Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
**Quality Systems & Training Manager**
**Summary:**
Evaluates processes, develops action plans, and coordinates the strategic implementation of quality system processes and corrective actions at the plasma donor center. Include who they report to and what positions they have on the team.
**Education:**
Bachelor of Science degree or equivalent.
**Primary Responsibilities:**
● Maintains oversight of the center's quality management system and ensures continuous quality improvement, by addressing deficiencies in a timely manner and communicating concerns to the appropriate parties.
● Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations. Implements Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance.
● Maintains oversight of center training program by ensuring compliance to program requirements promoting staff competency in their assigned job duties. Maintains and audits training records and files.
● Collaborates with Center Manager to ensure the donor center operates in a manner which assures product quality, donor suitability and donor safety are maintained.
● Responsible for the personnel functions of the Quality Associate; including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of personnel records, work schedule and delegation/follow-up of tasks.
● Responsible for oversight of all aspects of internal and external audits including audit preparation, execution, response, implementation of corrective/preventative actions, assessment of corrective actions, and follow-up as required.
● Continuously assesses, promotes, and improves the effectiveness of quality and training systems in the donor center through recognition of trends, investigation of failures in the execution of procedures, and direct observations.
● Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product.
● Investigates identified trends and performs follow-up on corrective and preventative actions, system implementations, and process improvement plans to measure/determine effectiveness.
● Oversees product and biohazard waste shipments: Ensures shipments meet regulatory specifications and product release requirements; ensures accurate labeling and documentation; and, authorizes final shipment.
● Performs a review of the documentation of unsuitable test results and unit lookback information.
● Performs a review of donor adverse event reports and the applicable related documentation.
● Ensures that job and center annual training (i.e. Advanced cGMP, Blood Borne Pathogen, and others as required) is completed, documented, and on file.
● Performs employee training observations to ensure staff competency prior to releasing employees to work independently.
● Ensures that all supplies and materials ordered meet quality requirements prior to use and are always stored in appropriate temperature/facility conditions. Initiates appropriate investigations if these requirements are not met. Initiates rejection of supplies for non-conformance.
● Determines donor suitability activities and manages donor deferrals as appropriate. Reviews and approves of deferred donor reinstatement activities.
● Prepares quality analysis reports to track issues and set goals. Does in depth research and analysis to resolve systemic compliance issues
● Ensures that Clinical Laboratory Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training have been properly documented.
● Holds monthly Quality Meeting to communicate status updates and manage action outcomes.
\#BiomatUSA
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
**Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.**
**Location: NORTH AMERICA : USA : OH-Whitehall:USWHIPC - Whitehall OH-E Main St-BIO**
Learn more about Grifols (**************************************
**Req ID:** 536924
**Type:** Regular Full-Time
**Job Category:** GENERAL MANAGEMENT
$74k-106k yearly est. 2d ago
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Full time Compliance/Flex Officer
Edifice Protection Group Inc. 4.1
Cleveland, OH
Job Description
The ideal security officer schedule: 40 hours per week (fill in for officers on vacation, with time off, etc.)
Pay Rate $15/hour PLUS A Sign On Bonus within 90 days of hire
Shifts available: Full Time/Part-time weekends 12-hour shifts
Location 5th Street Arcades
Company Benefits
Dental Insurance
Vision insurance
Health insurance
Life insurance
Paid time off
Paid training
Uniforms provided
Are you looking to put your exceptional customer services skills to work while providing a sense of safety and security as a Compliance Officer? We would love to hear from you. Security Patrols are the basis of this position, including foot patrols, watching for any irregularities at the site, supervising scheduled officers, and calling local authorities to respond to emergency issues. Daily Activity Reports (DAR) must be completed documenting internal and external incidents related to the building. Be the eyes and ears of the client by reporting any safety or maintenance concerns.
About Us: Edifice Protection Group Inc. is a Nation-wide Private Security Company. We provide Security Solutions for our Customers and their facilities throughout the United States. Through continuous learning, industry knowledge, and innovative thinking our team is poised to bring the best possible solutions. Our clients, distinctive in stature and structure, benefit from our forward thinking ideals and expertise.
