LCAT: Quality Assurance Specialist Level: IV Ft. Detrick, MD
Ft. Detrick, MD
Purchasing - Procurement
LCAT: Quality Assurance Specialist Level: IV
GS Equivalent: 14
Requiring Office: Joint Project Manager Medical Countermeasures Systems (JPM MCS)
Team: Staff Support Location: Ft. Detrick, MD – On-site
# of FTEs: 1
Sub-Title: Chief Quality Officer
Experience and/or Certifications Required
The contractor shall possess knowledge of quality assurance principles and practices as a function of a Quality Management System (QMS).
The contractor shall possess knowledge of the relationship of QA to other activities (e.g., program management, contract administration, technical requirements, etc.).
The contractor shall possess knowledge in Industry-accepted quality standards (i.e., International Standards Organization (ISO) 9001 philosophy, regulations, and Industry technical data convention).
The contractor shall possess expertise in reviewing requirements, specifications, and documentation to gain a thorough understanding of the programs and processes to be certified.
The contractor shall be capable of establishing effective interpersonal relationships, as well as an ability to communicate efficiently, both in writing and orally.
The contractor shall possess comprehensive knowledge of the Microsoft Office suite of software (e.g., Word, Excel, PowerPoint, etc.) to create documents, reports, and presentations.
The contractor shall possess knowledge of QA methods, including statistical analysis and sampling techniques.
The contractor shall possess knowledge of the relationship between QA and FDA regulations.
The contractor shall possess demonstrated experience in conducting studies and investigations and root cause/problem analyses, and developing logical documented recommendations.
The contractor shall possess, at minimum, a Lean Six Sigma green belt certification, or its equivalent.
Performance Based Tasks Required
The contractor shall perform on-going quality oversight of organization operations including acquisition, contract, and business management support.
The contractor shall perform the assessment, development, implementation, and evaluation of program and process components.
The contractor shall develop quality processes that meet user requirements.
The contractor shall establish quality goals and engineering approaches which are acquisition phase appropriate, realistic, and feasible in order to meet program cost, schedule, and performance parameters.
The contractor shall develop resource-effective quality engineering plans and solutions, as well as innovative approaches to quality process implementation, from the Engineering and Manufacturing Development (EMD) phase to transition into Low-Rate Initial Production (LRIP) and Full-Rate Production (FRP), and within Industry-accepted standards and best public and private sector practices. In addition, the contractor shall create and implement quality plans and checklists to support project goals.
The contractor shall perform quality planning, quality control activities, and quality assurance audits and reviews.
The contractor shall review and provide comment to contractor quality program plans and documentation, conduct contractor quality audits (as necessary), and assure the delivered product conforms to the contractor’s Technical Data Package (TDP).
The contractor shall validate results, report discrepancies, and follow through to ensure that all issues are resolved.
The contractor shall provide guidance and instruction to others in performing quality assurance activities (e.g., maintaining quality records, performing quality audits, maintaining quality assurance standards, etc.) in order to meet evolving Industry and Government quality requirements.
The contractor shall use approved quality metrics (e.g., process control limits, thresholds, root cause analysis) to evaluate vendor compliance with the requirements and specifications defined in acquisition contracts.
The contractor shall coordinate (e.g., preparing and staffing agendas, etc.), participate in, and document (i.e., meeting minutes) project meetings.
The contractor shall prepare briefing materials.
The contractor shall provide metrics on each program and conduct internal inspections, including data collection and creation of reports with the appropriate statistical methods.
The contractor shall analyze and investigate quality trends or conditions, propose corrective actions when necessary, and monitor results to facilitate continuous process improvement.
The contractor shall assist in the development and training of processes that ensure product quality.
The contractor shall perform document control functions (e.g., workflow initiation; tracking; processing; review; distribution; release and maintenance of SOPs, forms, and other quality documents; etc.) in the Livelink electronic document management system.
At CLD, we understand that it takes insightful senior leadership and managers with strong organizational and technical expertise, working with highly motivated teams of professionals to earn the trust of our customers. CLD takes great prides in our commitment to both our customers and our employees.
CLD's business expertise and support services span a range of solutions, services and geographical locations. CLD’s core capabilities in the areas of information systems security, systems integration & acceptance services, integrated technical services, database management services, and programming services put us in the vanguard of a rapidly changing technological environment.