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Job Summary
The Director, Quality Management provides strategic oversight, leadership and direction to the Quality function and will be accountable for the CHPS (Cardinal Health Packaging Solutions – repackaging & bulk up) business unit within the Cardinal Health Pharmaceutical Segment.
What Quality Management contributes to Cardinal Health
Quality Management is responsible for developing and implementing quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications to ensure that products and services are reliable, safe and effective.
Demonstrates knowledge of quality systems and approaches.
Demonstrates an understanding of the relevant regulations, standards and operating procedures.
Demonstrates ability to perform investigations / root cause analysis and develop corrective actions.
Demonstrates an understanding of the requirements and has the ability to perform gap assessments to those requirements.
Demonstrates an understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, CAPA and problem solving.
Works cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements.
Build and foster One Team Quality Culture.
Responsibilities
Responsible for the release of final product before distribution to the market, including submission (by ensuring preparation of the adequate documentation) of the product.
As the head of the Quality Team for CHPS, ensure release of the final product in compliance with Good Manufacturing Practices, with the marketing authorization and regulatory requirements.
Manages deviations related to final product packaging components and/or raw materials disposition (e.g. root cause analysis, CAPA plan identification and follow-up) in a timely manner.
Ensures CAPAs for which the team is responsible are followed and closed within defined timelines.
Must be able to approve emergency change controls but understanding the nature of the content including intermediate steps and make the link with the final product and any regulatory requirement.
Understands release product issue and evaluate their potential impact on product quality and compliance.
Escalates complex issues to leadership in a timely manner.
Manages professional employees, frontline supervisors and business support staff while maintaining strong relationships with customers.
Prioritizes and ensures work is delivered in an efficient way.
Provides daily problem solving.
Represents Quality in meetings related to his/her area of responsibility internally and externally.
Performs other duties as assigned.
Qualifications
Bachelors and Advanced degree in related field or equivalent work experience, preferred.
10+ years’ experience in Biopharma, Pharmaceutical or Medical Device regulated fields.
At least 7-10 years of relevant work experience with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device), ISO and/or DEA regulated environments.
Experience with equipment qualification, software validation, test method validation, and/or process validation.
Works well with others and understand how to be successful in a team environment, especially since customer facing.
Detail oriented, organized, able to multi-task, a self-starter and self-motivated.
Proficient in Microsoft Word and Microsoft Excel and possesses strong technical writing skills.
What is expected of you and others at this level
Provides leadership to managers, experienced quality professionals and manage front line supervisors
Manages an organizational budget
Develops and implements policies and procedures to achieve organizational goals
Assists in the development of functional strategy
Decisions have an extended impact on work processes, outcomes, and customers
Interacts with internal and/or external leaders, including senior management
Persuades others into agreement in sensitive situations while maintaining positive relationships
Anticipated salary range: $112,500 - $181,650
Bonus eligible: Yes
Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
Medical, dental and vision coverage
Paid time off plan
Health savings account (HSA)
401k savings plan
Access to wages before pay day with myFlexPay
Flexible spending accounts (FSAs)
Short- and long-term disability coverage
Work-Life resources
Paid parental leave
Healthy lifestyle programs
Application window anticipated to close: 6/8/2024 *if interested in opportunity, please submit application as soon as possible.
Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
To read and review this privacy notice click here
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About the Unit
This Department drives Quality, Safety, and Experience (QSE) initiatives for their local hospitals set forth by regional and systemwide QSE initiative and goals. This department works with Executive teams, clinical teams, Directors, Managers, and Medical staff to analyze data and outcomes in order to drive quality improvement work that is aligned with our QSE goals. The QSE department implements and operationalizes best practices and quality improvement methodology to achieve desired Quality and Safety Outcomes. Hybrid with 3 days/week on site minimum. Travel to facilities in Metro Detroit is REQUIRED.
About Royal Oak Hospital
Recognized by U.S. News & World Report as the #2 hospital in Michigan and one of the top hospitals in the country. It is a major academic and referral center with Level I adult and Level II pediatric trauma designations. The advanced capabilities and clinical expertise within this center have earned it Magnet designation four consecutive times and has the distinct honor of housing Michigan’s first Diagnostic Imaging Center of Excellence.
