GUIDANCE ON PREPARATION OF
LABORATORY QUALITY ASSURANCE PLANS
DOCUMENT CONTROL NUMBER
EPA 910/9-92-032
U.S. ENVIRONMENTAL PROTECTION AGENCY
1200 SIXTH AVENUE
SEATTLE, WASHINGTON 98101
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TABLE OF CONTENTS
Item Page
1. Title Page 3
2. Table of Contents 5
3. Quality Assurance Policy Statement 5
4. Corporate Ethics Policy on Waste, Fraud, and Abuse 5
5. Quality Assurance Management 5
6. Administrative Organization 6
7. Personnel Qualifications 6
8. Facility Description and Capital Equipment 6
9. Preventive Maintenance 8
10. Corrective Action 8
11. Laboratory Evaluation and Audits 8
12. Quality Assurance Reports to Management 9
13. Lab Documentation and Forms 9
14. Sub-Contracting of Services 9
15. Standard Operating Procedures 9
16. Laboratory Personnel Training Record 13
References 14
Appendix A-Personnel Qualifications 15
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This document is designed to provide guidance on the preparation of
laboratory quality assurance plans. A laboratory QA plan needs to include some
of the elements from both QAMS-004 Interim Guidance for the Preparation of OA
Program Plans (1) and QAMS-005 Interim Guidance for the Preparation of OA Project
Plans (2) plus some additional topics. It is expected that laboratories that
prepare a QA plan following this guidance will produce a plan that will cover all
their operations and therefore would not produce "project specific" laboratory
QA plans unless required. It is assumed that most laboratories operate at some
specified level, i.e., parameter specific quantitation limits for a majority of
their work. The laboratory may do work on specific projects that may require
lower quantitation limits or tighter precision or accuracy goals than the lab's
normal operating basis; only in these cases would project specific QA plans be
required for those parameters that are not covered by normal laboratory
operations. The laboratory QA plan is designed to be written to cover a single
lab operating at a single location.
This guidance document is designed to be generic in nature so that all
types of labs may follow it. This would include analytical chemistry labs,
geotechnical service labs and other lab facilities. It is designed to include a
statement of QA policy, organizational structure, facility layout and equipment,
personnel qualifications, and QA/QC.
The minimum elements of the lab QA plan would include:
1. Title Page
2. Table of Contents
3. Quality Assurance Policy Statement
4. Corporate Ethics Policy on Waste, Fraud, and Abuse
5. Quality Assurance Management
6. Administrative Organization
7. Personnel Qualifications
8. Facility Description and Capital Equipment
9. Preventive Maintenance
10. Corrective Action
11. Laboratory Evaluation and Audits
12. Quality Assurance Reports to Management
13. Lab Documentation and Forms
14. Sub-Contracting of Services
15. Standard Operating Procedures
16. Laboratory Personnel Training Record
The content expected in each section is briefly described below. The lab
QA plan will be prepared in document control format. This will consist of
revision, date and page number on each page of the document.
1. Title Page
The title page will include the name and address of the lab, and dated
signature approval lines for the company's management, lab director, QA director
and other chief officers. A separate dated signature page may be used if
necessary. The lab QA plan will be signed by the chief officers to concur with
the contents of the lab QA plan and to show their commitment to provide the
resources necessary to ensure proper quality operation of the lab facility. A
suggested title page format is shown in Figure 1.
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Laboratory Quality Assurance Plan
For
Laboratory Name
Street Address
City, State ZIP Code
Phone Number
Revision
Date
Approvals:
Name:
Title:
Signature:
Name:
Title:
Signature:
Name:
Title:
Signature:
Date:
Date:
Date:
Figure 1 - Example Title Page
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2. Table of Contents
The table of contents will address each of the following elements:
Introduction - optional.
A serial listing of all the elements for a laboratory QA plan.
A listing of any appendices which are required to augment the laboratory
QA plan, it is suggested that all operational Standard Operating
Procedures (SOPs) be included as appendices and organized in some manner
that is convenient for the laboratory to distribute.
3. Quality Assurance Policy Statement
The policy statement in this section should describe the QA goals of the
laboratory and describe, in general terms, the laboratory's commitment to ensure
data are of known and documented quality.
