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Manager, quality management, corporate compliance entry level jobs - 14 jobs
Medical Device Regulatory Affairs Strategist
Oracle
Columbus, OH
**About the Role:** At a time when global technological developments and healthcare regulations are occurring and changing at an unprecedented rate, the success of large, complex global health companies requires regulatory leaders who are deeply steeped in the public and private levers that impact this industry. To remain competitive in this rapidly changing landscape, organizations require regulatory affairs professionals who can navigate complex and fast-changing laws, regulations, and public policies across the globe. In this context, we are looking for regulatory affairs experts in the med-tech space to play a key role in driving Oracle's success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work in collaboration with product engineering and development teams and subject matter experts on the total product lifecycle of AI-enabled, Cloud-native software applications used in clinical operation, clinical information systems, and clinical decision support (medical device and non-medical Device). You will help prepare the required documentation to register products in global markets where the products are sold. You will establish strong partnerships with the business to identify and ensure compliance with regulatory requirements throughout the product lifecycle from development to product launch to post-market activities of software products in scope. You will work on defining the regulatory strategies for products in development, premarket submissions, post-market reporting, responses to regulatory inquiries, and post-market compliance (e.g. advertising / promotion, etc.), as applicable. You will work primarily with the Oracle Health & Life Sciences business units but will also interact with all Oracle business units selling products to the health and life sciences industries. This role requires an individual who can keep up with the fast-paced environment of software development and an evolving regulatory landscape. For this role we are seeking a regulatory strategist who is collaborative, a creative problem solver, and dedicated to excellence in their work. **About the Business:** Oracle's Healthcare and Life Sciences business is a global leader in industry-specific software and solutions to healthcare providers, payers, pharmaceutical companies, medical device companies, and clinical research organizations. We offer a range of products and services, including AI/ML solutions, cloud-based healthcare platforms, data analytics, electronic health records (EHR), and patient engagement systems. The business aims to help organizations improve patient outcomes, lower costs, and accelerate innovation. By leveraging Oracle's technology and expertise, healthcare and life science organizations can streamline their operations, gain insights from data, and make more informed decisions. Oracle also enables secure and compliant handling of sensitive healthcare data, helping organizations meet regulatory requirements and protect patient privacy. With a focus on digital transformation, Oracle's Healthcare and Life Sciences business empowers the industry to embrace modern technologies and improve overall healthcare delivery. **What You'll Do:** + Work closely with Oracle's product engineering teams to assess product functionality and develop regulatory strategy. + Collaborate cross-functionally with other teams to create and manage pre-market submissions (including 510(k), CE Marking under EU MDR, Technical Files, applications to Health Canada, and other global submissions) across global market ensuring compliance with regulatory authorities. + Maintain documentation and post market surveillance report on an ongoing basis to maintain market authorization. + Support internal and external audits to identify, evaluate, disclose, and appropriately remedy risks and deficiencies. + Serve as a subject matter expert for internal clients with interpretation of applicable standards and regulations, and use of the quality management system. + Manage and compliance related projects for Health-related products. + Review and recommend changes to labeling, marketing communications, clinical protocols, design processes, and manufacturing procedures to maintain regulatory and quality compliance. + Maintain compliance with changing regulatory requirements across global markets that impact to our businesses, regulatory affairs function, and quality/compliance programs. **Responsibilities** **Preferred Qualifications:** + BA/BS or advanced degree preferred. + Experience with SaMD in areas such as Regulatory Affairs, Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring submissions (510k, EU Tech Files, etc.) required. Experience with sustaining and new product development is ideal. + Experience interacting with notified bodies and/or regulators preferred. + Ability to perform in a fast-paced and continually evolving business environment. + RAC, CQE, CPPS, CQA desired. + Experience in working within a quality management system, preferably with ISO 13485, ISO 14971, 60601, 21 CFR parts 1000/1001, or Quality System Regulations. + Understands continual improvement and risk management. Excellent written and verbal communication skills. + Ability to adjust and adapt to changing priorities in a dynamic environment. Disclaimer: Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates. Oracle uses Artificial Intelligence in our recruiting process. Read more about it in our Recruiting Privacy Policy (**************************************************************** . **Range and benefit information provided in this posting are specific to the stated locations only** CA: Hiring Range in CAD from: $78,500 to $128,500 per annum. US: Hiring Range in USD from: $87,000 to $178,100 per annum. May be eligible for bonus and equity. Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business. Candidates are typically placed into the range based on the preceding factors as well as internal peer equity. Oracle US offers a comprehensive benefits package which includes the following: 1. Medical, dental, and vision insurance, including expert medical opinion 2. Short term disability and long term disability 3. Life insurance and AD&D 4. Supplemental life insurance (Employee/Spouse/Child) 5. Health care and dependent care Flexible Spending Accounts 6. Pre-tax commuter and parking benefits 7. 401(k) Savings and Investment Plan with company match 8. Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation. 9. 11 paid holidays 10. Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours. 11. Paid parental leave 12. Adoption assistance 13. Employee Stock Purchase Plan 14. Financial planning and group legal 15. Voluntary benefits including auto, homeowner and pet insurance The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted. Career Level - IC4 Vacancy Type - New Position This role will be working on a regular basis with colleagues around the world. To support this collaboration, knowledge of English is required for this role. Proficiency in French is required for candidates residing in Quebec, otherwise it is considered an asset. **About Us** As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity. We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all. Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs. We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation-request_************* or by calling *************** in the United States. Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.$78.5k-128.5k yearly 60d+ agoQA Manager
Corporate & Technical Recruiters, Inc.
Columbus, OH
This position is responsible for the food safety, quality, and regulatory compliance of the production facility and for enabling the safety and quality assurance purpose and strategy through daily decision making and guidance. The manager will lead the plant FSQA team including hiring, onboarding, and team member development. Supervisory Responsibilities: • Ensure a fully staffed facility FSQA team with succession and development plans. • On-board, train, and retain new staff members. • Oversee the daily workflow of the department, and in alignment with other functions. • Partner with cross functional leaders to handle FSQA decision making. Duties/Responsibilities: Management • Serve as the authority for onsite food safety, quality, and regulatory compliance decisions. • Administer the site prerequisite programs and BRC program. Serve as BRC practitioner for the facility. • Understand, drive, and deliver FSQA related KPI results in areas such as environmental performance, sanitation effectiveness, and customer complaints. • Effectively empower a staff of food industry professionals to obtain company and facility objectives. • Ensure existing programs and procedures are verified and validated and represent optimal allocation of company resources. • Manage multiple complex projects simultaneously related to the needs of the business. • Serve, along with facility manager, as a primary representative to visitors, auditors, customers, and community. • Innovate and inspire a culture of creativity to continuously improve facility systems and programs. • Serve as liaison with local government agency representatives through the normal course of business and in the resolution of regulatory complaints. • Coordinate competing priorities and challenging deadlines; leverage cross-functional resources to achieve results. • Develop and maintain facility procedures critical to quality and food safety. • Champion the needs of the facility and the site FSQA organization by seeking mission-critical resources with data-based justifications. • Serve as on-call leader for areas of responsibility during off-hours. Customer Service • Maintain relationships with internal and external customers through compliance with contractual agreements, information exchange, and project collaboration. • Communicate directly with customers in written and oral capacities, serving as an instrument of an ongoing relationship management. • Facilitate third party and customer audits. • Handle complaints through root cause analysis, corrective actions, and preventive measures. Track, trend, and communicate to stakeholders. • Communicate effectively and frequently with leadership in other functional areas of the facility. Prioritize departmental functions to enable successful operations. • Support business projects by evaluating risks and serving as a subject matter resource. Team Building • Mentor and motivate team members. Build and execute development plans for team members at subordinate levels of the organization to prepare them for roles of increased responsibility. • Maintain an approved succession plan for yourself and your salaried reports. • Meet personnel objectives by planning, monitoring, appraising, and reviewing job contributions; providing awareness education, enforcing policies and procedures. • Use responsible delegation methods to balance workloads in the department and to ensure all team members are engaged according to their positions and talents. • Evolve the site quality organizational structure to suit the needs of the business. • Define job responsibilities within the department and institutionalize FSQA-related responsibilities outside the FSQA department through SOPs, standard work instructions, and by coordinating with other functional leaders. • Actively manage the acquisition and organization of talent in the FSQA department. • Facilitate a learning culture by training and mentoring staff from other functional areas in USDA, SQF, and HACCP programs and responsibilities. • Coordinate