$15 hourly 8d ago
Healthcare Regulatory Compliance
Edwards Health Care Services, Inc. 4.3
Hudson, OH
GEMCORE's continued success has earned us national recognition with Inc. Magazine's list of
America's Fastest-Growing Companies
and with the Cleveland Plain Dealer as
Top Workplace 6 years running!
We are looking for qualified candidates who share our enthusiasm and drive for winning and want to be part of our caring culture!
Are you looking for a role that is part of a key initiative that is vital for the growth of the organization? All the while allowing for work/life balance?
Edwards Health Care Services, Inc., a division of GEMCORE
is a well-established and growing healthcare distribution company specializing in highly efficient distribution through its nationwide wholesale, retail, and pharmacy divisions. We are seeking a highly motivated Healthcare Regulatory Compliance person to join our high energy, friendly team. The Regulatory Compliance's main responsibility is to assist in the successful administration of the Corporate Compliance Program. This role is vital in working closely with our growing Pharmacy in ensuring compliance with outside accrediting organizations, as well as state/federal licensing organizations.
We offer growth opportunities with potential for advancement
This position is an in-office position located in Hudson, OH
Schedule is 8:15 am - 5:00 pm, Monday through Friday
Employer paid vacation
Benefits available included medical/dental/vision, life, short and long-term disability insurances, and 401K Retirement Savings Plan
Ongoing training and development
Key Responsibilities:
Research federal and state regulatory requirements for the distribution of medical devices.
Process state and federal license applications to ensure medical device license requirements compliance.
Assists in the implementation and monitoring of compliance controls, compliance procedures and operational processes.
Conducts timely filings of reporting and renewal activity with licensing and regulatory agencies for Wholesale Distributor, DME and Pharmacy.
Maintain database and create electronic records of company contracts, licenses and agreements.
Inquires and responds to designated regulatory and accreditation agencies.
Maintains working knowledge of basic healthcare compliance legal and regulatory requirements.
Research regulatory changes that impact standard operating procedures and standards.
Be knowledgeable of the agencies, such as the state Pharmacy Boards, Departments of Health, Secretary of State offices, Drug Enforcement Agency (DEA), Food and Drug Administration (FDA), and USPTO, that issue the licenses and credentials maintained by the company.
Key requirements:
High attention to detail and excellent organizational skills
Strong reading comprehension ability
Qualified candidates must have excellent written, and verbal communication skills.
Demonstrated strong computer skills.
Knowledge of Process Improvement concepts.
Minimum 0-2 years of related experience in a consumer service or healthcare environment.
Ability to multi-task with established time management skills.
Bachelors' degree or equivalent experience.
About GEMCORE
GEMCORE, a family of companies headquartered in Hudson, Ohio -
Edwards Health Care Services, GEMCO Medical, GemCare Wellness, and GEM Edwards Pharmacy
- offers a core set of healthcare solutions by partnering with manufacturers, providers, employer groups, insurance groups, and patients to deliver high quality healthcare products and innovative services to proactively better lives. For more information, visit **********************
To learn more about this position and to view other openings, visit our career site: **************************************
$28k-55k yearly est. 17d ago
Risk and Compliance Manager
Community Health Centers of Greater Dayton 3.5
Dayton, OH
This position is responsible for identifying, implementing, monitoring, and evaluating the overall risk management and corporate compliance plans at Community Health Centers of Greater Dayton (CHCGD). This position works collaboratively with all disciplines to establish a safety culture, emphasizing clinical risk, patient safety, visitor, third party, volunteer, and employee safety, as well as potential business, operational, and property risks. Manages and monitors the CHCGD s compliance and Risk Management effort, reporting identified issues directly to the Chief Executive Officer.
Risk Management
Create Risk Management training plan for staff based on quarterly safety checks, incident report trends, observations by management team, annual OSHA and Compliance requirements, and other identified needs.
Maintain and update the CHCGD Risk Management Plan and ensure alignment with strategic goals.