Scope of work
Drives the Quality, Safety, and Experience (QSE) program for their assigned hospital(s) and/or other service area(s). Working with key stakeholders such as the Executive Team, Directors, Medical Directors, and Medical Staff. This individual will understand Corewell Health system-level and local goals, and to co-develop the roadmap of work necessary to achieve them. Works with other QSE leadership to adhere to best practice in implementing and operationalizing evidence-based practice and improvement methodology that is in alignment with System QSE.
How we will care for you, while you care for our patients
Qualifications
Primary Location
SITE - Royal Oak Hospital - 3601 W 13 Mile Road - Royal OakDepartment Name
Quality Safety and Experience - CH EastEmployment Type
Full timeShift
Day (United States of America)Weekly Scheduled Hours
40Hours of Work
8:00 a.m. to 4:30 p.m.Days Worked
Monday to FridayWeekend Frequency
N/ACURRENT COREWELL HEALTH TEAM MEMBERS – Please apply through Find Jobs from your Workday team member account. This career site is for Non-Corewell Health team members only.
Corewell Health is committed to providing a safe environment for our team members, patients, visitors, and community. We require a drug-free workplace and require team members to comply with the MMR, Varicella, Tdap, and Influenza vaccine requirement if in an on-site or hybrid workplace category. We are committed to supporting prospective team members who require reasonable accommodations to participate in the job application process, to perform the essential functions of a job, or to enjoy equal benefits and privileges of employment due to a disability, pregnancy, or sincerely held religious belief.
Corewell Health grants equal employment opportunity to all qualified persons without regard to race, color, national origin, sex, disability, age, religion, genetic information, marital status, height, weight, gender, pregnancy, sexual orientation, gender identity or expression, veteran status, or any other legally protected category.
An interconnected, collaborative culture where all are encouraged to bring their whole selves to work, is vital to the health of our organization. As a health system, we advocate for equity as we care for our patients, our communities, and each other. From workshops that develop cultural intelligence, to our inclusion resource groups for people to find community and empowerment at work, we are dedicated to ongoing resources that advance our values of diversity, equity, and inclusion in all that we do. We invite those that share in our commitment to join our team.
You may request assistance in completing the application process by calling 616.486.7447.
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CLA is a top 10 national professional services firm where our purpose is to create opportunities every day, for our clients, our people, and our communities through industry-focused wealth advisory, digital, audit, tax, consulting, and outsourcing services. Even with more than 8,500 people, 130 U.S. locations, and a global reach, we promise to know you and help you.
CLA is dedicated to building a culture that invites different beliefs and perspectives to the table, so we can truly know and help our clients, communities, and each other.
Our Perks:
Flexible PTO (designed to offer flexible time away for you!)
Up to 12 weeks paid parental leave
Paid Volunteer Time Off
Mental health coverage
Quarterly Wellness stipend
Fertility benefits
Complete list of benefits here
CliftonLarsonAllen, LLP is hiring an Assurance Director or Manager to support our Nonprofit practice, in Massachusetts. Office locations include: Boston, Quincy, Lexington, Andover, and Worcester.
How you’ll create opportunities in this Assurance Manager or Director role:
Manage and develop relationships with great clients.
Assist clients in obtaining necessary funding to continue to positively impact their community.
Assist clients with meeting their audit and financial planning objectives by using a range of tools.
Be creative with staff development, mentoring, and overseeing client engagement teams.
Lead the engagement progress by monitoring time budgets and deadlines for adherence.
Communicate important developments to the engagement principal along with facts, conclusions, and recommendations.
What you will need:
You have a Bachelor's Degree in Accounting, Finance, or a related field.
You have a minimum of 6 years of public accounting experience with emphasis in financial statement preparation and audits.
CPA license certification is required.
You jump at the chance to help others and you’re ready to lead a team of high-performing people.
You have a knack for solving issues and can confidently bring solutions to the table.
