Clinical Laboratory Scientist (Quality Manager) (EDRP Authorized)

Clarification from the agency

Open to permanent Department of Veteran Affairs employees, permanent Federal employees of other Agencies, and all US Citizens. NOTE: The 2-page Resume requirement does not apply to this position. For more information, refer to Required Documents below.

This position is in the Pathology & Laboratory Medicine Service in the Blood Bank section in Temple, Texas. A Clinical Laboratory Scientist (Quality Manager) facilitates team processes by working in collaboration with team members to ensure that tasks, priorities, goals, needs, and achievements are coordinated with management. Provides authoritative consultative services to management at all levels of the organization as it applies to quality management in a clinical laboratory setting. Maintains a laboratory performance improvement program and ensures monitoring of components and customer feedback. Interacts with management officials and organizations involved in inter-laboratory quality assurance and proficiency testing.

Major duties include, but not limited to:

• Applies policies, precedents, regulatory, licensing, and accrediting requirements to establish and monitor appropriate reference laboratories utilized at CTX.
• Assists supervisor in ensuring compliance with rules and regulations of assorted regulatory agencies such as CAP, FDA, AABB, The Joint Commission, and OSHA.
• Coordinates quality control activities and proficiency testing program with the supervisor.
• Research qualitative and quantitative methods. Performs statistical analysis on quality control and quality assurance monitors.
• Identifies, defines, and resolves issues associated with complex aspects of the collected data
• Provides authoritative representation and interaction with management officials, test reagent and instrumentation manufacturers, and with organizations involved in inter-laboratory quality assurance and proficiency testing.
• Serves as a primary source of information for maintaining current instrumentation.
• Evaluates new and evolving developments in laboratory instrumentation and automation.
• Prepares procedure manuals and reports, maintains records, SDS, supplies/inventory, student activities, and administrative information.
• Prepares and presents work-related information to supervisor.
• Coordinates employee training in the methods and techniques of the appropriate laboratory areas.
• Provides administrative support as needed to include file maintenance and timekeeping duties.
• Develops and updates technical policies and procedure manuals.
• Works with laboratory COR to validate invoices for the section to ensure accurate and timely payments.
• Maintains effective interdepartmental relations with other services to accomplish medical center goals.
• Ensures monthly Quality indicators, data spreadsheets, tracking/trending analysis of quality data, and resolution of workgroup issue tasks are performed timely.
• Maintains a laboratory quality improvement system and ensures monitoring of components and customer feedback.

Total Rewards of a Allied Health Professional

Work Schedule: Monday - Friday; 7:30am - 4:15pm; may include occasional on call
Telework: Not Available
Virtual: This is not a virtual position.
Recruitment Incentive (Sign-on Bonus): Not Authorized
Permanent Change of Station (PCS): Not Authorized
Permanent Change of Station (Relocation Assistance): Not Authorized
EDRP Authorized: Former EDRP participants ineligible to apply for incentive. Contact VISN17EDRP2@va.gov, the EDRP Coordinator for questions/assistance. Learn more
Pay: Competitive salary and regular salary increases
Paid Time Off: 37-50 days of annual paid time offer per year (13-26 days of annual leave, 13 days of sick leave, 11 paid Federal holidays per year)
Parental Leave: After 12 months of employment, up to 12 weeks of paid parental leave in connection with the birth, adoption, or foster care placement of a child.
Child Care Subsidy: After 60 days of employment, full time employees with a total family income below $144,000 may be eligible for a childcare subsidy up to 25% of total eligible childcare costs for eligible children up to the monthly maximum of $416.66.
Retirement: Traditional federal pension (5 years vesting) and federal 401K with up to 5% in contributions by VA
Insurance: Federal health/vision/dental/term life/long-term care (many federal insurance programs can be carried into retirement)
Functional Statement #: 53640-F

