Quality Assurance Specialist

I’m helping Equity Medical find a top candidate to join their team full-time for the role of Quality Assurance Specialist.
You will ensure clinical research integrity by upholding rigorous quality and compliance standards.
Compensation:
USD 10K - 15K/year.
Location:
Remote (for Philippines residents)
Mission of Equity Medical:
"Advance clinical research by providing patient-centered trials and expanding access to innovative treatments across diverse communities."
What makes you a strong candidate:
You are proficient in Quality assurance (QA).
English - Fully fluent.
Responsibilities and more:
Position Overview:
- Equity Medical is seeking a detail-oriented and highly organized Quality Assurance Specialist based in the Philippines to support our U.S.-based Quality Assurance team and clinical research operations.
- The Quality Assurance Specialist will support ongoing clinical quality activities, including quality review of clinical research documentation, sponsor and regulatory audit preparation, SOP and Work Instruction management, training compliance, CAPA and quality finding tracking, and maintenance of quality records and systems.
- The ideal candidate has experience in clinical research, Quality Assurance, regulatory affairs, or another regulated healthcare environment and possesses a strong understanding of documentation quality, Good Clinical Practice (GCP), and clinical research compliance.
- This position will work closely with the U.S. Quality Assurance team and other clinical research departments to help maintain consistent quality standards across the organization.
Clinical Quality Assurance:
- Perform quality reviews of clinical research documentation for completeness, accuracy, consistency, and adherence to established requirements.
- Review study and site documentation for compliance with study protocols, Good Clinical Practice (GCP), Company SOPs, sponsor requirements, and applicable procedures.
- Identify documentation gaps, inconsistencies, quality concerns, and potential compliance issues and escalate findings to the Quality Assurance team.
- Document quality review findings clearly and accurately.
- Track identified quality issues and required follow-up through resolution.
- Assist with monitoring quality trends and recurring documentation deficiencies.
- Support ongoing quality oversight activities across Company research sites.
- Maintain accurate and organized quality records, trackers, and supporting documentation.
Sponsor Audit & Regulatory Inspection Preparation:
- Support preparation for sponsor audits, central audits, and regulatory inspections.
- Conduct documentation and audit-readiness reviews as assigned.
- Gather, organize, and review documentation requested for audits and inspections.
- Identify missing or incomplete documentation and coordinate follow-up with appropriate team members.
- Maintain audit-readiness trackers, document request lists, and supporting files.
- Assist with tracking audit findings, responses, commitments, and corrective actions.
- Support preparation and organization of documentation related to audit responses and corrective actions.
- Assist the U.S. QA team with maintaining ongoing audit and inspection readiness across research sites.
Internal Quality Reviews:
- Conduct assigned internal quality reviews of clinical research documentation, records, and processes.
- Evaluate adherence to Company SOPs, Work Instructions, study requirements, and established quality processes.
- Document observations and findings objectively and accurately.
- Prepare quality review summaries and reports for QA leadership review.
- Track identified deficiencies and remediation activities.
- Perform follow-up reviews as assigned to confirm completion of corrective actions.
- Assist with identifying recurring quality trends that may require additional review, training, or process improvement.
SOPs, Work Instructions & Document Control:
- Support the development, review, revision, and maintenance of Standard Operating Procedures (SOPs), Work Instructions (WIs), forms, policies, and other controlled documents.
- Review controlled documents for formatting, consistency, completeness, and adherence to established document-control requirements.
- Maintain SOP and Work Instruction trackers, including version numbers, effective dates, review dates, and document history.
- Coordinate document review and approval workflows.
- Maintain appropriate version control and ensure superseded documents are properly archived.
- Upload and maintain approved documents within the Company's Quality Management System (QMS).
- Track required acknowledgments and training associated with new or revised controlled documents.
- Monitor upcoming document review dates and coordinate required follow-up.
Training & Compliance:
- Support administration and tracking of required clinical research and quality training.
- Assist with development and maintenance of QA training materials.
- Assign and track required SOP, GCP, compliance, and other quality-related training.
- Monitor completion of required training and identify overdue assignments.
- Maintain accurate training records and supporting documentation.
- Generate training and compliance reports for QA review.
- Assist with coordination of internal QA training sessions.
- Support onboarding and ongoing quality training for clinical research staff.
CAPA, Deviations & Quality Findings:
- Support documentation and tracking of corrective and preventive actions (CAPAs), deviations, audit findings, and other quality events.
- Assist with gathering information and documentation related to identified quality concerns.
- Support root cause analysis activities under the direction of the Quality Assurance team.
- Maintain CAPA and quality-action trackers and monitor assigned deadlines.
- Follow up with responsible team members regarding outstanding actions and documentation.
- Review supporting documentation for completeness before QA review.
- Escalate overdue, recurring, or significant quality concerns to QA leadership.
- Assist with follow-up and effectiveness reviews of completed corrective actions as assigned.
Quality Systems & Continuous Improvement:
- Support administration and maintenance of the Company's Quality Management System (QMS) and Learning Management System (LMS).
- Maintain accurate QA trackers, logs, records, and quality metrics.
- Assist with compiling quality data for management reporting.
- Identify recurring quality issues, documentation trends, and potential opportunities for process improvement.
- Participate in quality improvement initiatives and special projects.
- Collaborate with Quality Assurance, Clinical Operations, Regulatory, and other departments to support consistent quality practices.
- Promote a culture of quality, accountability, and continuous improvement.
Required Qualifications:
- Bachelor's degree in life sciences, nursing, pharmacy, medical technology, healthcare, clinical research, or a related discipline.
- At least 1–3 years of experience in clinical research, Quality Assurance, regulatory affairs, clinical operations, or a related regulated healthcare environment.
- Knowledge of Good Clinical Practice (GCP) and clinical research documentation requirements.
- Strong English written and verbal communication skills.
- Exceptional attention to detail and ability to identify documentation inconsistencies and deficiencies.
- Strong organizational and time-management skills.
- Ability to manage multiple assignments and deadlines in a remote environment.
- Proficiency with Microsoft Office and/or Google Workspace.
- Comfortable working with electronic systems, trackers, and document-management platforms.
- Ability to maintain confidentiality and appropriately handle sensitive clinical and business information.
Preferred Qualifications:
- Previous Quality Assurance experience within clinical research.
- Experience working with a clinical research site, site network, CRO, sponsor, or other research organization.
- Familiarity with U.S. FDA clinical research requirements and ICH-GCP.
- Experience supporting sponsor audits or regulatory inspection readiness.
- Experience with CAPAs, deviations, quality findings, and root cause analysis.
- Experience with SOP and controlled-document management.
- Experience with a Quality Management System (QMS), Learning Management System (LMS), CTMS, or other clinical research technology.
- Clinical research or quality certification is a plus but not required.
Key Competencies:
- Strong attention to detail and commitment to accuracy.
- Critical thinking and analytical skills.
- Strong documentation and organizational skills.
- Ability to identify potential quality concerns and appropriately escalate them.
- Professional written and verbal communication.
- Ability to work effectively with a U.S.-based team in a remote environment.
- Ability to work independently while following established QA processes an

Work arrangement
Yes