Overview
Tanaq Support Services (TSS) delivers professional, scientific, and technical services and information technology (IT) solutions to federal agencies in health, technology, and other government services. TSS is a subsidiary of the St. George Tanaq Corporation, an Alaskan Native Corporation (ANC) committed to serving Federal customers while also giving back to the Tanaq native community and shareholders.
About the Role
We are seeking an experienced Sr. Quality Management Specialist to join our team in support of a project for the Centers for Disease Control and Prevention. The successful candidate will provide support involving a combination of management, scientific, and regulatory responsibilities, including laboratory quality management support and safety compliance. The Sr. Quality Management Specialist will use prior laboratory experience to contribute to quality practices and understanding.
Responsibilities
- Research, implement, and maintain quality management plans.
- Provide technical assistance to users and team members on requirements of systems and procedures.
- Serve as primary point of contact with client quality managers.
- Coordinate and deliver appropriate training for laboratory staff.
- Gather data and trending of quality measures.
- Prepare and communicate reports on activities and efficiencies.
- Create and deliver training materials on quality management for laboratory staff.
- Create and implement quality management tools.
- Make recommendations to modify or revise programs and practices.
- Lead periodic review of quality management systems to evaluate effectiveness and identify opportunities for improvement.
- Conduct periodic internal and external quality audits.
- Monitor required competency assessments.
- Comply with requirements to successfully complete initial and annual safety training.
- Proof and edit the work of others.
Requirements
Required Skills and Experience
- Minimum 7 years of laboratory experience in laboratory QA/QC methods, preferably in a Current Good Manufacturing Practice (cGMP) regulated environment
- Minimum 7 years of experience with analytics test methods.
- Training and/or working experience with quality management, quality assurance, quality audit, CAPA, LSRB, OLSS, and CLIA compliance.
- Experience in triaging feedback, complaints, non-conforming events, CAPA, and/or document control systems ensuring compliance to established procedures.
- Experience in generating statistical tracking and trending reports to monitor compliance with established quality system requirements and identify areas of improvement.
- Ability to obtain necessary immunizations, including Hepatitis B among others.
Education and Training
- Bachelor’s degree in Physical or Chemical Sciences. Master’s degree in Life Science field strongly preferred.
- ISO 9001-2015 Certified Lead Auditor, ASQ Certified Manager of Quality/Operational Excellence, or similar certification(s) strongly preferred.
- Biosafety Level 2 (BSL-2) training; BSL-3 training is desirable.
- Tier 1 select agent (SA) clearance preferred.
Physical Requirements
- Prolonged periods of sitting at a desk and working on a computer. May need to lift 25 pounds regularly.
- May be exposed to hazardous materials and need to wear Personal Protective Equipment (PPE) to protect against exposure to pathogens and chemicals.
Who We Are
Tanaq Support Services strives to deeply understand and analyze our clients’ vision, needs, and requirements so we may provide alternative solutions, empowering them to choose the best resolution. We aim to achieve excellence by delivering on our commitments to our clients, employees, and partners.
TSS is an Equal Opportunity and Affirmative Action Employer and participates in E-Verify. All employment decisions are based on merit, qualifications, and abilities. We welcome and encourage diversity in our workforce. Our policies provide equal employment opportunity to all employees and qualified applicants without regard to race, color, religion, national origin, sex, age, disability, pregnancy, sexual orientation, gender identity, transgender status, genetic information, protected veteran status, or any other protected characteristic under federal, state, or local laws. For individuals with disabilities who would like to request an accommodation, please contact us for assistance.