You love to work with clients’ to help their businesses succeed strategically.
#LI-BV1
Equal Opportunity Employer /AA Employer/Minorities/Women/Protected Veterans/Individuals with Disabilities.
Click here to learn about your hiring rights.
Wellness at CLA
To support our CLA family members, we focus on their physical, financial, social, and emotional well-being and offer comprehensive benefit options that include health, dental, vision, 401k and much more.
To view a complete list of benefits click here.
Official account of Jobstore.
CLA is a top 10 national professional services firm where our purpose is to create opportunities every day, for our clients, our people, and our communities through industry-focused wealth advisory, digital, audit, tax, consulting, and outsourcing services. Even with more than 8,500 people, 130 U.S. locations, and a global reach, we promise to know you and help you.
CLA is dedicated to building a culture that invites different beliefs and perspectives to the table, so we can truly know and help our clients, communities, and each other.
About the role:
CLA is looking to hire an Assurance Manager or Director in our Minneapolis office.
As an Assurance Manager or Director you will:
Assume full responsibility for planning, supervising, and controlling all phases of the Firm’s regular services for those clients delegated by Principals.
Assume in-charge responsibility; plan the timing, staffing and execution of assurance engagements to promote the most efficient operation and deliver value to our clients.
Lead the decision-making process for assigned engagements/clients; keep the Engagement Principal fully informed of major decisions and the engagement progress.
Develop a responsible and trained team through assistance in recruiting, planning assignments, resolving problems, providing direct consultation to staff, evaluating staff performance, and acting as an instructor or discussion leader in professional development programs.
Supervise preparation of the engagement letter for approval by the Engagement Principal, discuss the nature and terms of the assignment with the client, estimate fees, and ensure client signs and returns the engagement letter prior to the start of the engagement.
Evaluate internal controls and audit programs prepared by staff, revise as necessary, and present to the Engagement Principal for approval.
Follow the engagement progress through monitoring time budgets and deadlines for adherence; communicate important developments to the Engagement Principal along with facts, conclusions, and recommendations; provide ongoing attention to
client management; and prepare final client meetings.
What you'll need:
Bachelor’s Degree in Accounting, Finance, or related field.
6+ years of public accounting experience with emphasis in financial statement preparation, audits, reviews, and compilations.
Current CPA license required.
Advanced technical knowledge of audit, accounting, and tax concepts.
Ability to travel to client sites that requires overnight travel.
Demonstrated ability to manage client relationships.
Strong communication and analytical skills.
Ability to show strong leadership and mentoring capabilities.
Dynamic interpersonal manner with capacity to develop and train staff.
Excellent client service orientation with an ability to expand services and develop new business.
Our Perks:
Flexible PTO (designed to offer flexible time away for you!)
Up to 12 weeks paid parental leave
Paid Volunteer Time Off
Mental health coverage
Quarterly Wellness stipend
Fertility benefits
Complete list of benefits here
#LI-MM1
Equal Opportunity Employer /AA Employer/Minorities/Women/Protected Veterans/Individuals with Disabilities.
Click here to learn about your hiring rights.
Wellness at CLA
To support our CLA family members, we focus on their physical, financial, social, and emotional well-being and offer comprehensive benefit options that include health, dental, vision, 401k and much more.
To view a complete list of benefits click here.
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At HCSC, we consider our employees the cornerstone of our business and the foundation to our success. We enable employees to craft their career with curated development plans that set their learning path to a rewarding and fulfilling career.
Come join us and be part of a purpose driven company who is invested in your future!
Job Responsibilities
• Provide planning, implementation and monitoring of activities associated with regulatory and contractual requirements for government programs. Develop process and procedure flows to ensure that reports, or specific obligations mandated from government agencies are implemented by the appropriate business areas. Coordinate the development of policies and procedures designed to maintain the accuracy and timeliness of completing contractual requirements. Ensure that the process of filing certification and attestations with the government is documented.
