Overview
QA Specialist II Jobs in Houston, TX at VIVOS Professional Services, LLC
Title: QA Specialist II
Company: VIVOS Professional Services, LLC
Location: Houston, TX
Job Title: QA Specialist II – Quality Operations
Location: Houston, TX (On-site)
Pay Range: $30-51/hr on W2
Job Summary
The QA Specialist II – Quality Operations is responsible for representing the Quality Assurance function to ensure compliance with cGMP and regulatory standards. This role supports manufacturing operations and related functions by reviewing quality documentation, supporting investigations, and ensuring adherence to quality systems. The position plays a key role in maintaining product quality, regulatory compliance, and operational excellence.
Key Responsibilities
- Ensure compliance with ISO, GMP, and regulatory quality system requirements.
- Provide oversight for CAPA processes and manage minor deviations.
- Perform QA walkthroughs and collaborate with manufacturing and support teams to resolve quality issues.
- Support on-the-floor QA activities within manufacturing operations.
- Review Master Batch Records (MBRs) and supporting documentation for batch disposition.
- Approve GMP documentation across Quality Control, Manufacturing, and supporting departments.
- Assist in investigations using structured problem-solving tools.
- Support change controls and corrective action implementation.
- Track and maintain quality records in compliance with cGMP standards.
- Perform additional duties as assigned.
Key Stakeholders
- Facilities & Engineering
- Manufacturing
- Quality Control
Supervision
- Operates under general supervision with minimal day-to-day oversight.
- Receives guidance on new assignments and projects.
Qualifications
Education
- Bachelor’s Degree in Life Sciences, Engineering, or related field
Experience
- 0–4 years of experience in GMP-regulated pharmaceutical or biologics industry
- Experience in biopharmaceutical manufacturing environments
- Knowledge of GMP and GDP practices
- Familiarity with equipment, facility, and utility validation
Skills
- Strong understanding of regulatory requirements (US, EU, and global standards)
- Experience with deviation investigations and CAPA processes
- Knowledge of validation activities
- Strong documentation and technical writing skills
- Analytical and problem-solving abilities
Core Competencies
- Agility: Ability to adapt to changing priorities and support cross-functional needs
- Business Acumen: Effectively communicate risks, timelines, and project status
- Collaboration: Work effectively with cross-functional teams under deadlines
- Customer Focus: Deliver clear communication and responsive support
- Driving Results: Proactively identify gaps and implement improvements
- Leadership: Demonstrate decision-making ability and conflict resolution skills
Responsibilities Overview
- People Management: No direct or indirect reports
- Budget: Ensure activities are within defined budget
- Quality: Ensure compliance with quality standards supporting manufacturing
- Safety: Promote and adhere to workplace safety standards
Work Environment & Conditions
- Office-based with regular interaction on the manufacturing floor
- Low travel requirement (<10%)
- Regular business hours
Physical Requirements
- Ability to perform activities such as walking, sitting, standing, and occasional lifting (up to 50 lbs)
- Capability to work in both office and production environments, including gowning when required
Additional Requirements
- Strong analytical and critical thinking skills
- Ability to manage stakeholder interactions and resolve complex issues professionally
- Commitment to maintaining cGMP compliance and quality standards