The policy statement reflects management's commitment to QA throughout the
data generating and processing operations. All reported data must be accompanied
by a calculation of precision and accuracy, where appropriate, a statement on the
completeness, representativeness and comparability is to be included.
4. Corporate Ethics Policy on Waste. Fraud, and Abuse
A statement on/or the laboratory's policy on improper manipulation,
falsification of data, or deviations from contractual requirements shall be
included. The policy shall state how the laboratory will handle such activities
and any punitive measures the lab will take towards employees engaging in such
activities.
If data is generated for, or by, any department, agency, or entity of the
federal government, then the appropriate department's Inspector General telephone
numbers shall be included with instructions to report any allegations of fraud,
waste or abuse occurring on government projects.
The laboratory shall post it's ethics policy in a prominent place and shall
include its' policy in all Standard Operating Procedures.
5. Quality Assurance Management
The direct and ultimate responsibility for assuring data quality rests with
the line manager (e.g., CEO, lab director, etc), not the quality assurance
officer (QAO). In delegating QA responsibilities/authorities, line managers
usually divide their delegations between their subordinate line managers. The QAO
is there to provide technical support and to review and approve QA products.
This section should contain a description of the organizational entities
involved in data collection activities. An organizational chart showing reporting
lines should be provided and those specific groups responsible for data
collection or for QA/QC activities should be identified and their inter-
relationship defined. The responsibility/authority for carrying out the QA of
each group should be described in a way which clarifies the nature of and
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division of these delegations.
While it is typical for the laboratory analyst to provide the first level
of data review in the laboratory, there should be an independent reporting
channel for quality assurance/control of data. Thus if a problem arises,
corrective action may be taken through normal administrative reporting channels.
If the problem is not addressed, then an alternative channel for problem
resolution exists outside of the normal administrative reporting/supervisory
channels.
6. Administrative Organization
This section will cover the normal administrative reporting/
responsibilities of the laboratory. It will most likely be different than the QA
Management reporting structure, but should show how and where QA management
reports to the administrative management structure. QA management should be able
to independently report to the administrative management.
This section will cover the duties and responsibilities of the key section
heads in the lab and will include an organizational chart showing lines of
authority and reporting responsibilities.
7. Personnel Qualifications
A brief listing of personnel should be included. This would include name,
title, degree(s), years of experience and duties. This should be brief and
detailed resumes are not expected but could be included at the labs option.
It is expected that personnel occupying certain positions would meet the
minimal education and experience requirements stated in the Manual for the
Certification of Laboratories Analyzing Drinking Water (3), EPA's Contract
Laboratory Program Statements of Work for Inorganic or Organic Analyses (4,5),
or in any applicable regulatory requirements for those positions.
Qualifications have been established for work performed under Agency
contracts and Programs and are included in Appendix A of this guidance.
8. Facility Description and Capital Equipment
This section will have a brief description of the lab facility and layout.
Key support services for proper lab operation should be identified, i.e.,
deionized water supply system, ventilation systems, working space, equipment and
sample storage areas, etc.
A list of laboratory capital equipment at the site should be included. This
would include such items as: GC/MS, GCs, AAs, ICP, etc. If the lab instruments
have computer data systems then a listing should be included giving details on
the software and revision being used for data acquisition or manipulation.
Information to be included is type of instruments (GC, GC/MS, AA, GFAA,
etc.), manufacturer and model number, date of acquisition (year), and if
applicable, software and revision used to control instrument or data acquisition
and reduction. An example format for the capital instrument inventory is given
in Figure 2.
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Instrument Inventory
Software Date
Make Model Tvoe /Revision Identifier Installed
Type = GC, GC/MS, ICP, GFAA, AA, etc.
Identifier = Lab specific instrument identifier where multiple instruments are involved.
Figure 2 - Example layout for an instrument inventory.
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9. Preventive Maintenance
This section should include a schedule of specific routine maintenance to
be performed on capital equipment and lab support systems. A list of critical
spare parts should also be included.
