Quality Assurance Specialist III (Material & Vendor Lead)

ReviveRX; Houston (TX); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking a Quality Assurance Specialist III (Material & Vendor Lead) to ensure compliance with quality systems and manage vendor qualifications. The role involves overseeing material specifications, conducting audits, and supporting quality improvement initiatives. Ideal candidates will have experience in a regulated environment and strong organizational skills.

Qualifications

• Minimum 3 years of experience in a regulated pharmaceutical environment.
• Experience with vendor qualification and quality systems.

Responsibilities

• Lead vendor qualification and requalification processes.
• Manage material specification packets and ensure compliance.
• Support CAPA and RCA investigations.

Skills

Organizational Skills

Analytical Skills

Communication Skills

Education

Bachelor's degree in Life Sciences

Tools

ERP/inventory management systems

Job description

Job Title: Quality Assurance Specialist III (Material & Vendor Lead)

Department: Quality Assurance

Location: Revive Rx Houston Onsite

Reports To: Quality Assurance Manager

Position Summary:

The Quality Assurance Specialist III (Material & Vendor Lead) is a key member of the QA team responsible for supporting and maintaining the quality systems that ensure compliance with internal procedures, regulatory requirements (e.g., USP and State Board of Pharmacy), and industry best practices. This role will perform general QA duties with a lead focus on vendor qualification and requalification of vendor or service provider audits and quality agreements (as applicable). Management of material specification packets, oversight of critical vendor and supplies lists, and materials management activities including quarantine, inspection, and disposition. The role also supports CAPA and Root Cause Analysis (RCA) investigations, change control, and continuous quality improvement initiatives.

Key Responsibilities:

Vendor Qualification & Requalification:

- Lead the qualification and periodic requalification of vendors and suppliers, including audits, risk assessments, and review of quality agreements.

- Maintain the Approved Vendor List and ensure proper documentation and recordkeeping. Aligned with Document Control and QMS Software.

Materials and Specifications Management:

- Manage creation, review, and maintenance of material specification packets.

- Ensure material specifications align with regulatory requirements and internal quality standards.

- Collaborate with procurement, QC, and compounding teams to ensure material readiness and compliance.

Critical Vendor & Supplies Oversight:

- Develop and manage the critical vendor and supplies list. Be able to classify materials by a risk-based approach.

- Monitor vendor/service provider performance and implement corrective actions as necessary.

Quarantine & Material Disposition:

- Oversee materials through quarantine, inspection, release, or rejection processes.

- Ensure accurate documentation and labeling of material status in inventory systems and physical storage.

CAPA and RCA:

- Lead and support investigations into non-conformances, deviations, and/or complaints.

- Author and review CAPA plans and ensure timely implementation and effectiveness checks.

Change Control:

- Initiate and review, change control requests related to vendors, materials, processes, and documentation.

- Evaluate potential impact on product quality, patient safety and regulatory compliance.

General QA Duties (may be assigned):

- Review and compile executed batch records, including reconciliation and deviation documentation, ensuring completeness and compliance.

- Review, draft, and revise Standard Operating Procedures (SOPs), and policies to reflect current practices and regulatory requirements.

- Participate in internal and external audits, inspections, and regulatory agency interactions, including preparation of documentation and responses to observations.

- Support training initiatives by providing QA-related training sessions and mentoring junior staff in best practices and quality systems.

- Collaborate with cross-functional teams (e.g., Compounding, QC, Supply Chain) to ensure compliance and timely resolution of quality issues.

- Assist in the review and writing of validation protocols and final reports (e.g., equipment, process, cleaning validations) as required.

- Support implementation and maintenance of electronic quality management systems (eQMS) for document control, training, and quality processes.

- Provide QA support during scale-up activities, and introduction of new materials, equipment, or processes.

- Perform other duties as assigned by QA Management to support departmental goals, operational needs, and overall regulatory compliance.

Required Qualifications:

- Experience with vendor qualification, materials management, and quality systems (CAPA, change control, etc.).

- Minimum 3 years of experience in a regulated pharmaceutical, biotech, or compounding environment.

- Excellent organizational, analytical, and communication skills.

- Ability to work independently and collaboratively in a fast-paced environment.

Preferred Qualifications:

- Bachelor's degree in Life Sciences, Chemistry, or a related field.

- Experience with sterile or non-sterile pharmaceutical compounding operations.

- Familiarity with ERP/inventory management systems.

- Auditor certification or experience conducting vendor audits (paper and/or in-person).

The duties and responsibilities listed in this job description are illustrative ones anticipated for this position. Other duties and responsibilities may be assigned, as required. Revive Rx reserves the right to amend or change this job description to meet the needs of the program. This job description and any attachments do not constitute or represent a contract.