Pharmacy Quality Control Engineer

Children's National Hospital•Washington, DC

7d•$77,584 - $129,293•Onsite

About The Position

The Pharmacy Quality Control Engineer is responsible for evaluating and maintaining compliance with competencies, training records, environmental monitoring, and other documents related to USP 797/800 to ensure IV room processes meet or exceed requirements. The position ensures contamination control through preventative maintenance, teaching, monitoring, and sampling for disinfection and control of touch contamination. This position also assures all aspects of small/medium-sized pharmacy construction project management are compliant including, but not limited to, plans review for technical completeness, schedule development/review/approval, environment of care compliance and construction effectiveness, communication with user departments, budget oversight and contingency management, contractor supervision and construction quality assurance meeting all USP standards across all CHN pharmacy locations. This position assists with the quality assurance and compliance with all other projects under management at CNH. The position requires an understanding and interpretation of USP 797/800/825 standards and the ability to apply the standards to develop workflow practices, ensure facility compliance, and maintain all physical requirements of pharmacy space including all sterile locations.

Requirements

High School Diploma or GED (Required)
Associate's Degree Degree in engineering or construction related field; or equivalent experience (Required)
3 years working in engineering/construction field (Required)
Training in USP Cleanroom standards for USP<797/ 800> 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 detail
Ability to work independently and in cross-functional teams
Knowledgeable in quality control standards for USP <797/800> 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
Proven ability to manage construction jobs on time and within budget
In-depth knowledge of construction means and methods combined with a proven ability to problem solve job site problems and coordination issues

Nice To Haves

Bachelor's Degree (Preferred)
3 years Project management supervision and quality assurance experience with creating project schedules, supervising construction trades (both internal employees and third-party contractors), utilizing project management software (Preferred)
Minimum of 1 year (3 years preferred) as pharmacy technician to include experience as an IV technician in a health care setting (hospital preferred) or in a 503B compounding facility (Preferred)
1 year 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 the purpose of creating Quality Improvement Processes, Quality Assurance or Quality Improvement, Lab technician working with quality control measures and/or sampling (Preferred)
Pharmacy Technician (CPhT) Current, active pharmacy technician certification in the District of Columbia required (Preferred)
Recent training in USP <797> standards with proof of on-going education within the last 3 years strongly desired (Preferred)
Certification in or toward 503A or 503B training preferred (Preferred)

Responsibilities

Has primary responsibility for maintaining regulatory compliance for United States Pharmacopeia (USP) standards for all Children's National IV Rooms and compounded sterile products (CSPs) at the Sheik Zayed campus and off-site locations
Interpret and apply USP< 797> and <800> regulatory standards for the purpose of converting workflow and practice standards to adapt to compliance
Develop, coordinate and document education and training processes for staff working in IV or anterooms to ensure complete compliance with regulatory standards for USP<797> and all aspects related to USP<800>
Functions as subject matter expert for identifying quality improvements based on gaps with compliance
Maintain and manage current, accurate documentation and records required for compliance with regulatory standards
Supervise all processes related to glove-fingertip testing, media-fill testing, and environmental monitoring sampling for employees annually
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
Provide expert knowledge in the appropriate protocols and methodologies for cleaning, disinfecting, and contamination control for all cleanroom locations
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
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
Evaluate all IV room personnel and behaviors during the process of compounding or preparing to compound sterile products for 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
Validate evidence of education, training, and documented competence of all personnel working in the IV room
Ensure pharmacy has written procedures in place to document compliance and interventions
Collaborate with other department leaders to educate staff and other providers (as needed) on SOPs and policy information on USP-797/800 standards
Develop, initiate, and oversee training tools and competencies both independently and in collaboration with other department leaders
Maintain competence and knowledge in aseptic technique, and environmental monitoring for all staff
Develop staffing plans/schedules and resources to optimize productivity and ensure quality service; scope hires, and supervise the contracting/staffing of project needs for both Children's National and third-party contractors to maintain schedules, etc.
Participate in developing architectural programs.
Work with administrative coordinator to maintain schedules, budgets, contracts, and user group communications for each project; develop agendas, office appointments, meetings, conferences, and projects.
Help design and implement efficient work systems and work groups; assume direct responsibility for all aspects of small/medium projects once design is completed.
Provide training and developmental opportunities for staff; initiate disciplinary actions when necessary.
Assist Director in managing large compliance projects.
Responsible for all aspects of construction management.
Ability to maintain all required project documentation for change orders, requests for information, construction bulletins, and other contract correspondence.
Ability to manage and control the project's overall budget, including but not limited to being able to track change order requests and contingency risk reserve assessment; ability to support the financial analyst in cash flow tracking/forecasting and grant reporting; review appropriateness and pricing for change order requests and make recommendations regarding the acceptance of such.
Ability to draft all associated project communication with contractor, design team, and departmental users; ability to write monthly project summaries for each project under direct supervision.
Ability to foster and work in a team environment (including both internal and external members) and develop a customer-focused approach to project management and problem resolution.
Maintain project logs (including RFIs, Change orders, and Bulletins) and initiate follow-up on unique or delayed items; review project initiation and control forms for adequacy and work with submitting departments to achieve satisfactory information is received.
Support and assist with the construction quality assurance supervision of other construction projects as assigned.
Responsible for on-site supervision of the contractor, quality review/oversight of construction quality, and compliance with plans and specifications.
Determine benchmarks for high productivity to determine adequate staffing.