Leidos Health Group has an opportunity for a Quality Assurance Lead supporting the Leavenworth Consolidated Mail Outpatient Pharmacy (CMOP) Automated Prescription Fulfillment System (APFS) project. This position includes involvement of working with Leidos and subcontractor staff on the assembly, manufacturing, installation, testing, and operationalization of pharmacy automation equipment and ancillary equipment that comprise an Automated Prescription Fulfillment System at the VA CMOP location, to include subcontractors that provide the Uninterruptible Power Supply (UPS) and Warehouse Management System (WMS) capabilities. The QA Lead will be engaged in monitoring Leidos and subcontractor processes to ensure quality, compliance, accuracy and requirement satisfaction during the procurement, manufacturing, installation, and acceptance testing phases. The QA lead will work with Leidos leadership to establish the quality performance measurements. Additionally, the QA lead will monitor integration between the pharmacy control system, the warehouse management system, and VA patient order and supply chain interfaces. The QA Lead will coordinate and collaborate with VA customer staff. The QA Lead will also monitor and assess the software development lifecycle and the software process artifacts generated for accuracy and compliance.
The Quality Assurance Lead manages the quality assurance activities across the entire program lifecycle. This includes establishing and monitoring the performance/quality measurements to ensure requirement satisfaction for performance measures. The Quality Assurance Lead will interface with subcontractors to ensure their quality management systems are implemented and that objective evidence exists to demonstrate compliance to documented plans, processes and procedures. The QA Lead serves as the member of a team with the responsibility to ensure the highest quality system and subsystems are provided to our customer through the generation and control of program processes, performance of regularly scheduled internal process audits and the consistent facilitation of structured improvement activities. The successful candidate will be an agent for change, possess high energy, have a passion for quality, and be self-motivated.
The position is located on-site at a highly-controlled government mail order pharmacy facility in Shawnee/Lenexa, Kansas.
- The Quality Assurance Lead is responsible for leading the internal quality monitoring process and evaluating the performance of production processes and procedures and coordinating with VA on quality issues.
- Develop, implement, and maintain the technical quality assurance and control system for the program. Lead the development and implementation of procedures and plans (e.g. Quality Management Plan, Quality Control Plan) and procedures for assuring quality products and services.
- Develop and improve processes and procedures to meet and exceed acceptable quality levels for program performance standards, with specific emphasis on SDLC and quality measurements.
- Develop and maintain a Quality Control Plan to ensure that all required services are performed in accordance with task order terms and conditions. Develop and implement procedures in the QCP that identify, prevent, and ensure non-recurrence of marginal performance. Initiate changes in processes and practices to ensure effectively manage performance. Initiate corrective action when any tasks are deficient or substandard.
- Implement audit practices for internal processes and products.
- Ensure adherence to all standards, policies, and best practices.
- Support the development and collection of performance metrics. Provide the program manager with timely metrics and audit outcomes to gauge progress towards quality objectives.
- Develop Quality weekly and monthly reports that provides measurements with trends over time and highlights performance issues with mitigation strategies. Report quality status and quality issues, with resolution plans, at weekly and monthly status meetings.
- Coordinate/collaborate with the government, Leidos and subcontractor personnel for validation of the effectiveness of quality assurance procedures and controls; monitors, reviews, and reports assessment results of Leidos performance against defined contractual standards; and validates compliance with SOPs and VA policies.
- The onsite Quality Lead will support the government requested activities by coordinating the availability of program, project, and operational documents; providing data requested as part of onsite and remote audits; providing access to all source materials and associated metadata.
- Establish and maintain strong and productive relationships with key stakeholders ensuring that the objectives are understood and incorporated into a framework of continuous improvement.
- Bachelor’s degree and 2-4 years of prior relevant experience or Masters with less than 2 years of prior relevant experience.
- Auditing experience ensuring compliance to quality management standards (e.g. ISO 9001)
- Knowledge of and experience with industrial automation tools and processes
- Experience maintaining high levels of quality in a production environment.
- Experience working with documentation and data that contains Personally Identifiable Information (PII) and Protected Health Information (PHI).
- Expertise with peer reviews and process auditing.
- Experience collecting and analyzing metrics.
- Experience determining the resources required to maintain quality control.
- Strong communication and writing skills with emphasis on communications with government customers and third-party stakeholders.
- Strong computer skills, including proficiency with MS Office Products (Word, Excel, Visio, PowerPoint, & Project), QA applications and databases.
- Ability to multi-task, complete tasks without direct supervision, and function in a dynamic, fast-paced environment
- ISO 9001 trained
- Knowledge of ITIL and Agile methodologies.
- Lean Six-Sigma Green Belt trained or Certified Lean Six-Sigma Black Belt
- Certifications to include Quality Auditor, Quality Engineer, Quality Improvement Associate, ITIL v3 Foundation
- Formal auditor training
- Experience with the mail order pharmacy processes
- Experience with VA, DoD, or other Federal business processes; business process automation and business process integration efforts
- Familiarity with the Federal Government work environment
External Referral Bonus:
Potential for Telework:
Clearance Level Required:
ADP1 / IT2
Yes, 10% of the time
Scheduled Weekly Hours:
Testing and Quality Assurance
Leidos is a Fortune 500® information technology, engineering, and science solutions and services leader working to solve the world's toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company's 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported annual revenues of approximately $10.19 billion for the fiscal year ended December 28, 2018. For more information, visit www.Leidos.com.
Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here.
Leidos will never ask you to provide payment-related information at any part of the employment application process. And Leidos will communicate with you only through emails that are sent from a Leidos.com email address. If you receive an email purporting to be from Leidos that asks for payment-related information or any other personal information, please report the email to firstname.lastname@example.org.
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.
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