industry SQF and HACCP certifications for facility leadership. • Collaborate with Operations leaders and teams to implement initiatives to deliver all food safety and quality expectations. Continuous Improvement • Use tools and techniques of statistical process control to reduce defects. • Actively participate in cross-functional projects related to quality and compliance of new and existing products. • Assist in scoping plant projects. Understand the impact that proposed changes have on processes and inform stakeholders. • Work cross-functionally with Operations, Maintenance, Scheduling, and Logistics to ensure initiatives are supported by the equipment, materials and processes necessary to drive sustainable results. • Utilize Lean Manufacturing tools to map and improve processes. • Drive a positive food safety and quality culture by championing behavior, education, and training. Technical Expertise and Ideation • Maintain current technical expertise in Global Food Safety Initiatives and customer-driven compliance schemes. • Understand the product channels and markets relevant to the business. • Recommend and champion new technologies and best practices which will support key objectives. • Understand how regulated product characteristics interact with specifications, labels, and policies. Safeguard facility and product compliance. • Serve as an expert resource in focused-improvement projects. • Function as tactical and strategic technical advisor to facility manager. Department and Company Strategies, Objectives and Systems • Develop clear, measurable objectives to support company and plant goals and benchmark their attainment. • Set and communicate food safety and quality strategies at the facility and drive their continuous refinement and progression. • Ensure that company policies are fully implemented and supported by plant procedures. • Accept additional responsibilities as needed in the support of company goals. Required Knowledge/Skills/Abilities: • Technical knowledge and good reasoning abilities. • Demonstrated sound situational judgment and the ability to manage risk. • Mature, enthusiastic, leader with a history of successful team building. • Superlative written and oral communications skills. • Excellent computer skills - advanced user of databases, spreadsheets, and propriety suites. • Good organization skills with the ability to plan projects/activities with a high energy level. • Creative problem solving skills and an orientation towards innovation. • Ability to establish credibility with others, as well as be decisive. • Ability to recognize and support the organizations preferences and priorities. Education and Experience: • Bachelor's degree in a technical discipline required. Graduate degree preferred. • HACCP, SQF certifications required, auditing accreditation preferred. • USDA meat processing experience preferred. • Relevant continuous improvement certifications preferred. • Ten years of progressive leadership in food safety and food quality. • Equivalent combinations of experience and training that provide the required knowledge, skills, and abilities.$75k-111k yearly est. 60d+ agoRisk and Compliance Manager
Community Health Centers of Greater Dayton
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. Management Manage 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 agoQA Manager
Sss of Parma
Independence, OH
About Us Signature Sauces is a family-owned manufacturing facility that packages various types of sauces for surrounding restaurants and grocery stores. Our facility is ever growing and we need friendly and reliable people to join us on our journey. No experience is necessary as we are willing to train on any position. If you're still wondering why you should join our team, here's a quick list of reasons: On the job training - no manufacturing experience required. Access to our comprehensive benefits package on day 1. Our pay is competitive; overtime is paid at time and a half. Benefits: 401(k) matching Dental insurance Disability insurance Employee discount at our sister company Stancato's Italian Restaurant Health insurance Health Savings Account Company Paid Life Insurance 5 Days Paid Time Off 2 Paid Sick Days Paid Holidays Paid Down Maintenance Days Retirement plan Vision insurance Free Catered Lunch Every Shift Company Provided Lockers & Lock Free Laundered Uniforms Performs a variety of duties relating to Quality Assurance in a facility specializing in sauces, dressings, marinades, and other fluid goods that is not only 3rd party inspected but USDA compliant. DUTIES AND RESPONSIBILITIES include the following: Day to day supervision of QA team (4-5 direct reports) Knowledge of food ingredient functionality Ability to read and analyze formulas Ability to write product specs and procedures Ability to collect and analyze data Must be able to use lab analytically equipment Knowledge and understanding of GMP's, SSOP's, food safety rules and regulations Knowledge of USDA and FDA regulations Complies with all company policies and procedures Must have excellent communication skills Understand and adhere to government regulations and documentation requirements Taking retains; of finished and raw product Oversees production QA checks and audits all data of daily production Handling all USDA paperwork Assurance of safe and sanitary practices upheld throughout the plant according to company policies and product specific events/tasks. Responsible for managing the Document Management Program Product testing against spec sheets Microbiological testing Master Sanitation Schedule Ensures Allergen Management Program is being followed Understands and can learn to write HACCP plans Ensures company Quality Management system is in place and up to date EDUCATION and/or EXPERIENCE Two to four years related experience and/or training; or equivalent combination of education