Pay Rate Low: 33 | Pay Rate High: 45

Quality Assurance Specialist II

Location: Houston, TX (Onsite)
Duration: 9–12+ month contract assignment
Pay Rate: $33–$45/hr (based on experience)
Industry: Life Sciences / Medical Device / Biotech

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Overview

A leading life sciences organization is seeking a Quality Assurance Specialist II to support and enhance core Quality Management System (QMS) processes. This contract role will play a key part in maintaining quality compliance, driving continuous improvement initiatives, and supporting cross-functional quality programs across operations.

This individual will work closely with Quality leadership and internal stakeholders to strengthen quality systems, improve compliance readiness, and support risk mitigation across the organization.

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Key Responsibilities

• Provide Quality oversight and support for manufacturing and operational activities

• Review and approve production lots to ensure compliance with specifications and procedures

• Track, trend, and analyze quality data to identify risks and improvement opportunities

• Drive continuous improvement through metrics, investigations, and process monitoring

• Support and lead Quality System processes including deviations, CAPA, and change control

• Maintain and improve Document Control processes within an electronic QMS

• Support supplier qualification and vendor quality programs

• Participate in validation review activities (equipment, systems, process changes)

• Assist with audit readiness, hosting, and remediation activities

• Generate quality metrics and communicate compliance risks to stakeholders

• Develop and deliver QMS training across the organization

• Mentor junior team members and help foster a strong culture of quality

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Quality Systems Ownership Areas

• Production lot release and record review

• Deviations, nonconformances, and CAPA investigations

• Change management and controlled implementation

• Supplier qualification and quality agreements

• Validation and qualification review

• Document control and SOP lifecycle management

• Quality metrics trending and reporting

• Audit preparation and compliance tracking

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Qualifications

Education:

• Bachelor’s degree required (Engineering, Biology, Chemistry, Statistics, or related field preferred)
  OR equivalent combination of education and 6–8+ years of relevant experience

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Experience & Skills

• Strong working knowledge of Quality Management Systems within regulated environments

• Experience supporting FDA and/or ISO-regulated industries

• Hands-on experience with deviations, CAPA, change control, and investigations

• Experience with document control and electronic QMS platforms (e.g., MasterControl preferred)

• Knowledge of statistical analysis tools (Minitab, R, etc.) preferred

• Strong technical writing and investigation skills

• Familiarity with biological or analytical lab environments is a plus

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Regulatory Experience (Preferred)

Experience supporting one or more of the following:

• FDA (21 CFR 820, cGMP, cGTP)

• ISO 13485, ISO 9001

• ISO 15189 / ISO 17025

• Medical device, diagnostics, or life sciences manufacturing
  
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