Quality Assurance Specialist

Great Hill Solutions, LLC is part of the Seneca Nation Group (SNG) portfolio of companies. SNG is Seneca Holdings' federal government contracting business that meets mission-critical needs of federal civilian, defense, and intelligence community customers. Our portfolio comprises multiple subsidiaries that participate in the Small Business Administration 8(a) program. To learn more about SNG, visit the website and follow us on LinkedIn.

Our team of talented individuals is what makes us successful. To support our team, we provide a balanced mix of benefits and programs. Your total rewards package includes competitive pay, benefits, and perks, flexible work-life balance, professional development opportunities, and performance and recognition programs. We offer a comprehensive benefits package that includes medical, dental, vision, life, and disability, voluntary benefit programs (critical illness, hospital, and accident), health savings and flexible spending accounts, and retirement 401K plan. One of our fundamental principles is to offer competitive health and welfare benefits to our team members, providing coverage and care for you and your family. Full-time employees working at least 30 hours a week on a regular basis are eligible to participate in our benefits and paid leave programs. We pride ourselves on our collaborative work environment and culture, which embraces our mission of providing financial and non-financial benefits back to the members of the Seneca Nation.

Great Hill Solutions, LLC seeks a dedicated Quality Assurance Specialist. This role is essential for ensuring laboratory quality and safety standards are met across operations. The specialist will provide consultation, training, and oversight to ensure compliance with federal regulations and CDC policies.

Duties and Responsibilities:

• Provide consultation to CDC staff in the training of quality managers, laboratory staff, senior scientists, and laboratory support staff.
• Translate laboratory quality requirements from the Code of Federal Regulations, international standards, and national standards into functional requirements for laboratories.
• Utilize strategic planning and project management to develop Quality Management System (QMS) implementation strategies within diverse laboratory environments.
• Ensure quality management practices are incorporated across all laboratory operations including diagnostic testing, surveillance testing, research, and product development.
• Assist laboratories in preparing for internal and external audits.
• Perform GAP analyses and generate/review Nonconformance Events (NCEs) and assist laboratories in generating corrective action plans.
• Draft risk assessments and ensure appropriate clearance.
• Communicate agency quality and safety initiatives to branch members.

Required Qualifications:

• Bachelor’s degree (BA/BS) with 0–3+ years’ experience.

Desired Qualifications:

• Work experience in the scientific field, including laboratory safety, quality control, quality assurance, or related field (preferably in a public health setting).
• Knowledge of and experience working with laboratory safety, quality control and quality assurance.
• Knowledge of and experience working with clinical data and working in a clinical laboratory.
• Familiarity with word-processing, presentation, and email software.
• Ability to identify gaps in existing resources.
• Ability to be flexible.
• Interpersonal communication: telephone, email, and business etiquette.
• Strong proofreading skill and attention to detail.
• Strong organizational skills.