10. Corrective Action
A corrective action program, which must have the capability to deal with
errors or defects at any point in the generation of data, is an essential
management tool for quality assurance/ quality control activities.
A plausible corrective action scheme must be designed to identify defects,
tally defects, trace defects to their source, plan and implement measures to
correct identified defects, maintain documentation of the results of the
corrective process until each defect is eliminated. This may be accomplished
through the use of corrective action forms.
This section should cover general corrective action procedures to be
followed if lab QA/QC criteria are not met for an analysis or project.
11. Laboratory Evaluation and Audits
Management System Reviews (MSRs) are on-site audits of an organization used
to verify the existence and to evaluate the adequacy of internal management
systems and documents necessary for the implementation of a QA program. The
primary purpose of a QA management audit is to determine the extent to which QA
is being implemented within an organization and to recommend actions which are
necessary to correct deficiencies.
Technical System Audits (TSAs) focus on the actual quality control and
environmental data collection systems. A TSA entails an examination of
calibration records, sampling and measurement procedures, general laboratory
cleanliness, support systems, equipment and facilities, maintenance and repair
records, control charts, etc. TSA auditors must be competent scientists who are
familiar with the particular technology and quality control procedures.
A Performance Evaluation (PE) is the means of evaluating the performance
of laboratory technicians and the instrumentation or analytical systems on which
they work. A PE audit is accomplished by providing PE samples containing specific
pollutants (in appropriate matrix) unknown to the technician in their
concentration and/or identity.
Data Quality Audits (DQAs) are an evaluation of the documentation
associated with data quality indicators of measurement data to verify that the
data are of known quality. The primary purpose of this type of audit is to verify
the availability of quantitative and qualitative indicators of data quality.
Availability of data quality indicators depends upon the proper collection,
interpretation, and reporting of information required to characterize the quality
of data.
This section will detail the types and frequency of all performance and
system audits to be performed in the laboratory on a routine basis. Certain
projects may specify more frequent audits and if this occurs can be addressed on
a project by project basis.
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12. Quality Assurance Reports to Management
This section will discuss the periodic reports to be sent to management as
a result of any audits or ongoing QC sample analysis. It should also discuss the
mechanism used to follow up on any corrective actions needed as the result of an
audit or continuing QC problems. This may be accomplished through periodic
reports to management using an established schedule of reports.
It is recommended that the Laboratory QA Plan be reviewed and updated, if
necessary, on an annual basis. This annual review may be accomplished through the
use of a Management System Review.
13. Lab Documentation and Forms
This section should have copies of all the routinely used forms in the lab.
Document control procedures should be discussed to explain how new forms are
generated and documented and how new forms supersede older forms.
14. Sub-Contracting of Services
Because many labs will sub-contract out services they cannot perform on a
large project, this section will discuss the general requirements for determining
when and how such sub-contracting will be done. This should include selection of
a sub-contractor, requirements to be imposed on the sub-contractor (such as
having a QA plan), audit requirements, etc.
It should be noted that there are severe limitations on sub-contracting of
services with EPA Contract Laboratory Program samples.
15. Standard Operating Procedures
Standard Operating Procedures (SOPs) are to be available for all routinely
used sampling or analytical laboratory methods. The Laboratory must maintain a
log of all SOPs in use and must maintain a file of all revisions of SOPs used in
the past. A current list of all SOPs and revision number and date must be
appended to the Laboratory QA Plan. All such methods shall be documented in
detail. Generally, simply citing a published method is not adequate for a SOP.
Published methods rarely have all the procedural details, and those that do
generally have to be modified for the applications or facilities at hand.
Suggested references for the format of SOPs are included in the reference section
of this document (6, 8). These SOPs shall be prepared in document control format.
As a minimum the following items should be included:
* Title Page
* Scope and Applications
* Definitions
* Procedures
* QC Limits
* Corrective action Procedures, Including Procedures for
Secondary Review of Information Being Generated
* Documentation Description and Example Forms
* Miscellaneous Notes and Precautions
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* References
At times certain SOPs may not cover all the above elements, especially
administrative type SOPs. In that case some other format and elements should be
developed to properly address the purpose of documenting the procedure covered
by the SOP. SOPs shall be located in an accessible placets) and copies shall be
available to all personnel needing them to perform their duties.
Once prepared, these SOPS would only have to be included in QA project
plans by reference, after being subjected to prior review and approval.
This section will be quite flexible and will include all the lab's SOPs for
all its' routine operating and analytical procedures. The following is a list of
possible SOPs and should not be considered to be all inclusive:
1. Evidentiary SOPs
1.1 Sample Identification
1.2 Chain of Custody
1.3 Sample Receiving
1.4 Sample Tracking
1.5 Laboratory Notebook Issuance and Correction Procedures
(9)
1.6 Document Numbering, Inventory and Storage
2. Sample Receipt and Storage
2.1 Sample Custody Procedure
2.2 Sample Identification Logbooks
2.3 Refrigerator Temperature Logbooks
2.4 Extract Storage Logbooks
2.5 Security Precautions
3. Sample Preparation
3.1 Reagent Purity Check Procedures and Documentation
3.2 Extraction Procedure
3.3 Extraction Bench Sheets
3.4 Extraction Logbook Maintenance
4. Glassware Cleaning
4.1 Organic Analysis Glassware Cleaning
4.2 Inorganic Analysis Glassware Cleaning
4.3 Sample Container Cleaning (if applicable)
5. Calibration (Balances)
5.1 Procedures
5.2 Frequency Requirements
5.3 Acceptance Criteria and Corrective Actions
5.4 Logbook Maintenance
6. Analytical Procedures (for each analytical System)
6.1 Instrument Performance Specifications
6.2 Instrumental Operating Conditions
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6.3 Data Acquisition System Operation
6.4 Procedures When Automatic Quantitation Algorithms Are
Overridden
6.5 QC Required Parameters
6.6 Analytical Run/Injection Logbooks
6.7 Instrumental Error Flag Descriptions and Resulting
Corrective Actions
7. Maintenance Activities (for each Analytical System)
7.1 Preventive Maintenance Schedule and Procedures
7.2 Corrective Maintenance Determination and Procedures
7.3 Maintenance Authorization
7.4 Maintenance Procedures should be included for
instrumentation and lab support systems, such as
distilled water, hoods, gas supplies, etc.
8. Analytical Standards
8.1 Standard Coding/Identification and Inventory System
8.2 Standards Preparation Logbook(s)
8.3 Standards Preparation Procedures
8.4 Procedures for Equivalency and Traceability Analyses and
Documentation
8.5 Purity Logbook (Primary Standards and Solvents)
8.6 Storage, Replacement, and Labeling Requirements
8.7 QC and Corrective Action Measures
9. Data Reduction Procedures
9.1 Data Processing Systems Operation
9.2 Outlier Identification Methods
9.3 Identification of Data Requiring Corrective Action
9.4 Reporting Format and/or Forms for Each Operation
10. Documentation Policy/Procedures
10.1 Laboratory/Analyst's Notebook Policy, including Review
Policy
10.2 Organization and Storage Procedures for Raw Data and
Reports
10.3 Data Inventory Procedures, including Review Policy
11. Data Validation/ Self Inspection Procedures
11.1 Data Flow and Chain of Command for Data Review
11.2 Procedures for Measuring Precision and Accuracy
11.3 Evaluation Parameters for Identifying Systematic Errors
11.4 Procedures to Assure that Hardcopy and Electronic
Deliverables are Complete and Compliant with Client
Requirements
11.5 Procedures to Assure that Hardcopy Deliverables are in
Agreement With Electronic Deliverables
11.6 Demonstration of Internal QA Inspection Procedures
(demonstrated by supervisory sign-off of personal
notebooks, internal PE samples, etc.)
11.7 Frequency and types of internal audits (e.g., random,
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quarterly, spot checks, perceived trouble areas)
11.8 Demonstration of problem identification-corrective
actions and resumption of analytical processing,
Sequence resulting from internal audit (i.e., QA
feedback).
11.9 Documentation of audit reports (internal and external),
audit responses, corrective actions, etc.
12. Data Management and Handling
12.1 Procedures for controlling and estimating data entry
errors.
12.2 Procedures for reviewing changes for data and
deliverables and ensuring traceability of updates.
12.3 Lifecycle management procedures for testing, modifying,
and implementing changes to existing computing systems
including hardware, software, and documentation or
installing new systems.
12.4 Database security, backup, and archival procedures
including recovery from system failure.
12.5 System maintenance procedures and response times.
12.6 Individual(s) responsible for system operation,
maintenance, data integrity and security.
12.7 Specifications for staff training procedures.
13. Quality Assurance and Quality Control
13.1 Frequency and types of QC samples used in analysis
methods.
13.2 Frequency and types of QC samples taken to determine
performance of lab support facilities, i.e., deionized
water supplies, etc.
13.3 Use of control charts or other data analysis procedures
to evaluate analytical method quality control
information.
13.4 Corrective action procedures to be taken when QC
information indicates a problem or deviation.
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16. Laboratory Personnel Training Record
The laboratory shall develop and document procedures for training each
analyst in all methods that each analyst is conducting. The training method and
period shall be documented in an SOP(s). Training records shall be maintained
by the laboratory for each analyst. At a minimum, the records shall include the
analyst's name, the method(s) and date(s) for which the analyst has completed
training, the person(s) (supervisor) certifying completion of each training
session, the date(s) recertification training is needed and the date(s)
recertification was completed (if appropriate). Only analysts who have completed
training may conduct analytical methods independently. An analyst in training
must be directly supervised by an analyst who has completed training.
The training record may also include additional educational courses,
professional seminars attended, in-house training courses, etc.
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References
1. EPA-600/8-83-024, Guidelines and Specifications for Preparing Quality
Assurance Program Plans, QAMS-004/80, EPA, June 1983.
2. Interim Guidelines and Specifications for Preparing Quality Assurance Project
Plans, QAMS-005/80, EPA, December 29, 1980.
3. EPA/570/9-90/008, Manual for the Certification of Laboratories Analyzing
Drinking Water: Criteria and Procedures Quality Assurance, 3rd Ed., EPA, April
1990.
4. U.S. EPA Contract Laboratory Program Statement of Work for Inorganic Analysis,
Multi-Media Multi-Concentration, Document Number ILM01.0.
5. U.S. EPA Contract Laboratory Program Statement of Work for Organic Analysis,
Multi-Media Multi-Concentration, Document Number OLM01.0.
6. Dux, James P., Handbook of Quality Assurance For The Analytical Chemistry
Laboratory, Van Nostrand Reinhold Company (New York), 1986.
7. Taylor, John Keenan, Quality Assurance of Chemical Measurements, Lewis
Publishers, 1987.
8. EPA-600/4-82-057, Methods for Organic Chemical Analysis of Municipal and
industrial Wastewater, EPA, July 1982.
9. Kanare, Howard M., Writing the Laboratory Notebook, American Chemical Society,
Washington, D.C., 1985.
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Appendix A-Personnel Qualifications
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The following qualifications have been established for work performed under
Agency contracts or Programs and are recommended for equivalent positions and
work.
Inorganic Laboratory Supervisor
Education: Minimum of a Bachelor's degree in chemistry or any
scientific/engineering discipline.
Experience: Minimum of three years of laboratory experience,
including at least one year in a supervisory position.
Quality Assurance Officer
Education: Minimum of a Bachelor's degree in chemistry or any
scientific/engineering discipline.
Experience: Minimum of three years of laboratory experience,
including at least one year of applied experience with QA principles
and practices in an analytical laboratory.
Systems Manager
Education: Minimum of a Bachelor's degree with four or more
intermediate courses in programming, information management,
database management systems, or systems requirements analysis.
Experience: Minimum of three years of experience in data or systems
management or programming including one year experience with
software being utilized for data management and generation of
deliverables.
Programmer Analyst
Education: Minimum of a Bachelor's degree with four or more
intermediate courses in programming, information management,
database management systems, or systems requirements analysis.
Experience: Minimum of two years of experience in systems or
application programming including one year experience with software
being utilized for data management and generation of deliverables.
ICP Spectroscopist
Education: Minimum of a Bachelor's degree in chemistry or any
scientific/engineering discipline. Specialized training in ICP
spectroscopy.
Experience: Minimum of two years of applied experience with ICP
analysis of environmental samples.
ICP Operator
Education: Minimum of a Bachelor's degree in chemistry or any
scientific/engineering discipline with one year of experience in
operating or maintaining ICP instrumentation, or, in lieu of the
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educational requirement, three additional years of experience in
operating and maintaining ICP instrumentation.
Atomic Absorption Operator
Education: Minimum of a Bachelor's degree in chemistry or any
scientific/engineering discipline with one year of experience in
operating or maintaining AA instrumentation, or, in lieu of the
educational requirement, three additional years of experience in
operating and maintaining AA instrumentation, including graphite
furnace, flame, and cold vapor techniques.
Inorganic Sample Preparation Specialist
Education: Minimum of a high school diploma and a college level
course in general chemistry or equivalent.
Experience: Minimum of one year of experience in sample preparation
in an analytical laboratory. If microwave digestions are performed
an additional six months of experience with microwave digestions is
required.
Classical Techniques Analysts
Education: Minimum of a Bachelor's degree in chemistry or any
scientific/engineering discipline.
Experience: Minimum of one year experience with classical chemistry
laboratory procedures, in conjunction with the educational
qualifications; or, in lieu of educational requirement, two years of
additional equivalent experience.
GC/MS Laboratory Supervisor
Education: Minimum of a Bachelor's degree in chemistry or any
scientific/engineering discipline.
Experience: Minimum of three years of laboratory experience,
including at least one year in a supervisory position.
GC/EC Laboratory Supervisor
Education: Minimum of a Bachelor's degree in chemistry or any
scientific/engineering discipline.
Experience: Minimum of three years of laboratory experience,
including at least one year in a supervisory position.
Sample Preparation Laboratory Supervisor
Education: Minimum of a Bachelor's degree in chemistry or any
scientific/engineering discipline.
Experience: Minimum of three years of laboratory experience,
including at least one year in a supervisory position.
GC/MS Operator
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Education: Minimum of a Bachelor's degree in chemistry or any
scientific/engineering discipline. Training courses in mass spectral
interpretation.
Experience: Minimum of two years of experience in mass spectral
interpretation.
GC/EC Operator
Education: Minimum of a Bachelor's degree in chemistry or any
scientific/engineering discipline.
Experience: Minimum of one year of experience in operating and
maintaining GC/EC with a Bachelor's degree or, in lieu of the
Bachelor's degree, three years of experience in operating and
maintaining the GC/EC and interpreting GC/EC data.
Pesticide Residue Analysis Expert
Education: Minimum of a Bachelor's degree in chemistry or any
scientific/engineering discipline.
Experience: Minimum of two years of experience in operating and
maintaining GC and interpreting GC chromatograms.
Extraction/Concentration Expert
Education: Minimum of a high school diploma and a college level
course in general chemistry or equivalent.
Experience: Minimum of one year of experience in sample
extraction/concentration.
Microbiology Supervisor
Education: Minimum of a Bachelor's degree in science.
Experience: Minimum of two weeks training from a Federal agency,
state agency, or academic institution in microbiological analysis of
drinking water.
Microbiology Analyst
Education: Minimum of a high school education. Training in
microbiological analysis of drinking water, acceptable to the state
(or EPA for nonprimacy states), plus a minimum of 30 days on-the-job
training.
Experience: At least one year of bench experience in sanitary,
water, milk, or food microbiology.
Radiochemistry Supervisor
Education: Minimum of a Bachelor's degree, or its equivalent.
Experience: Minimum of five years of experience.
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Radiochemistry Analyst
Education: Minimum of a Bachelor's degree in chemistry,
radiochemistry, radioisotope technology, or equivalent.
Experience: Minimum of one year of appropriate experience in
radiation measurements and radiochemical procedures.
Radiochemistry Technician
Education: Minimum of a high school diploma or its equivalent, plus
specialized training in standards and sample preparation, instrument
calibration, calculations, and data handling.
Experience: Minimum of six months on-the-job.
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