Quality Assurance Specialist

Quality Assurance Specialist

We are currently searching for a Quality Assurance Specialist to provide support to the US Food & Drug Administration in the following locations: St. Louis, MO, Silver Spring, MD.

What You Will Do:

• Participate in developing, implementing, and maintaining the Quality Management System (QMS) to maintain ISO 17025 certification.
• Establish and maintain a process for evaluating and validating software and associated documentation.
• Conduct formal and informal reviews of quality elements 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.
• Perform and lead software validation.
• Document and resolve complex problems related to quality.
• Perform root cause analysis investigations, manage a corrective and preventive action (CAPA) program, and perform effectiveness checks as needed.
• Develop and oversee the implementation of the Quality Management Plan (QMP) or other established guidelines for the Chemistry Manufacturing and Controls (CMC) Review Process.
• Coordinate the resolution of OPQ matters related to QMS components, including planning, implementation, and evaluation of process improvement tools utilized.
• 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.

What You Will Need:

• A bachelor's degree in Life Sciences or a relevant field such as Quality Assurance, Engineering, or a related discipline.
• A minimum of TWO (2) years of experience in quality assurance concepts, practices, and methodology.
• Experience in developing, implementing, and maintaining QMS.
• Strong analytical and problem-solving skills.
• Ability to work independently and as part of a team.
• Excellent communication and interpersonal skills.
• Proficiency in software validation, regulatory operations, and quality documentation.

What Would Be Nice To Have:

• Experience with ISO 17025 certification.
• Familiarity with the FDA regulatory submissions and product reviews.
• Knowledge of continuous improvement processes.
• Experience in coordinating with various stakeholders, including quality managers, regulatory staff, and scientific discipline/department leadership.
• Ability to develop tentative/final operating criteria, procedures, protocols, and other communications pertaining to the QMS.

What We Offer:

Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.

Benefits include:

• Medical, Rx, Dental & Vision Insurance
• Personal and Family Sick Time & Company Paid Holidays
• Parental Leave
• 401(k) Retirement Plan
• Group Term Life and Travel Assistance
• Voluntary Life and AD&D Insurance
• Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts
• Transit and Parking Commuter Benefits
• Short-Term & Long-Term Disability
• Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities
• Employee Referral Program
• Corporate Sponsored Events & Community Outreach
• Care.com annual membership
• Employee Assistance Program
• Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)
• Position may be eligible for a discretionary variable incentive bonus

About Guidehouse:

Guidehouse is an Equal Opportunity EmployerProtected Veterans, Individuals with Disabilities or any other basis protected by law, ordinance, or regulation.

Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.

All communication regarding recruitment for a Guidehouse position will be sent from Guidehouse email domains including @guidehouse.com or guidehouse@myworkday.com. Correspondence received by an applicant from any other domain should be considered unauthorized and will not be honored by Guidehouse.

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.