduct comprehensive reviews of controlled QMS documentation, including:
Policies | Quality Manuals | SOPs | Work Instructions | Forms and Templates | Quality Plans
Validation-related procedures
Complaint, CAPA, Audit, Risk Management, and Change Control procedures
2. Document Reconciliation and Cleanup
Perform document reconciliation and cleanup activities to:
Eliminate duplicate or obsolete documents
Correct formatting inconsistencies
Standardize terminology and definitions
Improve document structure and usability
Align references and hyperlinks
3. Regulatory Compliance Assessment
Assess documentation against applicable requirements, including:
21 CFR Parts 210, 211, and 820/QMSR
21 CFR Part 4 (Combination Products)
ISO 13485
ICH Q10
EU MDR and other applicable global regulations
Identify compliance gaps, conflicting requirements, and areas requiring revision.
4. QMS Harmonization
Support QMS harmonization initiatives by comparing legacy and future-state procedures and recommending streamlined approaches.
5. Cross-Functional Collaboration
Collaborate with Quality, Regulatory Affairs, Operations, Engineering, Manufacturing, Supply Chain, R&D, and other SMEs to resolve documentation issues.
6. Documentation Tracking and Reporting
Maintain document review trackers and provide regular project status updates.
7. Electronic Document Management
Support migration of documentation into electronic document management systems (eDMS) as required.
8. Audit Readiness and Inspection Preparation
Assist with audit readiness and inspection preparation activities by ensuring documentation is complete, current, and inspection-defensible.
Participate in remediation projects associated with regulatory observations, internal audits, quality improvement initiatives, or QMS transformation efforts.
9. Global Regulatory Compliance
Ensure compliance with global regulations specific to the products managed and sold by the Surgery Business Unit are incorporated into the overall QMS structure, alternatively, are accounted for in the business unit QMS 

Knowledge and Skills
Strong working knowledge of:
cGMP requirements
Quality System Regulation (QMSR) | ISO 13485 | ICH Q10
Risk Management principles
Excellent technical writing, editing, and document review skills.
Strong attention to detail and ability to identify documentation inconsistencies and compliance gaps.
Ability to interpret regulatory requirements and translate them into practical quality system expectations.
Ability to understand Corporate, Business Unit, and Plant Quality Systems and implement systemic changes to enhance product quality and improve business efficiency at the Business Unit and Plant levels.
 

 

 
 
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 $44.00/hr - $48.00/hr.