and experience. This position requires a well organized individual that is self motivated and takes charge, is dependable and responsible, enjoys new opportunities and challenges, enjoys working with and developing people, deals with criticism calmly and effectively, is careful about detail and is thorough in completing tasks as assigned and on time, is flexible and open to change LANGUAGE SKILLS Able to read, analyze, and interpret ingredient specifications and recipes, general business periodicals, and or governmental regulations. Able to write and develop specific, accurate, and scalable recipes and procedure manuals. Able to effectively present information and respond to questions from customers, staff and owners. MATHEMATICAL SKILLS Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of weights and measures. Ability to apply concepts such as ratios, and proportions for ingredient and nutritional information. PHYSICAL DEMANDS While performing the duties of this job, the employee is frequently required to reach with hands and arms; and talk or hear. The employee is required to regularly stand, stoop, kneel and walk. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus. WORK ENVIRONMENT The noise level in the office environment is usually quiet. Exposure to outdoor elements is possible on a daily basis. Must be responsible for dressing accordingly and being prepared for any type of weather.$66k-104k yearly est. Auto-Apply 2d agoRegulatory Affairs & Quality Manager at Eleeo Brands
North American Properties
Cincinnati, OH
North American Properties and its portfolio companies believe that it all comes down to connections-people to each other; cities to their souls; partners to opportunities; and individuals to experiences that move them. We believe that by fulfilling people's desire for connectedness, we're creating happier places and experiences that in turn become more successful environments, more vibrant communities and ultimately, a better world. Since 1954, we've balanced a well-capitalized approach and a keen focus on successful execution with a willingness to question conventional wisdom, reimagining and expanding the possibilities for more than $7 billion of assets across the US. Whether developing multifamily, mixed-use, office, student housing, hotel or retail environments, we're driven to deliver more valuable, meaningful real estate and ventures that transform, inspire, delight and succeed by connecting us all with what matters most. ӗleeo brands is a household of thoughtful, high-quality, family-focused health & wellness brands that ensure a healthier, happier life is always within reach. We are seeking a Quality & Regulatory Affairs Manager for our Operations Team. Job Description The Manager of Regulatory Affairs & Quality will work directly with internal and external teams to ensure that all products meet quality and varying retail standards, are safe to use by consumers and that any human-related safety or regulatory-related copy claims and endorsements are allowable, tested and substantiated. This position is also responsible for assuring all products comply with any applicable US and Canadian regulations and requirements. These include but are not limited to listing and maintaining products with the FDA (Cosmetic, Drug and Food and Supplement), EPA, FIFRA, CPSC, INDA and ongoing state-specific regulations and registrations. This Manager is not expected to be expert in all regulatory and safety areas affecting the company, but can leverage outside consultants to inform the company's regulatory and product safety needs and facilitate execution against these needs. This individual is expected to be a team player and flex as needed based on broader team needs. Responsibilities will include: Proactively and positively work with and serve as a resource to the operations, quality, product development and marketing teams. Onboard new and existing suppliers with Supplier Standards, maintain a repository of documents provided and ask suppliers for updated documents as needed. Work with internal and external stakeholders to track and approve finished good quality documentation and investigate and resolve product quality issues if they arise. Collaborate with suppliers and formulators to identify acceptable raw material alternatives and replacements in order to react to supply chain disruptions and/or identify cost saving Manage and develop regulatory & quality documentation across all products and raw materials (SDS, Formula Cards, Certificates of Analysis, Spec Sheets, Naturally Derived Statements, etc; with consultative or 3rd party support if needed). Assist in new product development, reviewing all potential raw materials and formulas, and labels against key internal and external policies, standards and regulations. Inform and provide guidance on all labeling and marketing copy and manage internal processes for tracking and substantiation: claims, cautionary statements, use directions, drug facts, supplement facts, DOT regulations, Ensure all products fully comply with related Federal and State regulations (FDA Cosmetics, FDA Drugs, FDA Food, EPA and Cleaning Product Regulations). Ensure all products and business practices fully comply with varying retailer requirements and coordinate related testing if needed. Ensure all data, product certifications, SDSs, and other key information are loaded into and reflected correctly on our website(s) and other online portals like WERCS, SmarterX and Label Insights. Relay, manage and coordinate any required product testing: claims, endorsements (i.e. Clean Label Project, USDA Organic, Non-GMO), performance, safety/toxicity, micro, human testing, retail compliance, etc. Manage regulatory related licenses and registration (i.e. Oregon Board of Pharmacy) Manage product formulation, regulatory and safety inquiries that come from retailers, consumers, suppliers