Seneca Holdings
Overview
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.
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.
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.
Equal Opportunity Statement Seneca Holdings provides equal employment opportunities to all employees and applicants without regard to race, color, religion, sex/gender, sexual orientation, national origin, age, disability, marital status, genetic information and/or predisposing genetic characteristics, victim of domestic violence status, veteran status, or other protected class status. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leave of absence, compensation and training. The Company also prohibits retaliation against any employee who exercises his or her rights under applicable anti-discrimination laws. Notwithstanding the foregoing, the Company does give hiring preference to Seneca or Native individuals. Veterans with expertise in these areas are highly encouraged to apply.
Seniority level
Entry level
Employment type
Full-time
Job function
Quality Assurance
Industries
Technology, Information and Internet
#J-18808-Ljbffr
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.
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.
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.
Equal Opportunity Statement Seneca Holdings provides equal employment opportunities to all employees and applicants without regard to race, color, religion, sex/gender, sexual orientation, national origin, age, disability, marital status, genetic information and/or predisposing genetic characteristics, victim of domestic violence status, veteran status, or other protected class status. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leave of absence, compensation and training. The Company also prohibits retaliation against any employee who exercises his or her rights under applicable anti-discrimination laws. Notwithstanding the foregoing, the Company does give hiring preference to Seneca or Native individuals. Veterans with expertise in these areas are highly encouraged to apply.
Seniority level
Entry level
Employment type
Full-time
Job function
Quality Assurance
Industries
Technology, Information and Internet
#J-18808-Ljbffr