• Analyze and oversee supportive data to prevent regulatory sanctions, foster regulatory relationships and integrate operations with regulatory requirements. This includes coordination with internal departments, i.e. Internal Audit, Special Investigations Department, Legal, as well as subcontractors to align for appropriate information collection and reporting. Work closely with Internal Audit and other business areas for the resolution of audit findings or other issues raised by the Government regarding non-compliance.
• Review and interpret regulatory documentation for adherence to standard criteria. Develop programs to accommodate corporate goals. Review filings made to government agencies.
• Perform reviews of various aspects of government programs and conduct investigations where necessary including investigations of any subcontractor, first tier entities, downstream entities and/or related entities.
• Prepare reports based on the completion of compliance reviews and investigations related to government programs.
• Design, implement, and monitor program projects and initiatives in all aspects of Government Programs.
• Serve as a resource on problematic issues generated from changing laws, regulations and guidance to maintain consistent/accurate interpretations.
• Participate in enterprise-wide initiatives and task forces in order to provide advice and guidance on compliance with government programs requirements.
• Manage reporting system to ensure that all contacts regarding possible non-compliance or misconduct involving a government program are properly logged, investigated and resolved including making recommendations to the Compliance Officer regarding whether disclosure should be made to the government, corrective actions, and disciplinary actions. Maintain documentation for each report of potential fraud, waste and abuse received through any reporting method (i.e. hotline, mail, in-person, exit questionnaires) which describes the initial report of non-compliance, the investigation, the results of the investigation, and all corrective actions and/or disciplinary action(s) taken as a result of the investigation.
• Direct research on laws and regulations to support investigative reviews related to government programs.
• Direct applicable audit functions to support investigative reviews of any potential wrongdoing related to government programs.
• Develop Corrective Action Plans and make recommendations regarding new policies and procedures based on risk assessments, compliance reviews, investigations or weaknesses.
• Identify needs and opportunities for communication to management regarding compliance issues and policies.
• Identify areas for training and communication to employees directly or indirectly related to Government Programs regarding compliance.
• Monitor Fraud, Waste and Abuse program as required under CMS guidelines and Medicaid contract including coordination with Special Investigations Department and Internal Audit
• Provide briefings on government programs requirements to the Compliance Officer, to the Board and its Committees and Compliance committees.
• Communicate and interact effectively and professionally with co-workers, management, customers, etc.
• Comply with HIPAA, Diversity Principles, Corporate Integrity, Compliance Program policies and other applicable corporate and departmental policies.
• Maintain complete confidentiality of company related business.
• Maintain effective communication with management regarding development within areas of assigned responsibilities and perform special projects as required or requested.
Required Job Qualifications:
* Bachelor’s Degree
* 8 years of auditing or investigative experience with a focus in government or compliance reviews.
* 5 years of managerial experience.
* Management and negotiation skills.
* Effective verbal and written communication skills.
Preferred Job Qualifications:
* 3-5 years of experience in a government programs health plan
*This is a hybrid role based in Albuquerque, NM and will sit in this office 3 days/week*
#LI-Hybrid
INJLF
#LI-EL1
Are you being referred to one of our roles? If so, ask your connection at HCSC about our Employee Referral process!
HCSC is committed to diversity in the workplace and to providing equal opportunity and affirmative action to employees and applicants. We are an Equal Opportunity Employment / Affirmative Action employer dedicated to workforce diversity and a drug-free and smoke-free workplace. Drug screening and background investigation are required, as allowed by law. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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About the Unit
This Department drives Quality, Safety, and Experience (QSE) initiatives for their local hospitals set forth by regional and systemwide QSE initiative and goals. This department works with Executive teams, clinical teams, Directors, Managers, and Medical staff to analyze data and outcomes in order to drive quality improvement work that is aligned with our QSE goals. The QSE department implements and operationalizes best practices and quality improvement methodology to achieve desired Quality and Safety Outcomes. Hybrid with 3 days/week on site minimum. Travel to facilities in Metro Detroit is REQUIRED
About Grosse Pointe Hospital
Recognized by U.S. News & World Report as one of the best hospitals in the nation. It is a Magnet-designated facility that provides exceptional nursing and advanced care services for our patients. This facility is home to The James and Patricia Anderson Surgical Center, a leading-edge, hybrid surgical unit that offers advanced technologies to perform a wide variety of procedures. It is also home to the Cotton Family Birth Center which has received the Baby Friendly designation by Baby-Friendly USA.
