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  • Quality Supervisor

    Omni One 4.5company rating

    Quality systems specialist job in Columbus, OH

    Quality Supervisor - Automotive Industry Columbus, OH $85,000 - $95,000 Bonus and excellent benefits Are you a visionary leader with a passion for driving excellence and innovation? We're on the lookout for a dynamic Quality Engineering Leader to lead and inspire a talented team within our esteemed automotive corporation. Join a company with a rich history of producing exceptional products and an unwavering commitment to continuous improvement. With a solid customer base and a forward-thinking culture, we're primed for long-term success. Enjoy an exciting career with outstanding benefits, job security, and the opportunity to make a lasting impact! Why You'll Love It Here:Comprehensive Benefits Package Job Stability: Join a company with a proven track record and a strong reputation Growth Potential: Lead, develop, and make strategic changes that will shape the future Key Responsibilities:Lead and Develop: Inspire and guide a talented quality team to reach new heights Manage: Supplier quality programs and processes for new model launch Enhance Quality Systems: Drive the implementation and continuous improvement of quality systems Improve Process Controls: Identify and optimize key processes to maintain top-tier standards Engage on the Shop Floor: Be hands-on in resolving quality issues and driving improvements Supervise Operations: Oversee staffing, training, and daily operations within the quality department Customer Collaboration: Work directly with customers to address issues and drive solutions Cross-Department Liaison: Collaborate with various plant departments to ensure seamless operations What We're Looking For:Proven leadership skills to inspire and drive teams to success Expertise in PPAP, APQP, FMEA, and root cause analysis Knowledge of IATF and TS16949 standards Bachelor's degree in a relevant field, automotive experience, and a strong, stable work history Previous experience in a quality engineering or supervisory role within an automotive manufacturing environment Excellent communication and organizational abilities Apply Today: Send your resume to ****************** or call us at ************. All inquiries are kept confidential. Omni One specializes in placing Engineers and Technical Professionals. Our services are employer-paid (at no cost to you).
    $85k-95k yearly 4d ago
  • Air Quality Engineer

    Trinity Consultants 4.5company rating

    Remote quality systems specialist job

    About Us Trinity's core values represent an assurance of quality, professionalism, and reliability. To us, they are the foundation of our company, the standards against which we constantly judge ourselves. We are focused on client satisfaction, employee growth, and quality assurance. Trinity Consultants is committed to achieving optimal performance with minimal adverse environmental and societal impacts. Trinity is committed to the health and safety of our employees and the protection of the environment. Effective Health, Safety, and Environmental (HSE) protection in our business is every employee's responsibility for every activity that is conducted in our workplace or while at client facilities. ESSENTIAL DUTIES AND RESPONSIBILITIES Prepare air permit applications, for client projects in accordance with applicable local, state, and/or federal agency air regulations or standards. Perform emission calculations. Review and evaluate state and federal regulation applicability. Prepare, review, and submit regulatory reports and routine compliance reports as required by permits and applicable regulations. Review and analyze results of emissions testing. Knowledge or experience with air dispersion modeling. Assist clients with permitting strategy and developing pathways to continuous compliance. Communicate with clients and regulators as appropriate. Support preparation of proposals. Qualifications: Bachelor's, Master's, or other advanced degree in Environmental/Chemical/Civil Engineering. Minimum 2 years of experience in environmental consulting, focused on air quality. Advanced working knowledge of Excel and an understanding of the Windows operating system and Microsoft Office 365. Demonstrated understanding of state and federal air quality regulations and specific knowledge of general air permitting process: NSR, Title V, PSD, NSPS, NESHAP, BACT, etc. Excellent written and verbal communication skills and ability to coordinate and work effectively in a team setting. Ability to work independently in a remote work situation when needed. Excellent attention to detail and completeness. Must be able to perform multiple tasks with firm deadlines, sometimes deadlines could be simultaneous. (The specific statements shown in each section of this description are not intended to be all-inclusive. They represent typical elements and criteria necessary to successfully perform the job.) SUPERVISORY RESPONSIBILITIES This job has no supervisory responsibilities.
    $61k-78k yearly est. 4d ago
  • CMC Quality Manager, Analytical