Oversee or conduct risk assessments, walk through inspections, adverse event reports, past accreditation or licensing surveys, medical records, risk analysis methods to identify, evaluate, prevent and control the risk of injury or loss.
Identify, assess and mitigate clinical, operational, financial and reputational risks across the organization.
Report on Risk Management activities to the Risk Management Committee.
Prepare the quarterly and annual QA/Risk Management reports for the Board.
Coordinate submission of annual FTCA malpractice application
Oversee incident reporting and patient complaints and participate in root-cause analysis of occurrences or possible occurrences.
Participate in HRSA reporting and site visits.
Coordinate Disaster Management and Preparedness activities
Oversee the Respiratory Protection Plan and implementation.
Compliance
Develop, implement and maintain a comprehensive compliance program in accordance with HRSA, OIG, OSHA, FTCA and other regulatory requirements.
Serve at CHCGD s designated compliance officer.
Assists Quality Coordination, Operations staff and the Executive Management Team in the review, revision and formulation of appropriate policies and procedures to guide issues of compliance.
Assures compliance of federal, state, and local laws, as well as the HRSA Compliance Program.
Conduct regular compliance risk assessments and audits: develop corrective action plans as needed.
Participate in HRSA reporting and site visits.
Ensure ongoing compliance with CHCGD s Corporate Compliance Plan
Monitor and interpret changes in healthcare laws, regulations, and guidelines and update policies and procedures accordingly.
ManagementManage the Clinical Training Program
Lead the implementation of the infection control plan as well as respond to implementation questions from managers.
Assist with and/or conduct EHR/PM system training for staff and providers.
Coordinate the Clinical and EHR Training of staff (Manages Staff Development Specialist activities)
Qualifications, Skills, and Abilities
Working knowledge of Risk Management and Compliance processes.
In-depth knowledge of HRSA, FTCA, HIPAA, CMS and other relevant regulations.
Demonstrate initiative, ability to work with others and good professional judgment.
Able to work independently and organize time effectively.
Excellent written and verbal communication skills.
Strong organizational skills and attention to detail.
Able to work with confidential information.
Proficiency in MS Office products, such as Word, Excel, Power Point and Outlook.
Working knowledge of EHR
Coaching, mentoring, and teaching skills.
Ability to relate well to people from diverse ethnic and cultural backgrounds.
Motivate and inspire others by setting a positive example, solicit and/or provide innovative ideas from staff, co-workers, and physicians.
Open to feedback for improvement, willingness to change, and be flexible.
Required Knowledge, Licensure/Registration
Graduate of LPN or Registered Nursing program with current licensure or related healthcare degree preferred; BSN preferred.
Current CPR certification is required.
Ambulatory, CHC or primary care experience preferred. Familiar with standard concepts, practices, and procedures within healthcare office setting.
Previous experience with risk management and compliance required.
$63k-91k yearly est. 41d ago
Quality Compliance Manager
Grifols Sa 4.2
Whitehall, OH
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
Quality Systems & Training Manager
Summary:
Evaluates processes, develops action plans, and coordinates the strategic implementation of quality system processes and corrective actions at the plasma donor center. Include who they report to and what positions they have on the team.
Education:
Bachelor of Science degree or equivalent.
Primary Responsibilities:
● Maintains oversight of the center's quality management system and ensures continuous quality improvement, by addressing deficiencies in a timely manner and communicating concerns to the appropriate parties.
● Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations. Implements Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance.
● Maintains oversight of center training program by ensuring compliance to program requirements promoting staff competency in their assigned job duties. Maintains and audits training records and files.
● Collaborates with Center Manager to ensure the donor center operates in a manner which assures product quality, donor suitability and donor safety are maintained.
● Responsible for the personnel functions of the Quality Associate; including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of personnel records, work schedule and delegation/follow-up of tasks.
● Responsible for oversight of all aspects of internal and external audits including audit preparation, execution, response, implementation of corrective/preventative actions, assessment of corrective actions, and follow-up as required.
● Continuously assesses, promotes, and improves the effectiveness of quality and training systems in the donor center through recognition of trends, investigation of failures in the execution of procedures, and direct observations.
● Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product.
● Investigates identified trends and performs follow-up on corrective and preventative actions, system implementations, and process improvement plans to measure/determine effectiveness.
● Oversees product and biohazard waste shipments: Ensures shipments meet regulatory specifications and product release requirements; ensures accurate labeling and documentation; and, authorizes final shipment.
● Performs a review of the documentation of unsuitable test results and unit lookback information.
● Performs a review of donor adverse event reports and the applicable related documentation.
● Ensures that job and center annual training (i.e. Advanced cGMP, Blood Borne Pathogen, and others as required) is completed, documented, and on file.
● Performs employee training observations to ensure staff competency prior to releasing employees to work independently.
● Ensures that all supplies and materials ordered meet quality requirements prior to use and are always stored in appropriate temperature/facility conditions. Initiates appropriate investigations if these requirements are not met. Initiates rejection of supplies for non-conformance.
● Determines donor suitability activities and manages donor deferrals as appropriate. Reviews and approves of deferred donor reinstatement activities.
● Prepares quality analysis reports to track issues and set goals. Does in depth research and analysis to resolve systemic compliance issues
● Ensures that Clinical Laboratory Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training have been properly documented.
● Holds monthly Quality Meeting to communicate status updates and manage action outcomes.
#BiomatUSA
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.
Location: NORTH AMERICA : USA : OH-Whitehall:USWHIPC - Whitehall OH-E Main St-BIO
$76k-112k yearly est. 60d+ ago
Risk and Compliance Manager
Community Health Centers of Greater Dayton 3.5
Dayton, OH
Job Description
This position is responsible for identifying, implementing, monitoring, and evaluating the overall risk management and corporate compliance plans at Community Health Centers of Greater Dayton (CHCGD). This position works collaboratively with all disciplines to establish a safety culture, emphasizing clinical risk, patient safety, visitor, third party, volunteer, and employee safety, as well as potential business, operational, and property risks. Manages and monitors the CHCGD's compliance and Risk Management effort, reporting identified issues directly to the Chief Executive Officer.
Risk Management
Create Risk Management training plan for staff based on quarterly safety checks, incident report trends, observations by management team, annual OSHA and Compliance requirements, and other identified needs.
Maintain and update the CHCGD Risk Management Plan and ensure alignment with strategic goals.
Oversee or conduct risk assessments, walk through inspections, adverse event reports, past accreditation or licensing surveys, medical records, risk analysis methods to identify, evaluate, prevent and control the risk of injury or loss.
Identify, assess and mitigate clinical, operational, financial and reputational risks across the organization.
Report on Risk Management activities to the Risk Management Committee.
Prepare the quarterly and annual QA/Risk Management reports for the Board.
Coordinate submission of annual FTCA malpractice application
Oversee incident reporting and patient complaints and participate in root-cause analysis of occurrences or possible occurrences.
Participate in HRSA reporting and site visits.
Coordinate Disaster Management and Preparedness activities
Oversee the Respiratory Protection Plan and implementation.
Compliance
Develop, implement and maintain a comprehensive compliance program in accordance with HRSA, OIG, OSHA, FTCA and other regulatory requirements.
Serve at CHCGD's designated compliance officer.
Assists Quality Coordination, Operations staff and the Executive Management Team in the review, revision and formulation of appropriate policies and procedures to guide issues of compliance.
Assures compliance of federal, state, and local laws, as well as the HRSA Compliance Program.
Conduct regular compliance risk assessments and audits: develop corrective action plans as needed.
Participate in HRSA reporting and site visits.
Ensure ongoing compliance with CHCGD's Corporate Compliance Plan
Monitor and interpret changes in healthcare laws, regulations, and guidelines and update policies and procedures accordingly.
ManagementManage the Clinical Training Program
Lead the implementation of the infection control plan as well as respond to implementation questions from managers.
Assist with and/or conduct EHR/PM system training for staff and providers.