or other external parties. Proactively track (with the help of outside consultants and via participation in trade associations) the key regulatory trends that could impact the business and summarize potential implications and recommendations regarding these trends. Qualifications/Requirements: Regulatory experience required, Quality and/or Operations experience preferred Project Management experience is not required but advantageous Strong working knowledge of Microsoft Office & Google for Businesses Solid organizational skills and attention to detail Excellent written and verbal communication skills Lead and direct the work of others and manage up if needed Bachelor's Degree in appropriate field of study or equivalent work experience Preferred Skills: Knowledgeable in Organic Product Certification and Labelling Standards under USDA and NSF/ANSI 305. Familiar with Product Labelling/Claims Regulations in the Food, Cosmetics and Cleaning Products areas (FDA, MoCRA, CPSC, Prop 65, CA SB258 among others). Experience with similar International Regulations is a +. Previous knowledge of FDA online reporting portals (FEI, NDC, MoCRA, SPL, COSM, 510k Device) is a +. Interested candidates should forward their resume and references to *********************** Regulatory Affairs & Quality Manager in the subject line. About North American Properties NAP upholds a professional and deadline‐oriented working environment in an office setting. At NAP, we live our values of Relationships, Ownership, Agility, Strength, and Stability, Courage and Creativity, Empowerment, and Integrity. North American Properties does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. We look forward to hearing from you!$97k-155k yearly est. Auto-Apply 31d agoQuality Compliance Manager
Grifols Sa
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+ agoQA MANAGER
Signaturesauces
Independence, OH
About Us Signature Sauces is a family-owned manufacturing facility that packages various types of sauces for surrounding restaurants and grocery stores. Our facility is ever growing and we need friendly and reliable people to join us on our journey. No experience is necessary as we are willing to train on any position. If you're still wondering why you should join our team, here's a quick list of reasons: On the job training - no manufacturing experience required. Access to our comprehensive benefits package on day 1. Our pay is competitive; overtime is paid at time and a half. Benefits: 401(k) matching Dental insurance Disability insurance Employee discount at our sister company Stancato's Italian Restaurant Health insurance Health Savings Account Company Paid Life Insurance 5 Days Paid Time Off 2 Paid Sick Days Paid Holidays Paid Down Maintenance Days Retirement plan Vision insurance Free Catered Lunch Every Shift Company Provided Lockers & Lock Free Laundered Uniforms Performs a variety of duties relating to Quality Assurance in a facility specializing in sauces, dressings, marinades, and other fluid goods that is not only 3rd party inspected but USDA compliant. DUTIES AND RESPONSIBILITIES include the following: Day to day supervision of QA team (4-5 direct reports) Knowledge of food ingredient functionality Ability to read and analyze formulas Ability to write product specs and procedures Ability to collect and analyze data Must be able to use lab analytically equipment Knowledge and understanding of GMP's, SSOP's, food safety rules and regulations Knowledge of USDA and FDA regulations Complies with all company policies and procedures Must have excellent communication skills Understand and adhere to government regulations and documentation requirements Taking retains; of finished and raw product Oversees production QA checks and audits all data of daily production Handling all USDA paperwork Assurance of safe and sanitary practices upheld throughout the plant according to company policies and product specific events/tasks. Responsible for managing the Document Management Program Product testing against spec sheets Microbiological testing Master Sanitation Schedule Ensures Allergen Management Program is being followed Understands and can learn to write HACCP plans Ensures company Quality Management system is in place and up to date EDUCATION and/or EXPERIENCE Two to four years related experience and/or training; or equivalent combination of education and experience. This position requires a well organized individual that is self motivated and takes charge, is dependable and responsible, enjoys new opportunities and challenges, enjoys working with and developing people, deals with criticism calmly and effectively, is careful about detail and is thorough in completing tasks as assigned and on time, is flexible and open to change LANGUAGE SKILLS Able to read, analyze, and interpret ingredient specifications and recipes, general business periodicals, and or governmental regulations. Able to write and develop specific, accurate, and scalable recipes and procedure manuals. Able to effectively present information and respond to questions from customers, staff and owners. MATHEMATICAL SKILLS Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of weights and measures. Ability to apply concepts such as ratios, and proportions for ingredient and nutritional information. PHYSICAL DEMANDS While performing the duties of this job, the employee is frequently required to reach with hands and arms; and talk or hear. The employee is required to regularly stand, stoop, kneel and walk. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus. WORK ENVIRONMENT The noise level in the office environment is usually quiet. Exposure to outdoor elements is possible on a daily basis. Must be responsible for dressing accordingly and being prepared for any type of weather.$76k-113k yearly est. Auto-Apply 10d agoQuality Compliance Manager
Biomat USA, Inc.
