Program QA Coordinator
Blood Center Headquarters (La Concha)
Program QA Coordinator
Hours Per Week:
GULF COAST REGIONAL BLOOD CENTER
Location: 1400 La Concha Lane in Houston, Texas 77054
TITLE/CODE: Program QA Coordinator
DEPARTMENT: Medical Services (Medical Apheresis)
SCOPE OF RESPONSIBILITY:
Reporting to the Medical Director, this position monitors and manages the quality and compliance activities as assigned, relating to Medical Services, the National Marrow Donor Program’s Donor Center and Apheresis Center, and Medical Apheresis Programs. Additionally, this role provides general Transfusion Client Services support which includes client onboarding and quarterly/annual reporting.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following; other duties may be assigned. Management retains the discretion to add to or change the duties of the position at any time.
· Maintains and monitors quality program encompassing compliance and regulatory matters, cGMP/cGTP training, competency assessment and SOP development for assigned areas.
· Serves as primary quality unit representative who will be responsible for the AC product collection quality review requirement.
· Ensures that all documents are processed in a timely manner and that donor and patient records are appropriately reviewed.
· Ensures compliance with all standards, policies, procedures and documentation requirements set forth by NMDP and other regulatory authorities.
· Recommends and implements the creation of and modifications or additions to new and existing standard operating procedures and training materials as needed.
· Coordinates review, tracking, and closure of reports of TRALI and transfusion-transmitted diseases.
· Coordinates and performs on-boarding of new transfusion service clients; maintains database and quality assurance information on all current transfusion service clients and provides client reporting.
· Schedules on-site activities for pathology residents and blood bank fellows from local academic institutions.
· Consults and collaborates with QA management in quality system activities such as root cause analysis, corrective action planning, and process improvement development.
· Maintains all records required by AABB, FDA, NMDP, and other accrediting agency standards, including audit data forms.
· Answers routine donor eligibility questions.
Must not pose a direct threat or significant risk of substantial harm to the safety or health of himself/herself or others. Must comply with all applicable safety rules and policies and be willing to report actual and potential safety violations to the appropriate supervisor or manager.
Must maintain regular and acceptable attendance at such level as is determined in The Blood Center’s sole discretion.
Full time: must be regularly available to work at least 8 hours per day, 40 hours per week, or such other days or hours per week as The Blood Center determines are necessary to meet business needs.
Overtime (applicable only to non-exempt positions)
Must be available and willing to work such overtime per day or per week as The Blood Center determines is necessary or desirable to meet business needs.
Weekend and Holidays
Must be available and willing to work such weekends and holidays as The Blood Center determines are necessary or desirable to meet its business needs.
Must occasionally be able to work at off site locations and to transport self to same.
This job has no supervisory responsibilities.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION AND EXPERIENCE:
Must have at least one year certificate from an accredited college/technical school or three years of directly related experience in lieu of education; and a minimum of 3 years’ experience in Quality Control applicable or related experience in a healthcare industry, blood banking, or cellular therapy program preferably in a CGMP/GTP environment.
CERTIFICATES, LICENSES, REGISTRATIONS:
Ability to read, analyze, and interpret governmental regulations, general business periodicals, professional journals, and technical procedures. Ability to write procedures, reports, and business correspondence. Ability to effectively present information and respond to questions from donors, clients, customers, and the general public.
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions and deal with several abstract and concrete variables. Ability to make decisions quickly on available information and to take action; to make commitments and not change decisions when challenged and to deal with emergencies when necessary; to take action in solving problems while exhibiting judgment and a realistic understanding of issues; use reason, even when dealing with emotional topics.
OTHER SKILLS AND ABILITIES:
Computer literate: Microsoft Office
Excellent customer and interpersonal communication skills, both oral and written.
Superior attention to detail and accuracy.
Ability to manage multiple projects and prioritize own work.
Flexibility for handling a demanding, irregular schedule based on organizational needs.
Ability to work independently as well as with others in a team to ensure quality donor and patient care.
Strong team-oriented, interpersonal skills are essential.
- Must be able to manage and coordinate all tasks assigned and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines.
- Excellent organizational skills and attention to detail.
POSITION DRIVING STATUS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently required to operate a computer and other office machinery and remain in a stationary position. The employee must frequently lift and/or move up to 10 pounds. Employees are required to be familiar with and abide by the team lift requirements as specified in the Safety Program.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate. The employee is occasionally exposed to blood and/or blood components, as well as any other biohazard materials. The noise level in the work environment is usually moderate.
EQUAL OPPORTUNITY EMPLOYER STATEMENT
The Blood Center is an Affirmative Action/Equal Employment Opportunity Employer. Qualified applicants for positions are considered without regard to race/ethnicity, color, religion, national origin, age, pregnancy, sex, sexual orientation, gender identity, transgender status, military status, protected veteran status, disability status, genetic testing results or any other basis or characteristic prohibited by applicable law, statute, regulation or Executive Order.