## Job Overview
We are seeking a skilled Quality Assurance Engineer III to join our team. The ideal candidate will be responsible for ensuring that our products meet the highest quality standards through meticulous inspection and analysis.

## Duties
· Establish and maintain a process for evaluating and validating software and associated documentation.

· Independently, the Quality Assurance Specialist III shall 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 shall 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.

## Qualifications
- BS/BA degree .
- Minimum of 6 years of experience in quality assurance .
- Strong knowledge of FDA regulations, and quality assurance methodologies.
- Excellent analytical skills and attention to detail.
- Effective communication and problem-solving abilities.

Job Type: Full-time

Pay: $87,500.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Professional development assistance
• Referral program
• Retirement plan
• Vision insurance

Schedule:

• Monday to Friday

Application Question(s):

• Are willing to undergo and pass a financial and criminal government background check?

Experience:

• Quality Assurance: 6 years (Preferred)

Language:

• and write English proficiently (Preferred)

Security clearance:

• Confidential (Preferred)

Ability to Commute:

• Silver Spring, MD 20903 (Required)

Ability to Relocate:

• Silver Spring, MD 20903: Relocate before starting work (Required)

Work Location: Hybrid remote in Silver Spring, MD 20903