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Senior Quality Assurance Specialist

2 months ago

Manassas, United States ATCC Full time


Senior Quality Assurance Specialist

Job Locations

US-VA-Manassas

Role Type

Hybrid

Department

Compliance & Quality Assurance

Job ID

2024-3842

Scientific Background

Biology

Overview

The Senior Quality Assurance Specialist is responsible for maintaining, ensuring adherence to, and improving upon processes promoting consistency, identifying deviations, preventing defects, and eliminating problems before they occur. They ensure products and processes comply with internal and external regulations and quality standards. They support the development, implementation, and administration of the Quality Assurance Program. This is a hybrid role based in Manassas, VA.

The Senior Quality Assurance Specialist works on tasks of diverse scope where analysis of situations or data requires evaluation and judicious application of a variety of factors. They demonstrate good judgment in selecting methods and techniques for obtaining solutions. They normally receive little instruction on daily work and general instructions on new assignments. They mentor and train other staff to perform quality assurance activities. They perform within defined procedures and practices and adjust or develop new procedures when necessary to address emerging situations.

#LI-Hybrid

Responsibilities

  1. Support the organization to apply relevant quality standards and establish appropriate quality assurance processes to ensure compliance to those standards. Evaluate relevant changes to industry standards and practices to improve the organization's quality assurance systems.
  2. Evaluate internal controls, communications, risk management and maintenance of documentation, such as Standard Operating Procedures (SOPs), to assess compliance with internal and external safety, quality, and regulatory standards.
  3. Provide support in the management of controlled documents to include writing, formatting, uploading, maintenance, and document changes, while also maintaining physical and archived documents using industry standard document control, change control practices and information technology systems. Assist with determining requirements for records retention, storage and disposal for business activities governed by the quality assurance systems.
  4. Work with internal departments/business units to identify nonconformities and support developing appropriate remedies and corrective actions. Additionally, identify risks and support departments in developing preventive actions.
  5. Develop and deliver internal training on quality assurance requirements, processes, and procedures. Mentor and train quality assurance staff to perform quality assurance activities in accordance with the established quality assurance systems.
  6. Lead cross-functional teams to evaluate process effectiveness and develop and implement process improvement.
  7. Schedule, plan, and lead or participate in internal and vendor audits and risk assessments to ensure compliance with documented procedures. Prepare and present audit reports. Support departments with resolution and monitoring of any identified action items.
  8. Prepare, maintain, analyze, and present metrics related to quality assurance activities for management review. Support management in evaluating organizational performance against quality goals and assist in developing performance improvement plans. Assist with the implementation of any resultant action items.
  9. Advise internal customers to support achieving organizational quality goals and objectives while ensuring compliance to organizational SOPs.
  10. Perform duties on behalf of the Manager, Quality Assurance, as delegated.


Qualifications

Education and Experience:

  • Bachelor's degree and 5 or more years' experience or equivalent experience.

Knowledge, Skills and Abilities:

  • Excellent interpersonal and communications skills
  • Excellent organization and analytical skills
  • Ability to work alone or within a cross-functional team environment
  • Ability to foster high degree of customer satisfaction


Benefits

We Invest in You

  • Health & Wellness:
    • Comprehensive medical coverage and company paid Life Insurance, Disability Insurance & AD&D
    • Work life balance with Paid Holidays and PTO
    • Fitness and cell phone subsidies, and additional benefits such as Aflac, legal services, and pet insurance
    • Employee Assistance Program offering around-the-clock counseling
  • Financial security:
    • 401(a) (6% employer contribution) and 403(b) (2% match) retirement plans
    • Exceptional career advancement opportunities, recognition, and rewards
    • Corporate bonus program
  • Mission Focused:
    • Non-profit organization supporting critical life science research
    • We give scientists the tools they need to make discoveries that improve and save lives
    • Contribute to community involvement and social responsibility

Join ATCC, where we fuel your success, well-being, and development. We're a mission focused non-profit Equal Opportunity Employer, championing diversity and inclusivity. When you work at ATCC, you become a part of that mission, one we've committed to for almost 100 years.Shape the future of science with us.

ATCC is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.