Conditions of employment

• You must be a U.S. Citizen to apply for this job.
• All applicants tentatively selected for VA employment in a testing designated position are subject to urinalysis to screen for illegal drug use prior to appointment. Applicants who refuse to be tested will be denied employment with VA.
• Selective Service Registration is required for males born after 12/31/1959.
• Must be proficient in written and spoken English.
• Subject to background/security investigation.
• Selected applicants will be required to complete an online onboarding process. Acceptable form(s) of identification will be required to complete pre-employment requirements (https://www.uscis.gov/i-9-central/form-i-9-acceptable-documents). Effective May 7, 2025, driver's licenses or state-issued identification cards that are not REAL ID compliant cannot be utilized as an acceptable form of identification for employment.
• Participation in the seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP).
• Complete all application requirements detailed in the "Required Documents" section of this announcement.

As a condition of employment for accepting this position, you will be required to serve a 1 or 2-year trial period during which we will evaluate your fitness and whether your continued employment advances the public interest. In determining if your employment advances the public interest, we may consider:

• your performance and conduct;
• the needs and interests of the agency;
• whether your continued employment would advance organizational goals of the agency or the Government; and
• whether your continued employment would advance the efficiency of the Federal service.

Upon completion of your trial period, your employment will be terminated unless you receive certification, in writing, that your continued employment advances the public interest.

Qualifications

Basic Requirements:

• Citizenship. Be a citizen of the United States (U.S.). Non-citizens may be appointed when it is not possible to recruit qualified citizens in accordance with 38 U.S.C. § 7407(a).
• Education. A bachelor's degree or higher from an accredited college or university.
• Certification. Candidates must meet one of the certification options below.
  • (a) Generalist certification as an MLS given by ASCP BOC or AMT.
  • (b) Generalist certification as an MT given by ASCP BOR or AMT.
  • (c) Categorical certification or Specialist certification by ASCP or AMT. NOTE: Categorical and specialist certifications are not acceptable for CLS Generalist positions or lab sections unrelated to the categorical or specialist certification held. Categorical or specialist certifications are acceptable for higher-graded positions within the relevant lab section or one of the non-section specific assignments (including, Ancillary Testing Coordinator, Education Coordinator, Laboratory Information Manager, Quality Manager, Laboratory Manager, Regional Technical Specialist, National Quality and Compliance Agent, Regional Program Manager, Regional Director, Laboratory Director, or National Quality and Compliance Officer).
• Foreign Education. To be creditable, education completed outside the U.S. must be deemed at least equivalent to that gained in a conventional U.S. program by a private organization specializing in the interpretation of foreign educational credentials. Graduates of foreign baccalaureate degree programs meet the educational requirements if they meet either of the following:
  • (1) Foreign transcripts are evaluated by an acceptable evaluation agency, and the degree is found to be equivalent to a NAACLS-approved U.S. clinical laboratory science degree program. OR
  • (2) The applicant submits a letter from ASCP BOC or AMT stating the individual is eligible to take the certification examination.
  • NOTE: Possession of a certification identified above automatically determines the foreign education as creditable and no further documentation or proof of equivalency is needed.
• English Language Proficiency. Candidates must be proficient in spoken and written English in accordance with 38 U.S.C. § 7403 (f).

May qualify based on being covered by the Grandfathering Provision as described in the VA Qualification Standard for this occupation (only applicable to current VHA employees who are in this occupation and meet the criteria).

Grade Determinations: In addition to the basic requirements for employment, candidates must meet the following grade-determining criteria for placement at grade levels specified.

Clinical Laboratory Scientist (Quality Manager), GS-12

Experience. 1 year of creditable experience equivalent to the next lower grade level (GS-11) is required for this GS-12 assignment. Experience includes independently carrying out the day-to-day operations in the laboratory. Experience includes but not limited to; independently performing advanced quality management and regulatory compliance functions in the clinical laboratory. Serve as a consultant, facilitator, trainer, and technical advisor to ensure compliance with accreditation and regulatory standards. Ensure continuous readiness, supports performance improvement and patient safety programs, and maintains the laboratory's quality improvement program. Develop, implement, and review quality management policies; monitors key quality indicators and customer feedback; and collaborate with inter-laboratory quality assurance and proficiency testing programs. Identifies areas needing improvement, creates action plans, implements changes, and tracks outcomes. Apply statistical analysis, evaluating and implementing new laboratory techniques and validation plans, and ensuring proper quality control and quality assurance practices.