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$74k-107k yearly est. 60d+ agoQA MANAGER
Stancatos
Independence, OH
About Us Signature Sauces is a family-owned manufacturing facility that packages various types of sauces for surrounding restaurants and grocery stores. Our facility is ever growing and we need friendly and reliable people to join us on our journey. No experience is necessary as we are willing to train on any position. If you're still wondering why you should join our team, here's a quick list of reasons: On the job training - no manufacturing experience required. Access to our comprehensive benefits package on day 1. Our pay is competitive; overtime is paid at time and a half. Benefits: 401(k) matching Dental insurance Disability insurance Employee discount at our sister company Stancato's Italian Restaurant Health insurance Health Savings Account Company Paid Life Insurance 5 Days Paid Time Off 2 Paid Sick Days Paid Holidays Paid Down Maintenance Days Retirement plan Vision insurance Free Catered Lunch Every Shift Company Provided Lockers & Lock Free Laundered Uniforms Performs a variety of duties relating to Quality Assurance in a facility specializing in sauces, dressings, marinades, and other fluid goods that is not only 3rd party inspected but USDA compliant. DUTIES AND RESPONSIBILITIES include the following: Day to day supervision of QA team (4-5 direct reports) Knowledge of food ingredient functionality Ability to read and analyze formulas Ability to write product specs and procedures Ability to collect and analyze data Must be able to use lab analytically equipment Knowledge and understanding of GMP's, SSOP's, food safety rules and regulations Knowledge of USDA and FDA regulations Complies with all company policies and procedures Must have excellent communication skills Understand and adhere to government regulations and documentation requirements Taking retains; of finished and raw product Oversees production QA checks and audits all data of daily production Handling all USDA paperwork Assurance of safe and sanitary practices upheld throughout the plant according to company policies and product specific events/tasks. Responsible for managing the Document Management Program Product testing against spec sheets Microbiological testing Master Sanitation Schedule Ensures Allergen Management Program is being followed Understands and can learn to write HACCP plans Ensures company Quality Management system is in place and up to date EDUCATION and/or EXPERIENCE Two to four years related experience and/or training; or equivalent combination of education and experience. This position requires a well organized individual that is self motivated and takes charge, is dependable and responsible, enjoys new opportunities and challenges, enjoys working with and developing people, deals with criticism calmly and effectively, is careful about detail and is thorough in completing tasks as assigned and on time, is flexible and open to change LANGUAGE SKILLS Able to read, analyze, and interpret ingredient specifications and recipes, general business periodicals, and or governmental regulations. Able to write and develop specific, accurate, and scalable recipes and procedure manuals. Able to effectively present information and respond to questions from customers, staff and owners. MATHEMATICAL SKILLS Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of weights and measures. Ability to apply concepts such as ratios, and proportions for ingredient and nutritional information. PHYSICAL DEMANDS While performing the duties of this job, the employee is frequently required to reach with hands and arms; and talk or hear. The employee is required to regularly stand, stoop, kneel and walk. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus. WORK ENVIRONMENT The noise level in the office environment is usually quiet. Exposure to outdoor elements is possible on a daily basis. Must be responsible for dressing accordingly and being prepared for any type of weather.$76k-113k yearly est. Auto-Apply 10d agoHealthcare Regulatory Compliance
Edwards Health Care Services, Inc.
