Quality Assurance Specialist II

QA Specialist II

Locations
Durham, NC
US-REMOTE-DC
USA-Remote (Any)

Time Type: Full time
Job Requisition Id: Requisition – 2023200856

Job Summary:
The Quality Assurance (QA) Specialist position develops, implements, and conducts the spectrum of quality assurance and quality control (QA/QC) 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 input of data in internal database, supports product quality investigations, reviews/analyzes data and documentation and develops internal and client specific reports.

Accountabilities:

• Provides input for and revisions of assigned related documents including Standard Operating Procedures (SOP’s) and reports.
• Provides updates to and maintains internal ISO 9001 and 17025 quality management systems.
• Supports data entry and data reviews to ensure quality and compliance standards are met with applicable regulations, project policies, and procedures.
• Keeps current on regulations and guidance.
• Collects materials for and helps maintain files and information management systems.
• Interacts with various external stakeholders to collect data and implement required actions for QA/QC oversight.
• Serves as the liaison with internal and external partners to ensure effective collaboration efforts.
• Develops internal and client specific reports that are a component of routine product and supplier oversight.
• Provides support to data management team to improve data quality.
• Performs other duties as assigned.

Applied Knowledge & Skills:

• Working knowledge of concepts, practices and procedures for conducting quality assurance and/or quality control activities according to industry standards.
• Strong knowledge of software programs used to perform data analysis and reviews.
• Excellent oral and written communication skills.
• Proficiency in Microsoft Office, databases, spreadsheet software and other technology required.
• Ability to analyze and interpret data, identify errors and prepare reports
• Ability to proactively communicate with internal management issues that may result in process non-compliances.
• Ability to read, write and speak proficient English.

Problem Solving & Impact:

• Works on problems of moderate scope that require a review of various factors.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Decisions generally affect own job or specific functional area.

Supervision Given/Received:

• Receives general instructions on routine work, detailed instructions on new projects or assignments.
• Typically reports to a Manager/Associate Director.

Education: **

• Bachelor’s Degree or its International Equivalent in Life/Social Sciences, Health, International Development, Human Development, Knowledge/Information Services or Related Field.

Experience: **

• Typically requires 3 – 5 years of quality assurance, laboratory, or related experience.
• Non-governmental organization (NGO) experience preferred.
• Must have experience working with USAID/BHA donors.
• Knowledge of health, product quality assurance, supply chains in developing countries desirable.

Typical Physical Demands:

• Typical office environment.
• Ability to spend long hours looking at computer screen and doing repetitive work on a keyboard.
• Ability to sit and stand for extended periods of time.
• Ability to lift/move up to 5 lbs

Technology to be Used:

• Laptop, Microsoft applications (i.e., Office 365, SharePoint, Skype/Zoom/Teams), cell phone/mobile technology, and standard office equipment.

Travel Requirements:

• Less than 10%

The expected hiring salary range for this role is listed below. FHI 360 pay ranges represent national averages that vary by geographic location. When determining an offer amount, FHI 360 factors in multiple considerations, including but not limited to: relevant years of experience and education possessed by the applicant, internal equity, business sector, and budget.

Base salary is only one component of our offer. FHI 360 contributes 12% of monthly base pay to a money purchase pension plan account. Additionally, all US based staff working full-time, which is calculated at 40 hours/week, receive 18 days of paid vacation per year, 12 sick days per year, and 11 holidays per year. Paid time off is reduced pro rata for employees working less than a full-time schedule.

Hiring Salary Range: $58,000- $90,000

This job posting summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.

FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.

Our values and commitments to safeguarding: FHI 360 is committed to preventing any type of abuse, exploitation and harassment in our work environments and programs, including sexual abuse, exploitation and harassment. FHI 360 takes steps to safeguard the welfare of everyone who engages with our organization and programs and requires that all personnel, including staff members and volunteers, share this commitment and sign our code of conduct. All offers of employment will be subject to appropriate screening checks, including reference, criminal record and terrorism finance checks. FHI 360 also participates in the Inter-Agency Misconduct Disclosure Scheme (MDS), facilitated by the Steering Committee for Humanitarian Response. In line with the MDS, we will request information from job applicants’ previous employers about any substantiated findings of sexual abuse, exploitation and/or harassment during the applicant’s tenure with previous employers. By applying, job applicants confirm their understanding of these recruitment procedures and consent to these screening checks.

FHI 360 will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws.

FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.

About Us
FHI 360 is a global organization that mobilizes research, resources and relationships so people everywhere have access to the opportunities they need to lead full and healthy lives. With collaborations in over 60 countries, we work directly with local leaders to advance social and economic equity, improve health and well-being, respond to humanitarian crises and strengthen community resilience. We share data-driven insights and scalable tools that expand access and equity so communities can effectively address complex challenges, respond to shocks and achieve thriving futures.

FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.

FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support a healthy work/life balance.

FHI 360 will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws.