32 Quality Assurance Specialist Jobs in Albuquerque, NM
US Veterans Health Administration is Hiring a Quality Assurance Specialist Near Albuquerque, NM
Duties
***THIS IS NOT A VIRTUAL POSITION, YOU MUST LIVE WITHIN OR BE WILLING TO RELOCATE WITHIN A COMMUTABLE DISTANCE OF THE DUTY LOCATION***
This position involves a multi-grade career ladder. The major duties listed below represent the full performance level of GS-11. At the GS-09 grade level, you will perform assignments of a more limited scope and with less independence. You will progressively acquire the background necessary to perform at the full performance level of GS-11. Promotion is at the discretion of the supervisor and is contingent upon satisfactory performance, availability of higher-level work, and availability of funds.
Duties will include but may not be limited to the following:
- Plans, develops, implements, and administers a wide variety of quality assurance management systems and procedures to support clinical trials for the inspection, storage, handling, manufacturing and packaging of pharmaceuticals and medical devices supporting complex national clinical trials and research programs.
- Develops, implements, and assures effective quality control procedures customized to every study, by identifying, proofing, measuring, and analyzing customer requirements in relation to established procedures to determine adequacy, reliability, and validation of processes, to promote process and product quality, and ensure continuous process improvement.
- Develops, implements, and maintains Master Production Records as to the overall specifications for the quality of every drug and medical device used for each clinical trial. Develops sampling plans and calculates required assay and retained sample needs to support stability and release protocols.
- Approves label designs to ensure conformance to cGMP regulations.
- Leads Process Action Teams (PATs); coordinates and promotes technical quality control (QC) functions and performs quality assurance (QA) operations throughout the facility to ensure that adequate quality provisions are planned, developed, and implemented.
- Interfaces with suppliers, production staff and customers to select, analyze, and audit various processes and identify methodologies for process improvement to enhance customer satisfaction and ensure successful completion of clinical trials.
- Serves as a technical expert in FDA regulatory requirements for drugs and medical devices.
- Works with study team members to establish drug assay specifications, quality metrics and product acceptance standards for cGMP compliance.
- Communicates with key officials, managers, contractors, and other individuals within and outside the agency concerning quality matters or investigations, and to seek guidance for establishing acceptance standards or critical quality parameters of drugs or devices.
- Provides informal and formal guidance and instruction to production personnel and contractors, regarding deficiency corrections, inadequate production performance, and other nonconforming product improvement and disposal.
- Mentors and assists in the training of other QC personnel, and in providing quality control, procedural and cGMP training to all staff.
- Performs other duties as assigned.
Recruitment & Relocation Incentives: Not authorized
Critical Skills Incentive (CSI): Not approved
Telework: VA supports the use of telework as a way to help attract and retain talented individuals in public service, increase worker productivity, and better prepare the agency to operate during emergencies. This position may be authorized for telework. Telework eligibility will be discussed during the interview process.
Requirements
Conditions of Employment
- You must be a U.S. Citizen to apply for this job
- Selective Service Registration is required for males born after 12/31/1959
- You may be required to serve a probationary period
- Subject to background/security investigation
- Selected applicants will be required to complete an online onboarding process
- Participation in the seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP)
- Participation in the Coronavirus Disease 2019 (COVID-19) vaccination program is a requirement for all Veterans Health Administration Health Care Personnel (HCP) - See "Additional Information" below for details.
Qualifications
SPECIALIZED EXPERIENCE: Possess at least one (1) year of specialized experience equivalent to the next lower grade level of (GS-7) in Federal service. Specialized experience that demonstrated a practical knowledge in monitoring, controlling, or maintaining the quality of products or services in quality assurance, procurement, inspection, production, or related areas. Examples include: Reviewing production activities and capabilities in light of contract quality requirements; Reviewing written quality or inspection procedures for adequacy, and evaluating the implementation and effectiveness of quality/inspection systems, including sampling plans; Analyzing quality data to detect unsatisfactory trends or weaknesses in the quality/inspection system; Verifying by test or inspection, using sampling inspection or intensive product inspection techniques, that products comply with requirements prior to acceptance; Identifying inadequacies and requesting corrective action; Computing data, summarizing results, and preparing reports or charts depicting pertinent relationships using statistical methods; Investigating customer complaints and deficiency reports, and providing identification of causes to appropriate authorities; Reading, interpreting, and applying technical data such as blueprints, engineering drawings, product specifications, or technical manuals; Reviewing and evaluating supply systems operations and procedures through periodic audits and surveillance inspections. OR
EDUCATION: Possess a master's or equivalent graduate degree or 2 full years of progressively higher level graduate education leading to such a degree or LL.B. or J.D., if related. Graduate Education: Major study - quality assurance, statistics, mathematics, production management, industrial management, computer science, engineering, engineering technology, physical sciences, textiles, or other fields related to the position. NOTE: One year of full-time graduate education is considered to be the number of credit hours that the school attended has determined to represent 1 year of full-time study. If that information cannot be obtained from the school, 18 semester hours should be considered as satisfying the 1 year of full-time study requirement. (TRANSCRIPTS REQUIRED) OR
COMBINATION OF EDUCATION AND SPECIALIZED EXPERIENCE: Possess a Combinations of successfully completed post-high school education and experience may be used to meet total qualification requirements for the grade levels. To be computed by first determining the total qualifying experience as a percentage of the experience required for the grade level; then determining the education as a percentage of the education required for the grade level; and then adding the two percentages. The total percentages must equal at least 100 percent to qualify for the grade level. Only graduate education in excess of the amount required for the next lower grade level may be used to qualify applicants for positions at grade GS-9. (TRANSCRIPTS REQUIRED)
For GS-11:
SPECIALIZED EXPERIENCE: Possess at least one (1) year of specialized experience equivalent to the next lower grade level of GS-9 in Federal service. Specialized experience that demonstrated a practical knowledge in monitoring, controlling, or maintaining the quality of products or services in quality assurance, procurement, inspection, production, or related areas. Examples include: Reviewing production activities and capabilities in light of contract quality requirements; Reviewing written quality or inspection procedures for adequacy, and evaluating the implementation and effectiveness of quality/inspection systems, including sampling plans; Analyzing quality data to detect unsatisfactory trends or weaknesses in the quality/inspection system; Verifying by test or inspection, using sampling inspection or intensive product inspection techniques, that products comply with requirements prior to acceptance; Identifying inadequacies and requesting corrective action; Computing data, summarizing results, and preparing reports or charts depicting pertinent relationships using statistical methods; Investigating customer complaints and deficiency reports, and providing identification of causes to appropriate authorities; Reading, interpreting, and applying technical data such as blueprints, engineering drawings, product specifications, or technical manuals; Reviewing and evaluating supply systems operations and procedures through periodic audits and surveillance inspections. OR
EDUCATION: Possess a Ph.D. or equivalent doctoral degree or 3 full years of progressively higher level graduate education leading to such a degree or LL.M., if related. Graduate Education: Major study - quality assurance, statistics, mathematics, production management, industrial management, computer science, engineering, engineering technology, physical sciences, textiles, or other fields related to the position. NOTE: One year of full-time graduate education is considered to be the number of credit hours that the school attended has determined to represent 1 year of full-time study. If that information cannot be obtained from the school, 18 semester hours should be considered as satisfying the 1 year of full-time study requirement. (TRANSCRIPTS REQUIRED) OR
COMBINATION OF EDUCATION AND SPECIALIZED EXPERIENCE: Possess a Combination of successfully completed post-high school education and experience may be used to meet total qualification requirements for the grade levels. To compute by first determining the total qualifying experience as a percentage of the experience required for the grade level; then determining the education as a percentage of the education required for the grade level; and then adding the two percentages. The total percentages must equal at least 100 percent to qualify for the grade level. Only graduate education in excess of the amount required for the next lower grade level may be used to qualify applicants for positions at grade GS-11. (TRANSCRIPTS REQUIRED)
This position includes two (2) Selective Placement Factors (skill, knowledge, ability or other worker characteristic basic to - and essential for - satisfactory performance of the job). Selective Placement Factors are a prerequisite to appointment and represent minimum requirements for a position. Applicants who do not meet it are ineligible for further consideration.
The Selective Placement Factor for this position is:
1. I Possess knowledge of the unique requirements of current Good Manufacturing Practices (cGMP).
2. I possess and knowledge of multiple standards and regulations governing healthcare clinical research.
You will be rated on the following Competencies as part of the assessment questionnaire for this position:
- Customer Service
- Manufacturing
- Production and Processing
- Quality Management
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; religious; 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.
Education
For more information on these qualification standards, please visit the United States Office of Personnel Management's website at https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/.
Physical Requirements: The work requires the occasional lifting up to 401bs., climbing on ladders, the use of pallet jacks and other material handling equipment (MHE), and other activities related to a warehouse environment.
IMPORTANT: A transcript must be submitted with your application if you are basing all or part of your qualifications on education.
NOTE: Only education or degrees recognized by the U.S. Department of Education from accredited colleges, universities, schools, or institutions may be used to qualify for Federal employment. You can verify your education here: http://ope.ed.gov/accreditation/. If you are using foreign education to meet qualification requirements, you must send a Certificate of Foreign Equivalency with your transcript in order to receive credit for that education. For further information, visit: Recognition of Foreign Qualifications | International Affairs Office (ed.gov).
Additional information
This job opportunity announcement may be used to fill additional vacancies.
If you are unable to apply online or need an alternate method to submit documents, please reach out to the Agency Contact listed in this Job Opportunity Announcement.
Under the Fair Chance to Compete Act, the Department of Veterans Affairs prohibits requesting an applicant's criminal history prior to accepting a tentative job offer (TJO). Please visit the Human Resources and Administration/Operations, Security, and Preparedness (HRA/OSP), va.gov/EMPLOYEE/docs/The-Fair-Chance-to-Compete-Act.pdf for more information.
Benefits
A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
Review our benefits
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
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 WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. If your resume does not support your questionnaire answers, we will not allow credit for your response(s).
Your responses to the assessment questionnaire will be reviewed along with the information provided in your resume and supporting documentation to determine if you are qualified for the position. If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your qualifications and or experience, your rating may be lowered and/or you may lose consideration for this position. Please follow all instructions carefully. Errors or omissions may affect your eligibility.
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.
Candidates who apply under All U.S. Citizens announcements will be rated and ranked using Category Rating procedures. Qualified candidates will be assigned to a quality category. The categories are defined as follows:
- Best qualified - applicants possessing experience that substantially exceeds the minimum qualifications of the position including all selective factors, and who are highly proficient in all requirements of the job and can perform effectively in the position;
- Highly qualified - applicants possessing experience that exceeds the minimum qualifications of the position including all selective factors, and who are proficient in most of the requirements of the job;
- Well qualified - applicants possessing experience that meets the minimum qualifications of the position including all selective factors, and who are proficient in some, but not all, of the requirements of the job; and
- Qualified - applicants possessing experience and/or education that meets the minimum qualifications of the position including all selective factors.
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.
Benefits
A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
Review our benefits
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
Required Documents
As a new or existing federal employee, you and your family may have access to a range of benefits. Your benefits depend on the type of position you have - whether you're a permanent, part-time, temporary or an intermittent employee. You may be eligible for the following benefits, however, check with your agency to make sure you're eligible under their policies.
IMPORTANT: Please ensure your resume include up-to-date contact information (phone number(s), email address(s), etc.)
To apply for this position, you must provide a complete Application Package which includes:- Resume
- Cover Letter
- DD-214/ Statement of Service
- Disability Letter (VA)
- Other (1)
- Other (2)
- Resume
- Separation Notice (RIF)
- SF-15
- SF-50/ Notification of Personnel Action
- Transcript
If you are relying on your education to meet qualification requirements:
Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education.
Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.
How to Apply
All applicants are encouraged to apply online. To apply for this position, you must complete the questionnaire and submit the documentation specified in the Required Documents section below. The complete application package must be submitted by 11:59 PM (ET) on 08/06/2024 to receive consideration. To preview the questionnaire click https://apply.usastaffing.gov/ViewQuestionnaire/12495829.
To verify your application is complete, log into your USAJobs account, https://my.usajobs.gov/Account/Login, select the Application Status link and then select the more information link for this position. The Application page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Your uploaded documents may take several hours to clear the virus scan process. To return to an incomplete application, log into your USA JOBS account and click Update Application in the vacancy announcement. You must re-select your resume and/or other documents from your USA JOBS account or your application will be incomplete.- To begin, click Apply Online to create a USA JOBS account or log in to your existing account. Follow the prompts to select your USA JOBS resume and/or other supporting documents and complete the occupational questionnaire.
- Click Submit My Answers to submit your application package. NOTE: It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date.
Receiving Service Credit for Earning Annual (Vacation) Leave: Federal Employees earn annual leave at a rate (4, 6 or 8 hours per pay period) which is based on the number of years they have served as a Federal employee. Selected applicants may qualify for credit toward annual leave accrual, based on prior work experience or military service experience. This credited service can be used in determining the rate at which they earn annual leave. Such credit must be requested and approved prior to the appointment date and is not guaranteed.