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 agoManager, Quality Assurance
Hikma Pharmaceuticals USA Inc.
Dayton, OH
Job Title: Manager, Quality Assurance Job Type: Full-Time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Quality Assurance Manager to join our team. In this role, you will be responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that products are manufactured in compliance with cGMP guidelines, USP and FDA, EU requirements. In addition, you will be responsible to direct batch record review, control and release, handle investigation process (CAPA) assuring that any discrepancies are investigated thoroughly and in a timely manner. Key Responsibilities: Regular and predictable onsite attendance and punctuality. Directs the batch record review process. Makes final accept/reject disposition on product lots. Assures batch is manufactured in compliance with NDA/ANDA/EU, cGMP and Validation parameters. Ensures that records are reviewed and released in a timely manner. Coordinates communication for status of lots and status of and resolves issues related to accept/reject disposition of batches. Places lots on HOLD if Quality issues are detected and notifies senior management. Coordinates destruction of rejected finished goods and assures destruction occurs in a timely manner. Expedites and prioritizes product releases by coordinating the Review, testing, and releases with site management to meet customer service requirements. Conducts routine investigation and departmental meetings to facilitate the performance of release function. Manages personnel for in-process filling and inspection/packaging monitoring Provide QA oversight of Operation for the entire Manufacturing process, supporting Clean room technicians and production technicians as needed to identify and address product quality compliance issues as they arise. Provide training and assistance to all Clean room and operation personnel for NCR, CAPA and Change Control. Provides QA review and approval of manufacturing investigations assuring timely review, follow-up, tracking and trending of MIRs. Perform Root Cause analysis and assure corrective action (CAPA) implementation associated with manufacturing investigations. Provide guidance to the investigation scientists on reporting and metrics required for different levels within organization. Performs QA review and approval of LIR's (Laboratory Investigation Reports). Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR's, Commissioning Documents, FAT's), engineering documents. Establish a qualification and Requalification program for Clean Room Certification and Recertification, for ISO 5 and 7 environments. Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff. Assists the QA management in developing on department budget. Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions. Manages attendance records for all direct reports. Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: Minimum: Bachelor's degree in Pharmacy, Biology, Chemistry or a related field Preferred are beneficial [List the required qualifications such as education, skills, and experience] Preferred Qualifications: Additional college courses in Microbiology, cGMPs, Statistics or Quality Management Skills: Must have history of strong documentation skills and attention to detail Familiarity with cGMPs and CFR for US and EU Excellent organizational skills and ability to multi-task and perform work in a timely manner Demonstrates ability to lead a department, projects and meetings effectively Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management General computer skills and ability to prepare presentations and address large groups Demonstrated attention to details and accuracy The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must Compensation: Base Salary: $92,850 to $158,450 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.$92.9k-158.5k yearly 54d agoRisk and Compliance Manager
Community Health Centers of Greater Dayton
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. Management Manage 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. 12d agoQuality Assurance Manager
Everstaff
Cleveland, OH
EverStaff, a specialized recruiting firm, is actively searching for a potential candidate for a Direct Hire position with one of our top clients. This position entail direct employment with the client that offers exceptional work culture, benefits, PTO, and growth potential. Title: Quality ManagerPay Rate: $70,000/yr. - $80,000/yr.Shift: 1st JOB SUMMARY Responsible for quality inspection procedures and testing for raw materials and finished products. Conduct daily monitoring and enforcing Good Manufacturing Practices in Production and Warehousing. Verify compliance of all applicable regulatory standards, including but not limited to FDA, ODA, HACCP and FSMA standards. PRIMARY RESPONSIBILITIES Design and implement quality inspection procedures for raw materials and finished products. Daily monitoring of all quality test results for raw materials and finished products. Establish corrective and preventive actions when needed. Supervise and guide the work of the laboratory technician Define and implement Good Manufacturing Practices in Production and Warehousing. Conduct daily monitoring and enforcing of GMPs. Review and validate certificate of analysis (COA) for all incoming