Pharmacy Quality Ctrl Spec

Washington, District of Columbia-Washington
Oct 06, 2020
Nov 10, 2020
Full Time
The position requires an understanding and interpretation of USP-797 standards and the ability to apply the standards to development of workflow practices. This person is responsible for evaluating and maintaining compliance of competencies, training records, environmental monitoring and other documents related to USP 797 /800 to ensure IV room processes meets or exceeds requirements. Ensures contamination control through teaching, monitoring and sampling, for disinfection and control of touch contamination.


Minimum Education
High School Diploma or GED

Specific Requirements and Preferences
Bachelor's degree Preferred (Required)

Minimum Work Experience
5 years

Specific Requirements and Preferences
Minimum of 5 years as technician to include 3 years' experience as an IV technician in a health care setting (hospital preferred) or 2 years in 503B compounding facility (Required)
Related-work experience in at least 2 of the following strongly desired: GMP IV compounding, Education and Training of staff on competencies, Analyzing data for purpose of creating Quality Improvement Processes, Quality Assurance or Quality Improvement, Lab technician working with quality control measures and/or sampling .

Required Skills/Knowledge
Training in USP Cleanroom standards for USP including quality standards within the last 5 years OR currently performing related job duties with proof of on-going learning and education (mandatory training updates within 6 months-1 year will be required).
Excellent communication skills (verbal, written and presentation)
Proven time management skills and attention to details
Ability to work independently and in cross-functional teams
Knowledgeable in quality control standards for USP including, environmental monitoring and cleaning and contamination control
Strong analytical and reasoning skills
Excellent interpersonal and professional skills
Self-motivated individual with a positive attitude when educating and training others

Functional Accountabilities

Regulatory Compliance
1. Has primary responsibility for maintaining regulatory compliance for United States Pharmacopeia (USP) standards for all Children's National Health System IV Rooms and compounded sterile products (CSPs) at the Sheik Zayed campus and offsite locations
2. Interpret and apply USP and regulatory standards for the purpose of converting workflow and practice standards to adapt to compliance
3. Develop, coordinate and document education and training processes for staff working in IV or ante rooms to ensure complete compliance with regulatory standards for USP and r all aspects relate
4. Functions as subject matter expert for identifying quality improvements based on gaps with compliance
5. Maintain and manage current, accurate documentation and records required for compliance with regulatory standards

Technical Compliance
1. Supervise all processes related to glove-fingertip testing, media-fill testing and environmental monitoring sampling for employees annually
2. Maintains environmental control of all sterile compounding IV areas including coordination with engineering, facilities, and others as designated to ensure all certifications are current and in date
3. Provide expert knowledge in the appropriate protocols and methodologies for cleaning, disinfecting, and contamination control for all cleanroom locations
4. Track, trend and analyze data for purposes of developing and implementing quality improvement processes aligned with medication safety and compliance with regulatory and practice standards
5. Other duties as assigned

Education and Training
1. Develop, maintain and facilitate comprehensive, quality, educational materials for pharmacy staff and other providers as required, in collaboration with Compliance and Sterile Products Coordinator, and/or Safety Manager.
2. Evaluate all IV room personnel and behaviors during the process of compounding or preparing to compound sterile products for the purpose of and re-training evidenced by documenting the compliance of regulatory standards compared to workflow practices This is done through direct observation, audits, and other available tools
3. Validate evidence of education, training and documented competence of all personnel working in the IV room
4. Ensure pharmacy has written procedures in place to document compliance and interventions
5. Collaborate with other department leaders to educate staff and other providers (as needed) on SOPs and policy information on USP-797/800 standards.
6. Develop, initiate, and oversee training tools and competencies both independently and in collaboration with other department leaders
7. Maintain competence and knowledge in aseptic technique, and environmental monitoring for al staff

Organizational Accountabilities
Organizational Accountabilities (Staff)
Organizational Commitment/Identification
1. Anticipate and responds to customer needs; follows up until needs are met
Teamwork/Communication 1. Demonstrate collaborative and respectful behavior
2. Partner with all team members to achieve goals
3. Receptive to others' ideas and opinions
Performance Improvement/Problem-solving 1. Contribute to a positive work environment
2. Demonstrate flexibility and willingness to change
3. Identify opportunities to improve clinical and administrative processes
4. Make appropriate decisions, using sound judgment
Cost Management/Financial Responsibility 1. Use resources efficiently
2. Search for less costly ways of doing things
Safety 1. Speak up when team members appear to exhibit unsafe behavior or performance
2. Continuously validate and verify information needed for decision making or documentation
3. Stop in the face of uncertainty and takes time to resolve the situation
4. Demonstrate accurate, clear and timely verbal and written communication
5. Actively promote safety for patients, families, visitors and co-workers
6. Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance

Children's National Health System is an equal opportunity employer that evaluates qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender, identity, or other characteristics protected by law.

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