    Loyal 4.7company rating

    Remote quality systems specialist job

    Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. Our mission is to help dogs live longer, healthier lives. We've already achieved significant milestones on our path to earning FDA approval for the first lifespan extension drug for any species. We have three products in our pipeline and are on track for FDA conditional approval within the next year. Loyal is a well-funded startup in growth mode. Our team includes scientists, veterinarians, engineers, operators, and creatives. This role will play a key role in supporting our growth strategies. About the role The CMC Quality Manager, Analytical, provides quality oversight and technical leadership for analytical development and testing activities supporting veterinary pharmaceutical products under FDA Center for Veterinary Medicine (CVM) guidance. This role ensures that analytical methods, stability programs, and product testing are scientifically sound, validated, and compliant with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and applicable regulatory expectations. The ideal candidate combines deep analytical chemistry expertise with a strong understanding of veterinary drug development, CMC regulatory requirements, and data integrity principles. Your daily work will include Analytical Quality Oversight Provide quality oversight for analytical method development, qualification, validation, and transfer in support of veterinary drug substance and drug product programs. Review and approve analytical study protocols, validation reports, method transfer packages, and specifications. Ensure that analytical testing, release, and stability studies are executed under GMP/GLP conditions and in compliance with FDA and ICH/VICH guidelines. Partner with Analytical Development, QC, and Manufacturing to ensure accuracy, reliability, and consistency of analytical data. Support establishment of phase-appropriate specifications, stability-indicating methods, and control strategies aligned with regulatory expectations. Regulatory & Compliance Responsibilities Ensure analytical activities comply with FDA-CVM, ICH, and VICH quality and data integrity requirements. Provide quality input for analytical sections of CMC documentation (e.g., INAD, NADA, VMF, and stability summaries). Participate in the preparation and review of regulatory submissions and responses to health authority questions. Support internal and external audits of analytical laboratories, contract testing organizations (CTOs), and contract manufacturing organizations (CMOs). Lead or assist in investigations (e.g., OOS/OOT results, deviations), ensuring root cause analysis, CAPA development, and timely closure. Quality Systems & Documentation Author, review, and approve SOPs, technical documents, and quality records associated with analytical testing, method lifecycle, and data management. Maintain inspection readiness and ensure compliance of analytical documentation with company policies and regulatory standards. Support implementation and continuous improvement of the Quality Management System (QMS) related to CMC and analytical operations. Contribute to risk assessments for analytical methods, materials, and laboratory processes. About you Bachelor's degree in a scientific discipline (Pharmaceutical Sciences, Chemistry, Veterinary Science, or related field). Minimum 5-7 years of relevant pharmaceutical industry experience, with at least 6 years in GxP QA roles. Broad understanding of drug substance and drug product development and manufacturing, analytical methods and testing, and quality incident management. Experience with solid dosage forms and/or veterinary drug products preferred. Demonstrated success working with external manufacturing partners (CDMOs). Strong knowledge of FDA CVM regulations, cGMP, and VICH guidelines applicable to veterinary products. Exceptional written and verbal communication skills. Ability to manage multiple projects and priorities in a fast-paced, remote work environment. Detailed eye for logistics and problem solving. Willing to work and comfortable in a fast-paced startup environment with a dynamic team. Familiarity with Google Workspace applications (e.g., Sheets, Slides, etc.) and electronic Quality Management Systems. Experience with international regulatory environments (EU, Canada, etc.) a plus. Salary range: $110,000 - $160,000 Loyal benefits Full-coverage health insurance - medical, dental and vision - for you and your dependents $1,000 home office equipment stipend $1,200/year learning budget for books, courses, etc. $250/month wellness budget for gym, cleaners, spa, food, etc. All 3-day weekends are turned into 4-day weekends 🎉 Unlimited vacation and paid holidays Paw-ternity leave - adopt a dog and get a day off with your new family member 🐶 Competitive salary Company equity options grant for new hires Loyal is founded and led by a first-gen female CEO and is proud to be an equal opportunity employer. We do not discriminate against applicants based on gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law. Our values Lean into moonshots We don't settle for incremental change. We have the bravery to take risks and shoot for the impact we want to have. Opportunity is at the intersection We lean into combining disciplines, expertises, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos. Expertise without ego Titles do not determine who has a voice. We work on hard technical problems and have a ton of fun while at it. Learning by doing Our path is novel and many things we are doing have never been done before. We lean into MVPs and are open to unexpected outcomes. Lead with context We value leading with context. We equip people with the context and background necessary to make their own decisions and act in the best interest of Loyal. We empower teams to succeed. Empathy and respect for all life Our patients are not just numbers. Our work is intentional, thoughtful, and guided by respect for life. We take our responsibility to pets and pet parents seriously.
    $110k-160k yearly Auto-Apply 24d ago
  • Quality Manager

