Description

What makes Brillient a GREAT fit for you?

When you join Brillient, you become part of an award-winning Full Spectrum Digital Transformation company focused on helping agencies in the continuum of analog, to digital, to analytics, leading to insight-driven decision making and mission execution.

Our mission is to provide value to our clients and our people, operate with the highest integrity as a trusted business partner, adopt a workstyle that is flexible allowing us to effectively collaborate while being agile and nimble, and be innovative in everything we do. We are passionate about ensuring our employees experience a work environment that is inclusive, professional, and supportive. In addition to these core values, the Brillient team is driven by:

• Focus on Sustainability- Being an environmentally conscious, green company with sustainable practices.
• Impact on the Community- Social responsibility to the communities we live and work in.

At Brillient, we achieve our purpose by hiring brilliant people with passion, drive, capabilities, and experience to help our clients achieve their mission goals through innovation in processes and technologies.

Brillient is a client-centric, employee-focused company with a vibrant culture.

What We Offer (See Our Career Page for Further Details):

An engaging and supportive work environment where every employee is valued, a rewarding career, and outstanding benefits which currently include:

• Ample paid time off
• Medical, Dental, & Vision Plans
• Company Sponsored Wellness Programs
• Paid Life Insurance and STD
• Paid Employee Assistance Program
• Voluntary Life & TD coverage
• 401(k) w. Company Match
• Competitive wages
• Quarterly Performance Development
• Company Discounts
• Continuing Education Support

Who You Are:

• Value based, High Integrity, Flexible, & Innovative

What You Will Do

We are hiring a Quality Assurance Specialist III to work out of our FDA customer locations in either Silver Spring, MD or Beltsville, MD. Roles and responsibilities include:

• Establish and maintain a process for evaluating and validating software and associated documentation.
• Independently, blend scientific experience along with knowledge and background of quality assurance principles and practices to interpret and determine the applicability of quality tools to specific deficiencies and improvements and/or to incorporate quality tools into the St. Louis site’s quality system and/or to create new quality tools.
• Participate in developing, implementing, and maintaining the QMS to maintain ISO 17025 certification.
• Determine the resources required for quality management. The Quality Assurance Specialist III will work with a voluntary quality team as well as management to develop and maintain a QMS.
• Conduct formal and informal reviews of quality elements at predetermined points throughout the development lifecycle.
• Implement procedures to ensure that all information systems, products and services meet organization quality standards and end-user requirements.
• Routinely update management on the status and effectiveness of the QMS.
• Apply a mastery of quality assurance concepts, practices and methodology to effectively participate in the development, implementation, and maintenance of the QMS for the CMC Review Process.
• Perform and lead software validation.
• Document and work to resolve all complex problems related to quality.
• Be responsible for resolution of reported Quality incidents including performing root cause analysis investigations, managing a corrective and preventive action (CAPA) program and performing effectiveness checks as needed.
• Establish and maintain a quality environment based on continuous improvement.
• Act as a Quality Assurance subject matter expert for technical writers and other Quality Assurance Analysts.
• Perform risk analysis of processes and recommend quality improvements.
• Develop and oversee implementation of the Quality Management Plan (QMP) or other established guidelines for the CDER Quality Management Plan (QMP) or other established guidelines for the CDER Quality Management System for the (CMC) Review Process and related activities and supporting internal efforts to align FDA with priority initiatives such as Pharmaceutical cGMPs for the 21st Century.
• Develop tentative/final operating criteria, procedures, protocols, and any other communications pertaining to the QMS.
• Coordinate the resolution of OTR matters related to QMS components, including planning, implementation, and evaluation of process improvement tools utilized.
• Initiate, cultivate, and maintain continual contacts with his/her respective line Office Director and other key staff members within that line office, the OPQ Quality Program
• Manager, Senior Quality Assurance Specialists (Pharmaceuticals) and other OPQ QMS staff within OPQ; key CDER officials, representatives of the pharmaceutical industry and other Federal agencies; and members of academia.
• Assignments typically include a broad range of duties involving substantial breadth and depth of analysis associated with the development, implementation, and maintenance of QMS, activities within the respective line office such as developing methods for evaluating accomplishments and trends and making recommendation for improvements to the CMC review process and supporting activities.
• The work is primarily sedentary in nature and requires only normal sitting, standing, bending, and carrying of light objects.
• The work is typically performed in a climate-controlled office with adequate light. Occasional travel may be required to participate in the full range of duties.

Required:

BS/BA 6 years or more of experience

Diversity, Inclusion, & Engagement at Brillient:

At Brillient, we not only accept difference, we promote it, we embrace it, and we thrive on it for the betterment of our patients, our employees, and our culture.

We are proud to be an equal opportunity workplace and an affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status or any other status protected under applicable law.

Qualifications