Scope of work
Drives the Quality, Safety, and Experience (QSE) program for their assigned hospital(s) and/or other service area(s). Working with with key stakeholders such as the Executive Team, Directors, Medical Directors, and Medical Staff. This individual will understand Corewell Health system-level and local goals, and to co-develop the roadmap of work necessary to achieve them. Works with other QSE leadership to adhere to best practice in implementing and operationalizing evidence-based practice and improvement methodology that is in alignment with System QSE.
How we will care for you, while you care for our patients
Qualifications
#Nursingeast324
Primary Location
SITE - Grosse Pointe Hospital - 468 Cadieux - Grosse PointeDepartment Name
Quality Safety and Experience - CH EastEmployment Type
Full timeShift
Day (United States of America)Weekly Scheduled Hours
40Hours of Work
8:00 a.m. to 5:00 p.m.Days Worked
Monday to FridayWeekend Frequency
N/ACURRENT COREWELL HEALTH TEAM MEMBERS – Please apply through Find Jobs from your Workday team member account. This career site is for Non-Corewell Health team members only.
Corewell Health is committed to providing a safe environment for our team members, patients, visitors, and community. We require a drug-free workplace and require team members to comply with the MMR, Varicella, Tdap, and Influenza vaccine requirement if in an on-site or hybrid workplace category. We are committed to supporting prospective team members who require reasonable accommodations to participate in the job application process, to perform the essential functions of a job, or to enjoy equal benefits and privileges of employment due to a disability, pregnancy, or sincerely held religious belief.
Corewell Health grants equal employment opportunity to all qualified persons without regard to race, color, national origin, sex, disability, age, religion, genetic information, marital status, height, weight, gender, pregnancy, sexual orientation, gender identity or expression, veteran status, or any other legally protected category.
An interconnected, collaborative culture where all are encouraged to bring their whole selves to work, is vital to the health of our organization. As a health system, we advocate for equity as we care for our patients, our communities, and each other. From workshops that develop cultural intelligence, to our inclusion resource groups for people to find community and empowerment at work, we are dedicated to ongoing resources that advance our values of diversity, equity, and inclusion in all that we do. We invite those that share in our commitment to join our team.
You may request assistance in completing the application process by calling 616.486.7447.
Official account of Jobstore.
About the Unit
This Department drives Quality, Safety, and Experience (QSE) initiatives for their local hospitals set forth by regional and systemwide QSE initiative and goals. This department works with Executive teams, clinical teams, Directors, Managers, and Medical staff to analyze data and outcomes in order to drive quality improvement work that is aligned with our QSE goals. The QSE department implements and operationalizes best practices and quality improvement methodology to achieve desired Quality and Safety Outcomes. Hybrid with 3 days/week on site minimum. Travel to facilities in Metro Detroit is REQUIRED.
About Troy Hospital
Recognized by the US News & World Report as one of the best in the nation for orthopedics and urological services. It has also been ranked #3 on the World’s Best Hospitals list by Newsweek. This state-of-the-art center provides advanced specialty and routine care with an emphasis on patient satisfaction and a focus on medical advancement.
Scope of work
Drives the Quality, Safety, and Experience (QSE) program for their assigned hospital(s) and/or other service area(s). Working with key stakeholders such as the Executive Team, Directors, Medical Directors, and Medical Staff. This individual will understand Corewell Health system-level and local goals, and to co-develop the roadmap of work necessary to achieve them. Works with other QSE leadership to adhere to best practice in implementing and operationalizing evidence-based practice and improvement methodology that is in alignment with System QSE.