materials and perform quality tests as needed. Verify compliance of all applicable regulatory standards, including but not limited to FDA, ODA, HACCP and FSMA standards. Perform and review all applicable environmental and sanitation testing Keep records of quality reports, statistical reviews, and relevant documentation KNOWLEDGE AND SKILL REQUIREMENTS FSQA Certification Thorough knowledge of methodologies of quality assurance and standards BSc/BA in relevant field Excellent numerical skills and understanding of data analysis/statistical methods Good knowledge of MS Office and databases Great attention to detail and a result driven approach Excellent organizational and leadership abilities KEY COMPETENCIES Critical thinking and problem-solving skills Excellent fault-finding skills Excellent planning, organizational and time management skills Willingly provides assistance/support to others If you feel you have the above qualifications, please apply for immediate consideration. All qualified applicants will receive consideration for employment without regard to race, color, religion, ethnicity, national origin, sex, gender identity, sexual orientation, disability status, protected veteran status or any other protected status under the law. EverStaff is an equal opportunity employer (M/F/D/V/SO/GI)$70k-80k yearly 60d+ agoQA MANAGER
Sss of Parma
Independence, OH
About Us Signature Sauces is a family-owned manufacturing facility that packages various types of sauces for surrounding restaurants and grocery stores. Our facility is ever growing and we need friendly and reliable people to join us on our journey. No experience is necessary as we are willing to train on any position. If you're still wondering why you should join our team, here's a quick list of reasons: On the job training - no manufacturing experience required. Access to our comprehensive benefits package on day 1. Our pay is competitive; overtime is paid at time and a half. Benefits: 401(k) matching Dental insurance Disability insurance Employee discount at our sister company Stancato's Italian Restaurant Health insurance Health Savings Account Company Paid Life Insurance 5 Days Paid Time Off 2 Paid Sick Days Paid Holidays Paid Down Maintenance Days Retirement plan Vision insurance Free Catered Lunch Every Shift Company Provided Lockers & Lock Free Laundered Uniforms Performs a variety of duties relating to Quality Assurance in a facility specializing in sauces, dressings, marinades, and other fluid goods that is not only 3rd party inspected but USDA compliant. DUTIES AND RESPONSIBILITIES include the following: Day to day supervision of QA team (4-5 direct reports) Knowledge of food ingredient functionality Ability to read and analyze formulas Ability to write product specs and procedures Ability to collect and analyze data Must be able to use lab analytically equipment Knowledge and understanding of GMP's, SSOP's, food safety rules and regulations Knowledge of USDA and FDA regulations Complies with all company policies and procedures Must have excellent communication skills Understand and adhere to government regulations and documentation requirements Taking retains; of finished and raw product Oversees production QA checks and audits all data of daily production Handling all USDA paperwork Assurance of safe and sanitary practices upheld throughout the plant according to company policies and product specific events/tasks. Responsible for managing the Document Management Program Product testing against spec sheets Microbiological testing Master Sanitation Schedule Ensures Allergen Management Program is being followed Understands and can learn to write HACCP plans Ensures company Quality Management system is in place and up to date EDUCATION and/or EXPERIENCE Two to four years related experience and/or training; or equivalent combination of education and experience. This position requires a well organized individual that is self motivated and takes charge, is dependable and responsible, enjoys new opportunities and challenges, enjoys working with and developing people, deals with criticism calmly and effectively, is careful about detail and is thorough in completing tasks as assigned and on time, is flexible and open to change LANGUAGE SKILLS Able to read, analyze, and interpret ingredient specifications and recipes, general business periodicals, and or governmental regulations. Able to write and develop specific, accurate, and scalable recipes and procedure manuals. Able to effectively present information and respond to questions from customers, staff and owners. MATHEMATICAL SKILLS Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of weights and measures. Ability to apply concepts such as ratios, and proportions for ingredient and nutritional information. PHYSICAL DEMANDS While performing the duties of this job, the employee is frequently required to reach with hands and arms; and talk or hear. The employee is required to regularly stand, stoop, kneel and walk. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus. WORK ENVIRONMENT The noise level in the office environment is usually quiet. Exposure to outdoor elements is possible on a daily basis. Must be responsible for dressing accordingly and being prepared for any type of weather.$66k-104k yearly est. Auto-Apply 2d ago
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