Coordinate the Clinical and EHR Training of staff (Manages Staff Development Specialist activities)
Qualifications, Skills, and Abilities
Working knowledge of Risk Management and Compliance processes.
In-depth knowledge of HRSA, FTCA, HIPAA, CMS and other relevant regulations.
Demonstrate initiative, ability to work with others and good professional judgment.
Able to work independently and organize time effectively.
Excellent written and verbal communication skills.
Strong organizational skills and attention to detail.
Able to work with confidential information.
Proficiency in MS Office products, such as Word, Excel, Power Point and Outlook.
Working knowledge of EHR
Coaching, mentoring, and teaching skills.
Ability to relate well to people from diverse ethnic and cultural backgrounds.
Motivate and inspire others by setting a positive example, solicit and/or provide innovative ideas from staff, co-workers, and physicians.
Open to feedback for improvement, willingness to change, and be flexible.
Required Knowledge, Licensure/Registration
Graduate of LPN or Registered Nursing program with current licensure or related healthcare degree preferred; BSN preferred.
Current CPR certification is required.
Ambulatory, CHC or primary care experience preferred. Familiar with standard concepts, practices, and procedures within healthcare office setting.
Previous experience with risk management and compliance required.
$63k-91k yearly est. 11d ago
Quality Compliance Manager
Biomat USA, Inc. 4.2
Whitehall, OH
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
**Quality Systems & Training Manager**
**Summary:**
Evaluates processes, develops action plans, and coordinates the strategic implementation of quality system processes and corrective actions at the plasma donor center. Include who they report to and what positions they have on the team.
**Education:**
Bachelor of Science degree or equivalent.
**Primary Responsibilities:**
● Maintains oversight of the center's quality management system and ensures continuous quality improvement, by addressing deficiencies in a timely manner and communicating concerns to the appropriate parties.
● Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations. Implements Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance.
● Maintains oversight of center training program by ensuring compliance to program requirements promoting staff competency in their assigned job duties. Maintains and audits training records and files.
● Collaborates with Center Manager to ensure the donor center operates in a manner which assures product quality, donor suitability and donor safety are maintained.
● Responsible for the personnel functions of the Quality Associate; including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of personnel records, work schedule and delegation/follow-up of tasks.
● Responsible for oversight of all aspects of internal and external audits including audit preparation, execution, response, implementation of corrective/preventative actions, assessment of corrective actions, and follow-up as required.
● Continuously assesses, promotes, and improves the effectiveness of quality and training systems in the donor center through recognition of trends, investigation of failures in the execution of procedures, and direct observations.
● Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product.
● Investigates identified trends and performs follow-up on corrective and preventative actions, system implementations, and process improvement plans to measure/determine effectiveness.
● Oversees product and biohazard waste shipments: Ensures shipments meet regulatory specifications and product release requirements; ensures accurate labeling and documentation; and, authorizes final shipment.
● Performs a review of the documentation of unsuitable test results and unit lookback information.
● Performs a review of donor adverse event reports and the applicable related documentation.
● Ensures that job and center annual training (i.e. Advanced cGMP, Blood Borne Pathogen, and others as required) is completed, documented, and on file.
● Performs employee training observations to ensure staff competency prior to releasing employees to work independently.
● Ensures that all supplies and materials ordered meet quality requirements prior to use and are always stored in appropriate temperature/facility conditions. Initiates appropriate investigations if these requirements are not met. Initiates rejection of supplies for non-conformance.
● Determines donor suitability activities and manages donor deferrals as appropriate. Reviews and approves of deferred donor reinstatement activities.
● Prepares quality analysis reports to track issues and set goals. Does in depth research and analysis to resolve systemic compliance issues
● Ensures that Clinical Laboratory Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training have been properly documented.
● Holds monthly Quality Meeting to communicate status updates and manage action outcomes.
\#BiomatUSA
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
**Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.**
**Location: NORTH AMERICA : USA : OH-Whitehall:USWHIPC - Whitehall OH-E Main St-BIO**
Learn more about Grifols (**************************************
**Req ID:** 536924
**Type:** Regular Full-Time
**Job Category:** MANUFACTURING