    Invisible Technologies 4.0company rating

    Remote quality systems specialist job

    About Invisible Invisible Technologies makes AI work. Our end-to-end AI platform structures messy data, automates digital workflows, deploys agentic solutions, measures outcomes, and integrates human expertise where it matters most. Our platform cleans, labels, and structures company data so it is ready for AI. It adapts models to each business and adds human expertise when needed, the same approach we have used to improve models for more than 80% of the world's top AI companies, including Microsoft, AWS, and Cohere. Our successes span industries, from supply chain automation for Swiss Gear to AI-enabled naval simulations with SAIC, and validating NBA draft picks for the Charlotte Hornets. Profitable for more than half a decade, Invisible reached $134M in revenue and ranked as the number two fastest growing AI company on the 2024 Inc. 5000. In September 2025, we raised $100M in growth capital to accelerate our mission of making AI actually work in the enterprise and to advance our platform technology. About The Role As a company redefining operations through AI innovation, our ability to deliver consistently high-quality outcomes is at the core of the value we provide to our clients. We are seeking a detail-oriented and impact-driven Delivery Quality Manager to ensure that our AI training and multilingual data operations maintain the highest standards of accuracy, consistency, cultural relevance, and linguistic excellence. In this role, you will work in close collaboration with some of the most influential organizations in generative AI and LLM development. You'll act as a quality guardian across our enterprise delivery programs-ensuring that our human-in-the-loop (HITL) workflows, advanced multilingual data generation processes, and high-touch client services operate at peak precision and reliability. You'll partner with Operations Managers, project leads, and client stakeholders to define and implement robust quality assurance protocols, drive performance improvements, and cultivate a culture of continuous enhancement across delivery teams. From proactive QA audits to root-cause analyses, you'll play a mission-critical role in maintaining the trust and satisfaction of some of the world's most forward-thinking AI labs and companies. This position requires an analytical mindset, a sharp eye for detail, and a passion for operational excellence. Success in this role means not only identifying problems-but creating scalable systems and frameworks to prevent them. You'll be on the front lines of building the standards that shape how human-generated data trains and improves the AI models of tomorrow. What You'll Do Cross-Functional Collaboration: Work closely with Delivery, Product, Engineering, and Customer Success teams to address quality concerns and build preventive measures. Process Optimization: Identify process inefficiencies or gaps in both AI data and multilingual pipelines, and work with relevant teams to streamline operations and improve delivery accuracy and speed. Reporting & Insights: Generate regular reports and insights on delivery performance trends, multilingual QA activities, and recommendations to leadership. Quality Assurance Strategy: Develop and implement comprehensive QA frameworks for large-scale AI data and multilingual delivery workflows, aligned with industry best practices and internal standards. Tooling & Automation: Evaluate and implement QA tools and automation frameworks to streamline quality checks and reduce manual errors across delivery pipelines. What We Need Bachelor's degree in Operations Management, Engineering, Computer Science, Linguistics, or related field. Proven expertise in language QA concepts and workflows, including linguistic quality assessment, cultural adaptation, and managing multilingual projects. 5+ years of experience in quality assurance, service delivery, or operations, preferably in a tech, localization or AI-focused environment. Deep understanding of delivery and multilingual lifecycles, QA methodologies, and performance metrics. Experience working in agile environments and using project management tools Strong analytical skills with experience in data-driven decision-making. Familiarity with AI/ML concepts and workflows is a strong plus. What's In It For You Invisible is committed to fair and competitive pay, ensuring that compensation reflects both market conditions and the value each team member brings. Our salary structure accounts for regional differences in cost of living while maintaining internal equity. For this position, the annual salary ranges by location are: Tier 1$132,000-$147,300 USDTier 2$120,000-$134,000 USDTier 3$108,000-$120,000 USD You can find more information about our geographic pay tiers here. During the interview process, your Invisible Talent Acquisition Partner will confirm which tier applies to your location. For candidates outside the U.S., compensation is adjusted to reflect local market conditions and cost of living. Bonuses and equity are included in offers above entry level. Final compensation is determined by a combination of factors, including location, job-related experience, skills, knowledge, internal pay equity, and overall market conditions. Because of this, every offer is unique. Additional details on total compensation and benefits will be discussed during the hiring process What It's Like to Work at Invisible: At Invisible, we're not just redefining work-we're reinventing it. We operate at the intersection of advanced AI and human ingenuity, pushing the boundaries of what's possible to unlock productivity and scale. Ownership is at the core of everything we do. Here, you won't just execute tasks-you'll build, innovate, and shape the future alongside world-class clients pushing the boundaries of AI. We expect bold ideas, relentless drive, and the ability to turn ambiguity into opportunity. The pace is fast, the challenges are big, and the growth is unmatched. We're not for everyone, and we're okay with that. If you're looking for predictable routines, this isn't the place for you. But if you're driven to create, thrive in dynamic environments, and want a front-row seat to the AI revolution, you'll fit right in. Country Hiring Guidelines: Invisible is a hybrid organization with offices and team members located around the world. While some roles may offer remote flexibility, most positions involve in-office collaboration and are tied to specific locations. Any location-based requirements or hybrid expectations will be communicated by our Talent Acquisition team during the recruiting process. AI Interviewing Guidelines: Our hiring team thoughtfully uses AI to support an efficient, engaging, and inclusive interview process. Since AI can also be a helpful tool for candidates, we've outlined expectations for using it ethically throughout your interview journey. Click here to learn more about how we use AI and our guidelines for candidates. Accessibility Statement: We're committed to providing reasonable accommodations for individuals with disabilities. If you need assistance or accommodation due to a disability, please contact our Talent Acquisition team during the recruitment process at accommodation@invisible.email . Equal Opportunity Statement: We're an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or veteran status, or any other basis protected by law. Due to a high volume of candidates, Invisible may use automated decision-maker technologies to filter candidates based on response to our application questions and other provided information. Our use of automated decision-making enables us to be efficient by providing a manageable list of possible candidates that meet our mandatory hiring criteria. If you object to our use of automated decision-making please contact us.
    $132k-147.3k yearly Auto-Apply 17d ago
  • Quality Assurance Specialist