How we will care for you, while you care for our patients
Qualifications
Primary Location
SITE - Troy Hospital - 44201 Dequindre Road - TroyDepartment Name
Quality, Safety and Experience - CH EastEmployment Type
Full timeShift
Day (United States of America)Weekly Scheduled Hours
40Hours of Work
8:00 a.m. to 4:00 p.m.Days Worked
Monday to FridayWeekend Frequency
N/ACURRENT COREWELL HEALTH TEAM MEMBERS – Please apply through Find Jobs from your Workday team member account. This career site is for Non-Corewell Health team members only.
Corewell Health is committed to providing a safe environment for our team members, patients, visitors, and community. We require a drug-free workplace and require team members to comply with the MMR, Varicella, Tdap, and Influenza vaccine requirement if in an on-site or hybrid workplace category. We are committed to supporting prospective team members who require reasonable accommodations to participate in the job application process, to perform the essential functions of a job, or to enjoy equal benefits and privileges of employment due to a disability, pregnancy, or sincerely held religious belief.
Corewell Health grants equal employment opportunity to all qualified persons without regard to race, color, national origin, sex, disability, age, religion, genetic information, marital status, height, weight, gender, pregnancy, sexual orientation, gender identity or expression, veteran status, or any other legally protected category.
An interconnected, collaborative culture where all are encouraged to bring their whole selves to work, is vital to the health of our organization. As a health system, we advocate for equity as we care for our patients, our communities, and each other. From workshops that develop cultural intelligence, to our inclusion resource groups for people to find community and empowerment at work, we are dedicated to ongoing resources that advance our values of diversity, equity, and inclusion in all that we do. We invite those that share in our commitment to join our team.
You may request assistance in completing the application process by calling 616.486.7447.
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Responsibilities:
Qualifications and Experience:
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Responsibilities:
Qualifications and Experience:
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The Chief QSV/HR is recognized as the technical authority in the interpretation of existing policies and the development of guidance on program management, performance and improvement, risk management and evaluation. Serves as a principle advisor to executive colleagues in the development of a continuous readiness improvement program and provides periodic reports on the status of the facility performance. Works closely with the NFSGVHS Director, Chief of Staff, Associate Director Patient Care and Nursing Service, Deputy and Assistant Directors and other senior clinical and non-clinical executives as an advisor and coach in quality principles, employee involvement (engagement), quality tools, and performance improvement implementation. He/she is the direct representative of the NFSGVAHS Director in driving performance improvement. He/she participates in VISN/National level activities that guide/instruct other facilities in management practices using performance improvement tools
and methodologies.
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The Assistant Service Chief, Quality Management (QM) / Lead Coordinator reports directly to the Chief, QM. He/she is responsible for promoting and coordinating the quality management program by demonstrating leadership, experience, and creative approaches as it relates to meeting current accreditation standards, performance measures and performance improvement activities to ensure high quality patient care. He/she coordinates necessary activities with individuals/services to obtain the information necessary to prepare for accrediting bodies and review groups include but are not limited to The Joint Commission, Office of the Inspector General (OIG), Commission on Accreditation of Rehabilitation Facilities (CARF), and VISN 10 and VA Central Office/Program Office Inspection Teams. The RN performs duties directly with the Chief of QM contributing to the management of the facility health care delivery system and the QM service. This position requires the ability to communicate with a variety of audiences from frontline staff to Senior/VISN leaders as well as managing, directing, overseeing, and administering numerous complex technical and analytical functions related to Quality, Safety, Value, Systems Redesign and High Reliability Organizational Standards across the Veterans Health Administration.
VA offers a comprehensive total rewards package: VA Nurse Total Rewards
Pay: Competitive salary, regular salary increases, potential for performance awards
Paid Time Off: 50 days of paid time off per year (26 days of annual leave, 13 days of sick leave, 11 paid Federal holidays per year)
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)
Licensure: 1 full and unrestricted license from any US State or territory
Work Schedule: Monday-Friday 0730-1400
Compressed/Flexible: Not Available
Telework: Available
Virtual: This is not a virtual position.
Permanent Change of Station (PCS): Not Authorized
Financial Disclosure Report: Not required
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Responsibilities:
Qualifications and Experience:
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