The Quality Assurance (QA) Specialist position develops, implements, and conducts the spectrum of quality assurance activities for health-related products in working with senior staff. The position will be responsible for ensuring compliance with applicable regulatory requirements and industry standards, support audits and investigations and reviews/analyzes data and documentation.
Areas of Responsibility:
- Develop, review and revise assigned related documents including Standard Operating Procedures (SOP’s) and reports for evaluation of product/manufacturer information, technical evaluations and associated processes.
- Receipt and management of confidential project and product/manufacturer information.
- Evaluation of product/manufacturer information, for a range of products (HIV Commodities, Reproductive Health Commodities, Maternal and Child Health Commodities) in accordance with Model Quality Assurance for Procurement Agencies to assess compliance with international standards, sponsor requirements and other as applicable
- Oversees and reviews data to ensure quality and compliance standards are met.
- Communication with offerors to resolve queries and complete product evaluation activities.
- .Support the development and maintenance of quality systems for QA oversight and processes to achieve compliance to WHO Guidelines for Model Quality Assurance Systems for Procurement Agencies
- Ensures that the program quality management system is updated and maintained and provides input on potential improvements to the system.
- Keeps current on and disseminates information regarding regulations and guidance.
- Collects materials for and helps maintain files and information management systems. Evaluates compliance with and applicable regulations, project policies, and procedures.
- May act as team lead and mentors staff on training, systems, policies, and regulations.
- Serves as the liaison with internal and external partners to ensure effective collaboration efforts.
- May be requested to support quality system audits for selected product suppliers, prepare audit reports, and monitor corrective action implementation as needed.
- Liaise with Product Quality Incident Management, collaborators and suppliers and others as necessary to resolve product complaints.
- Participate in internal audits and accreditation activities.
- Performs other project related duties as assigned
Educational Background:
Master’s Degree or its International Equivalent • Pharmaceutical chemistry, pharmacology, regulatory, Life Sciences or Related Field.
Skills/Experience:
- Strong knowledge of concepts, practices and procedures for regulatory and quality requirements (WHO Prequalification, US FDA and EU)of Finished Pharmaceutical Products, dosage forms, and Medical Devices relating to HIV AIDS, Reproductive Health and Tuberculosis Prevention Treatment
- Knowledge of concepts, practices and procedures of Model Quality Assurance for Procurement Agencies and international regulatory standards
- Experience with pharmaceutical product dossier compilation and review
- Experience working with developing countries is a plus
- Strong knowledge of software programs used to perform data analysis.
- Excellent oral and written communication skills.
- Ability to analyze and interpret data, identify errors and prepare reports and presentations
- Results oriented and demonstrated ability to achieve desired results.
- Must be eligible to work in the United States of America.
Problem Solving & Impact:
- Works on problems of diverse scope that require analysis or interpretation of identifiable factors.
- Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
- Decisions may affect a work unit or area within a department.
- Typically requires 5-8 years of quality assurance, laboratory, or related experience.
- Proficiency in Microsoft Office, SharePoint, databases, spreadsheets, analytical software and other technology required. Power BI a plus
- Articulate, professional and able to communicate in a clear, positive fashion with clients at all levels and staff.
- Must be able to read, write and speak fluent English. Bilingual (English/French) communication skills may be ideal.
- Experience in Quality Assurance and/or Regulatory Dossiers for Pharmaceuticals/Medical Devices and, Risk Management
Supervision Given/Received:
- Receives methods and procedures on new on routine work, detailed instructions on new projects or assignments.
- Provides suggestions on business and operational decisions that affect the department.
- Serves as team lead to team members.
- Typically reports to a Manager/Associate Director.
Typical Physical Demands:
- Typical office environment.
- Ability to sit and stand for extended periods of time.
- Ability to lift 5-50 lbs.
Technology to be Used:
- Personal Computer, Microsoft Office (i.e. Word, Excel, PowerPoint, etc.), e-mail, telephone, printer, calculator, copier, cell phones, PDAs and other hand held devices.
Compensation/Benefits:
FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.
Job Function:
Organization Info
Listing Stats
Post Date:
Aug 15 2019
Active Until:
Sep 15 2019
Hiring Organization:
Fhi 360
industry:
Nonprofit