    STAQ Pharma Inc. 3.7company rating

    Quality systems specialist job in Columbus, OH

    Job Description STAQ Pharma is currently hiring for a Quality Assurance Specialist to join our team here in Columbus Effectively encourage and motivate associates to be successful and remain focused on Quality, Transparency, Safety and Availability objectives compatible with the company's mission and vision. Responsible for providing oversight of the Quality System; including managing control of documents (SOPs, WI, Specifications, Batch Records, etc.) that impact the identity, strength, quality, and purity of finished product, and providing support on Quality management projects. Duties/Responsibilities: Lead the document control program to ensure procedures meet CGMP requirements Manage training documentation and track employee compliance with training plans Issue GMP documents including Master Batch Production Records, Room and Equipment Logs, Document Change Orders, etc. Support in-process and finished product lot acceptance sampling and inspection Participate in investigations and problem solving of raw material, in-process, and finished product non-conformances with production personnel and/or supplier Develop and implement corrective and preventive actions geared toward continuous process improvements Support the finished product label printing and issuance process Write and implement standard operating procedures to meet and maintain FDA cGMP, USP, and state licensure requirements Provide supplier related support to production and receiving inspection team Other duties and tasks, as assigned Required Skills/Abilities: Excellent independent judgement and interpersonal skills Excellent mathematical, written communication, and verbal communication skills Strong technical writing skills and attention to detail Knowledge of and proficiency in the use of basic statistics Familiarity with Good Manufacturing Practices and FDA Regulations Supplier Auditing experience Knowledge of ERP System Proficient in using Microsoft Word, Excel, PowerPoint, Outlook: experience with OneNote and Publisher a plus Education and Experience: 2-5 years of Quality Assurance experience Pharmaceutical, Medical Device, or biotechnology industry experience, preferably in support of manufacturing B.S. or B.A. on Sciences or a relevant field or equivalent experience Professional certification in Quality Engineering or Quality Auditing, preferred Physical Requirements: Prolonged periods of sitting at a desk and working on a computer. Must be able to lift up to 15 pounds at times.
    $53k-83k yearly est. 12d ago
  • Customer Quality Manager