Special Employment Consideration: VA encourages persons with disabilities to apply, including those eligible for hiring under 5 CFR 213.3102(u), Schedule A, Appointment of persons with disabilities (i.e., intellectual disabilities, severe physical disabilities, or psychiatric disabilities), and/or disabled veterans with a compensable service-connected disability of 30% or more. For more information on how to apply using this appointment authority via the Selective Placement Coordinator within the office, contact the facility Human Resources Department at (202) 020-2020.
The Interagency Career Transition Assistance Plan (ICTAP) and Career Transition Assistance Plan (CTAP) provide eligible displaced Federal competitive service employees with selection priority over other candidates for competitive service vacancies. To be qualified you must submit appropriate documentation and be found well-qualified (have a final rating of 85 or more before any Veterans preference points) for this vacancy. Information about ICTAP and CTAP eligibility is on OPM's Career Transition Resources website at http://www.opm.gov/policy-data-oversight/workforce-restructuring/employee-guide-to-career-transition/.Agency contact information
VHA National Recruitment CenterPhone(844)456-5208EmailVHANationalRecruitmentCenter@va.govAddressAlbuquerque ORD VISN 22
1501 San Pedro Drive, Southeast
Albuquerque, NM 87108
USNext steps
Once your online application is submitted you will receive a confirmation notification by email. After the vacancy announcement closes, we will review applications per Category Rating procedures to ensure qualification and eligibility requirements are met. After the review is complete, a referral certificate(s) is issued and applicants will be notified of their status by email. Referred applicants will be notified as such and may be contacted directly by the hiring office for an interview. All referred applicants receive a final notification once a selection decision has been made.
You may check the status of your application at any time by logging into your USA Jobs account and clicking on Applications. Information regarding your application status can be found in the USAJobs Help Center.
NOTE: Participation in the seasonal influenza program is a condition of employment and a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). It is a requirement that all HCP to receive annual seasonal influenza vaccination or obtain an exemption for medical or religious reasons. Wearing a face mask is required when an exemption to the influenza vaccination has been granted. HCP in violation of this directive may face disciplinary action up to and including removal from federal service. HCP are individuals who, during the influenza season, work in VHA locations or who come into contact with VA patients or other HCP as part of their duties. VHA locations include, but are not limited to, VA hospitals and associated clinics, community living centers (CLCs), community-based outpatient clinics (CBOCs), domiciliary units, Vet centers and VA-leased medical facilities. HCP include all VA licensed and unlicensed, clinical and administrative, remote and onsite, paid and without compensation, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, researchers, volunteers and health professions trainees (HPTs) who are expected to perform any or all of their work at these facilities. HPTs may be paid or unpaid and include residents, interns, fellows and students. HCP also includes VHA personnel providing home-based care to Veterans and drivers and other personnel whose duties put them in contact with patients outside VA medical facilities.Fair and Transparent
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
- Criminal history inquiries
- Equal Employment Opportunity (EEO) Policy
- Financial suitability
- New employee probationary period
- Privacy Act
- Reasonable accommodation policy
- Selective Service
- Signature and false statements
- Social security number request
Required Documents
IMPORTANT: Please ensure your resume include up-to-date contact information (phone number(s), email address(s), etc.)
To apply for this position, you must provide a complete Application Package which includes:
- Resume
- Cover Letter
- DD-214/ Statement of Service
- Disability Letter (VA)
- Other (1)
- Other (2)
- Resume
- Separation Notice (RIF)
- SF-15
- SF-50/ Notification of Personnel Action
- Transcript
If you are relying on your education to meet qualification requirements:
Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education.
Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.
This job is open to
- The public
U.S. Citizens, Nationals or those who owe allegiance to the U.S.
Job Summary
Full Time
$72k-88k (estimate)
08/13/2024
10/01/2024
The job skills required for Quality Assurance Specialist include Quality Assurance, Customer Service, Quality Control, Packaging, Product Quality, Process Improvement, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Assurance Specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Assurance Specialist. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Quality Assurance Specialist positions, which can be used as a reference in future career path planning. As a Quality Assurance Specialist, it can be promoted into senior positions as a Quality Assurance Specialist III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Assurance Specialist. You can explore the career advancement for a Quality Assurance Specialist below and select your interested title to get hiring information.
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