Knowledge, Skills, and Abilities. In addition to the experience or education above, the candidate must demonstrate the following KSAs:

1. Knowledge of the concepts, principles, and practices of medical technology sufficient to perform the full range of duties involved in planning, coordinating, and evaluating laboratory services.
2. Knowledge of accrediting agencies and regulatory requirements pertaining to laboratory operations.
3. Knowledge of laboratory operations and relationships to the organization.
4. Skill in applying laboratory quality control/assurance policies, procedures, and principles and safety practices and regulations.
5. Ability to apply quality management performance improvement principles, methodology, and processes to develop and manage a clinical laboratory quality management program.
6. Ability to apply statistical evaluation and analysis to quality assurance data and implement corrective actions when indicated.

Preferred Experience:

• 5 years Regulatory and Quality Assurance experience including: Direct experience preparing for inspections (AABB, FDA, TJC, CAP), Document control and compliance, Quality Management Systems (QMS), and QA/Risk Management.
• 5 years Technical Blood Bank Expertise including: Advanced Immunohematology knowledge and experience, Blood Bank automation and technology (LIS), Inventory Management, and Therapeutic Phlebotomy.
• 3 years Leadership and Project Management including:
  Supervisory/Managerial Roles (MLS/MT Lead), Process Improvement, Training and Competency, and Project Management.
• Professional certification specializing in Blood Banking and Transfusion Medicine: Technologist in Blood Banking (BB) or Specialist in Blood Banking (SBB) is highly preferred

Reference: For more information on this qualification standard, please visit https://www.va.gov/ohrm/QualificationStandards/.

The full performance level of this vacancy is GS-12.

Physical Requirements: The work is sedentary. Some work may require movement between offices, hospitals, warehouses, and similar areas for meetings and to conduct work. Work may also require walking/standing, in conjunctions with travel to and attendance at meetings and/or conferences away from the work site. Incumbent may carry and lift light items weighing less than 15 pounds. And will not require a pre-placement examination.

How you will be evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE MAY NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Your application, resume, C.V., and/or supporting documentation will be verified. Please follow all instructions carefully. Errors or omissions may affect consideration for employment.

Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religions; spiritual; community; student; social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.

The Department of Veterans Affairs performs pre-employment reference checks as an assessment method used in the hiring process to verify information provided by a candidate (e.g., on resume or during interview or hiring process); gain additional knowledge regarding a candidate's abilities; and assist a hiring manager with making a final selection for a position.

It is the policy of the VA to not deny employment to those that have faced financial hardships or periods of unemployment.

Veterans and Transitioning Service Members: Please visit the VA for Vets site for career-search tools for Veterans seeking employment at VA, career development services for our existing Veterans, and coaching and reintegration support for military service members.

To apply for this position, you must provide a complete Application Package which includes:

• Resume

Special Note for Applications: To complete your application, please use the following link https://vacareers.va.gov/wp-content/uploads/sites/5/Resume.docx to download the standard Clinical Resume Document. This one-page document does not need to be modified and must be uploaded into the two-page restricted 'Resume' document upload field.

Your full resume/CV may be uploaded without page limitation into the 'Other' document upload field.



The following documents are accepted, and may be required if applicable to your eligibility and/or qualifications for this position. Please ensure you have included all documents required for your application, such as a copy of your transcript (if using education to qualify), SF-50's (current/former Federal employees), etc.

• Cover Letter
• DD-214/ Statement of Service
• Disability Letter (Schedule A)
• Disability Letter (VA)
• License
• Other (1)
• PCS Orders
• Performance Appraisal
• Professional Certification
• Resume
• Separation Notice (RIF)
• SF-15
• SF-50/ Notification of Personnel Action
• Transcript

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