Remote :: QMS specialist

Job Title: Quality Specialist Position
Location: Remote
Duration: 6 Months
Interview Mode: Video


Job Description:


Please send resumes with candidates'' current location, rate, and contact information to help expedite the process.

Work schedule (days & time): M-F 8:00 am-4:30 pm CST


Quality Specialist
Fully Remote
Position Summary
The Quality Specialist position is REMOTE, M-F 8 am-4:30 pm CST. They are responsible for supporting the Quality Management System (QMS) with a strong focus on supplier quality, customer and supplier engagement, and controlled substances compliance within a regulated medical distribution environment.

This role serves as a key contributor to:
• Customer and supplier quality questionnaire completion
• Quality Agreement and contract review/management
• Development and maintenance of SOPs for controlled substance (Rx) processes and QMS operations
The role supports and maintains processes in alignment with ISO 13485 Quality Management System requirements, including risk-based thinking, supplier controls, and documented process governance.
The position requires a high level of regulatory knowledge, attention to detail, cross-functional collaboration, and the ability to ensure that all externally communicated quality information accurately reflects the organization''s compliance posture.

Key Responsibilities
1. Customer & Supplier Quality Engagement
• Lead and coordinate completion of customer and supplier quality questionnaires, supporting:
o Supplier qualification and onboarding
o Customer due diligence and audits
o Supplier file maintenance
• Ensure all responses are:
o Standardized, accurate, complete, and aligned with current QMS procedures and operational practices
o Supported by documented evidence and approved quality statements
• Collaborate cross-functionally (Quality, Regulatory, Operations, Legal, Security, Category Management) to gather required inputs
• Review responses for:
o Consistency with internal policies and prior submissions
o Alignment with DEA, FDA, and applicable regulatory requirements
• Maintain controlled records of completed questionnaires and supporting documentation
• Identify gaps, inconsistencies, or risk areas revealed through questionnaire completion and escalate as appropriate

2. Quality Agreements & Contract Review
• Review and support negotiation of:
o Customer Quality Agreements
o Supplier Quality Agreements
o Controlled substance-related contracts and service agreements
• Ensure agreements clearly define:
o Roles and responsibilities (quality, regulatory, security)
o Handling, storage, and distribution requirements for controlled substances
o Deviation, complaint, and recall responsibilities
o Audit rights and compliance expectations
• Verify alignment with:
o DEA regulations (21 CFR Part 1300–1317)
o FDA requirements (21 CFR Part 211, as applicable)
o Internal QMS procedures and Operations practices
• Partner with Legal and Compliance teams to ensure contractual language mitigates diversion, compliance, and supply chain risks
• Track agreement execution, periodic review, and updates

3. Controlled Substances (Rx) Process Development
• Develop and maintain SOPs governing:
o Receipt, storage, distribution, and returns of controlled substances
o Inventory control, reconciliation, and cycle counting
o Loss/theft reporting and escalation processes
• Ensure SOPs incorporate:
o Physical security and access controls (restricted access, vaults, cages)
o Monitoring and surveillance expectations
o Chain-of-custody and traceability requirements
• Align processes with DEA regulatory requirements and internal security programs
• Support implementation, training, and effectiveness monitoring of controlled substance processes

4. QMS SOP Development & Continuous Improvement
• Author, revise, and maintain QMS procedures, including:
o Supplier Quality processes
o Document control and training processes
• Ensure SOPs are:
o Clear, compliant, and aligned with GDP, ISO 13485 principles, and internal standards
o Written in an audit-ready, controlled format
• Support periodic review cycles and ensure procedures remain current with evolving regulations and business needs
• Identify process improvement opportunities and drive standardization across functions


5. Regulatory Compliance & QMS Support
• Maintain working knowledge of:
o DEA controlled substance regulations (21 CFR Part 1300–1317)
o FDA Good Distribution Practices / 21 CFR Part 211 (as applicable)
o DSCSA traceability requirements
o ISO 13485 principles and requirements including:
Clause 4: Quality Management System
Clause 6: Resource Management (training and competency)
Clause 7: Product Realization / Supplier Controls
Clause 8: Measurement, Analysis, and Improvement
• Ensure QMS processes align with:
o Documented procedures and record control requirements (ISO 13485 Clause 4.2)
o Training and competency requirements (Clause 6.2)
• Support implementation of a risk-based approach in quality processes, including supplier evaluation, questionnaire review, and contract assessment.
• Support QMS activities including:
o Document control
o Training compliance

6. Documentation & Record Integrity (ALCOA+)
• Ensure all records and documentation meet ALCOA+ principles
• Maintain complete, accurate, and retrievable records for:
o
o Agreements and contracts
o SOPs and controlled documents
• Ensure compliance with record retention and document control requirements

Minimum Qualifications
• Bachelor''s degree in a scientific, healthcare, or quality-related field (or equivalent experience)
• 3–5+ years of experience in:
o Quality, compliance, or regulated distribution/warehouse environment
• Experience with:
o Supplier quality processes
o Controlled substances
• Working knowledge of:
o DEA and FDA regulatory requirements
• Strong technical writing, documentation, and audit readiness skills

Preferred Qualifications
• Experience supporting:
o Quality Agreement development and negotiation
o Customer and supplier audit processes
• Experience with DEA inspections
• Certification (ASQ CQE, CQA, or equivalent)
• Experience with MasterControl or similar eQMS systems
• Background in pharmaceutical, medical device, or healthcare distribution
This role requires strict adherence to regulatory, quality, and security requirements associated with controlled substances. The individual must demonstrate strong judgment, integrity, and the ability to identify, assess, and escalate compliance risks across supplier, customer, and internal processes.