Job Title: Quality Management Specialist - GMP/Pharma
Location: Rockville, MD
Duration: 6 months contract
Job Description:
The QA Specialist II – Supplier Quality Management and Quality Systems will support in the development and maintenance of quality systems for the management of suppliers that provide critical and controlled materials for GMP-related operations and inspection readiness. This includes but is not limited to the following:
Key Responsibilities and Duties:
- Conduct supplier audits worldwide, write the relevant audit reports, and keep the suppliers' CAPA monitored to ensure compliance with the applicable regulations.
- Participate in due diligence of new suppliers/projects as applicable to quality-related aspects.
- Ensure that Management is informed of critical findings resulting from supplier audits.
- Support the Quality Assurance Department when major and critical issues occur with the suppliers of materials and GXP-related services and, when needed, carry out "for-cause " audits.
- Support the Global Supply Chain with the introduction of new suppliers.
- Begin and complete the initial qualification, requalification, and discontinuation requirements of suppliers.
- Complete assessments of new suppliers and changes to scope of work for approved suppliers.
- Review the material specifications for their conformance to internally established procedures.
- Lead the risk assessment process for vendor classification.
- Review and maintain vendor qualification associated documentation.
- Serve as the lead auditor during the vendor qualification process.
- Provide information to end users (stakeholders) on the vendor qualification status on a monthly basis.
- Participate in the global vendor qualification process and serve as the committee site representative.
- Prepare annual vendor performance report and maintain QA vendor file.
- Support client and regulatory authorities and provide the necessary information to answer questions related to supplier management.
- Manage the Quality Agreements with suppliers of critical materials and GXP-related services.
- Manage the supplier-related software and supplier databases.
- Perform the annual assessment of suppliers and write the supplier status certificates.
- Review the Material Specification and Disposition documents upon initiation or revision.
- Establish and maintain Investigation, Deviation, CAPA, Effectiveness Verification systems, and internal and external audit.
- Provide oversight and guidance to ensure timely and compliant execution of quality records.
- Perform trending, risk assessments, and report key quality metrics to management and QMR.
- Evaluate CAPA effectiveness and identify systemic improvements.
- Oversee supplier qualification, audits, and performance monitoring.
- Manage supplier quality issues, escalation, and quality agreements.
- Conduct supplier audits and ensure CAPA effectiveness.
- Drive continuous improvement and ensure regulatory compliance (FDA, EMA, ICH).
- Support audits, inspections, and inspection readiness activities.
- Collaborate cross-functionally to maintain quality and compliance standards.
- Participate in recruiting, training, and mentoring activities.
- Additional duties as assigned.
Qualifications:
- BS/BA in Life Sciences or related field.
- Minimum 5 years GMP experience in pharmaceutical/biopharmaceutical industry.
- Experience in Quality Systems and Supplier Quality Management.
- Strong knowledge of GMP regulations and quality systems.
- Excellent communication, organizational, and analytical skills.
- Experience with electronic quality systems (e.g., TrackWise, EDMS systems, SAP) preferred.
Pay: $25.00 - $28.00 per hour
Work Location: In person
