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Quality Assurance Specialist III
$84k-101k (estimate)
Other | IT Outsourcing & Consulting 10 Months Ago
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Brillient Corporation is Hiring a Quality Assurance Specialist III Near St. Louis, MO

Job Details

Job Location: FDA: CDER, St. Louis, MO - St. Louis, MO
Salary Range: Undisclosed

Description

General Summary: Brillient Corporation is currently seeking a Quality Assurance Specialist III to join it's Team supporting a federal contract, FDA. 

Essential Job Functions:

  1. Review events to ensure investigations are thorough and support conclusions. Provide guidance to staff regarding appropriate content for each section, level of detail required, ratings, and recommendations for CAPAs.
  2. Review change controls to ensure the scope, impact assessments, and action items are appropriately documented. Provide guidance to staff regarding appropriate content for each section, level of detail required, ratings, and effectiveness checks.
  3. Review SOPs to ensure the content is accurate, clear, and compliant with the requirements of ISO 17025. Provide guidance to staff regarding organization of content and formatting.
  4. Perform comprehensive internal audits to ensure components of the quality management system are compliant with site procedures and ISO 17025.
  5. Develop and provide training to staff.
  6. Support process improvement projects and collaborate with the Quality Manager, site management, lab staff, and support staff.
  7. The work is primarily sedentary in nature and requires only normal sitting, standing, bending, and carrying of light objects.
  8. 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.
  9. Performs other related duties as assigned.

Education Requirement: Bachelors’ Degree

Experience Requirement: Minimum six (6) years’ experience performing related duties. 

Additional Requirements:

1. Prior experience in a regulated laboratory environment and quality systems.

2. Minimum of 6 years’ experience managing and completing QMS functions as primary role:

Internal audits
SOPs
Events
CAPAs
Change controls
Effectiveness checks
Supplier quality
Equipment qualifications
Developing and providing training
Process improvement projects
3. Must proactively initiate tasks and projects.
4. Must have exceptional written and verbal communication skills.
5. Advanced skills in Word and Excel preferred.

Other Requirement(s): This position requires U.S. Citizenship or a Green Card holder and the ability to obtain and maintain a Government public trust level security clearance. For a candidate that is a Green Card holder, they must have lived in the United States for at least three out of the past five years prior to your application date. You will also meet the residency qualifications if you lived abroad while on government or military duty or if you were a dependent of a federal employee of military member.

Performance Requirements:

  1. Excellent verbal and written communication skills.
  2. Excellent interpersonal and customer service skills.
  3. Excellent organizational skills and attention to detail.
  4. Excellent time management skills with a proven ability to meet deadlines.
  5. Strong analytical and problem-solving skills.
  6. Strong supervisory and leadership skills.
  7. Proficient with Microsoft Office Suite and SharePoint.

Equipment Operated: Standard office equipment including computers, fax machines, copiers, printers, telephones, etc.

Work Environment: Work performed in an office environment. Involves frequent contact with staff and customers.

Mental/Physical Requirements: Manual dexterity for office machine operation; stooping, bending to handle files and supplies, mobility to complete errands or deliveries. Must be able to remain in stationary position for extended periods of time. Stress can be triggered by multiple demands and deadlines.

DISCLAIMER: The above statements are intended to describe the general nature and level of work performed. They are not intended to be an exhaustive list of all responsibilities, duties, skills, efforts, requirements, or working conditions. Management reserves the right to revise the job or to require that other or different tasks be performed as assigned in accordance with business demands and/or contractual requirements.

Qualifications


Job Summary

JOB TYPE

Other

INDUSTRY

IT Outsourcing & Consulting

SALARY

$84k-101k (estimate)

POST DATE

05/18/2023

EXPIRATION DATE

08/11/2023

WEBSITE

brillient.net

HEADQUARTERS

RESTON, VA

SIZE

500 - 1,000

FOUNDED

2006

TYPE

Private

CEO

PAUL STRASSER

REVENUE

$10M - $50M

INDUSTRY

IT Outsourcing & Consulting

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About Brillient Corporation

Brillient is an engineering service firm that provides business process management, cloud integration and IT support services for the public sector.

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