    SMA America 4.9company rating

    Remote quality systems specialist job

    Why Work at SMA America At SMA America, we believe in Energy that Changes . Since 1981, we've been developing innovative solar technology that simplifies, secures, and enhances the performance of photovoltaic systems - all while pushing the boundaries of what's possible in clean energy. But we're not just transforming power - we're empowering people. We've built a culture where bold ideas are welcomed, collaboration is second nature, and your career growth truly matters. With our Rocklin, CA headquarters as the hub, we offer a hybrid work model, competitive benefits, and a team-driven environment where your impact is seen and felt. Whether you're a sales expert, service pro, or engineering innovator, if you're ready to join a purpose-driven team committed to shaping the future of energy - we'd love to meet you. PURPOSE OF POSITION The Customer Quality Manager is accountable for the substantial timely management, tracking and coordination of any customer related quality topics in the US. The position ensures alignment and close teamwork with the customer quality team at the headquarters, supporting fast communication, a unified direction and mindset. PRIMARY DUTIES / RESPONSIBILITIES Leads, drives and tracks quality activities by supporting complete problem resolution of product failures with customer impact. Supervises and manages special projects with customer quality impact as needed or required. Initiates and manages the verification process of product problems or failures in a global network. Drives and tracks corrective actions utilized in the defined 8D steps. Manages, coordinates and tracks remedial actions with Supplier Quality Managers, Engineering, Service personnel as required in resolving product quality issues. Tracks and follows up on quality-related actions with all involved functions (Sales, Service, Production, Development) and escalates if deadlines are missed or deliverables are not met. Interfaces with customers to drive continuous quality improvement and facilitates customer audits or assessments upon request. Participates in on-site evaluations of non-conforming products in the field. Prepares documentation for decision making process within the global Quality Circle process. Applies statistical methods to track, trend, and analyze quality data related to non-conforming products reported by customers. Interfaces with international colleagues in the continual improvement of product/system/solution quality. Other duties as may be assigned by supervisor or management. REQUIRED RELEVANT PROFESSIONAL EXPERIENCE Bachelor's degree in engineering or electrical engineering (Master's preferred) or related field, or similar education At least 10 years of experience in the customer quality management field in a manufacturing environment Expertise in 8D method for corrective action and the quality tools 5-Why, Ishikawa diagramming, and pareto analysis. Profound project management skills especially including action tracking and special project management. Excellent communication skills in negotiations with critical / opposing parties. Ability to present information to formal mid/high-level management boards on quality issues. Excellent communication, leadership, and cross-functional collaboration skills. Strong skills in office suite: Word, Excel, Project, PowerPoint, and statistical software packages. Ability to travel occasionally. Working knowledge in JIRA, Salesforce, SAP, and CRM is a plus. Acts with an entrepreneurial mindset Certification in quality management (e.g., CQE, CQA, Six Sigma). Experience in solar, automotive, aerospace, electronics, or similar regulated industries. WE OFFER The salary range for this position is $104,000-134,000 per year, dependent upon experience Comprehensive benefits including health, dental and vision coverage (including $0 premium options) Dedicated Hybrid Schedule: In-Office Tuesday and Thursdays; remote on Monday, Wednesday, and Fridays 401(k) plan with company match Opportunities for professional development and training Inclusive, collaborative, and innovative work environment Our EEO Policy We are an equal opportunity employer and we make our employment decisions on the basis of merit and without regard to one's race, color, creed, sex (includes gender, pregnancy, childbirth and related medical conditions), gender identity, religion, marital status, age (over 40), national origin or ancestry, physical or mental disability (includes HIV/Aids), medical condition (cancer, genetic characteristics), veteran's status, sexual orientation, or any other consideration made unlawful by law. In accordance with applicable law protecting qualified individuals with known disabilities, SMA will attempt to reasonably accommodate qualified applicants with known disabilities, unless doing so would create an undue hardship on SMA. Any qualified applicant with a disability who believes he or she requires an accommodation in order to perform the essential functions of the job for which he or she is applying should identify the accommodation(s) needed in the application. Our Privacy Policy During your job application or recruitment process with us: (a) SMA may collect your personal information directly from you, such as when you submit your application and resume on our online portal or when you have job interviews with us. We may also obtain your personal information from third parties, including but not limited to your former employers, background or employment check service providers or third-party recruiters; and, (b) SMA may use or process applicants' personal information for relevant purposes including but not limited to general communications with you, identity verification, background or employment checks, determination of eligibility, and making hiring decisions. For successful job applicants who become SMA's staff, we may retain and integrate your personal information collected during the recruitment process into your records at SMA. For unsuccessful job applicants, [SMA may retain your application for internal records or for future recruitment purposes]. If you are a California resident, you have specific rights regarding your personal information under the California Consumer Privacy Act of 2018, as amended including by the California Privacy Rights Act of 2020, and its implementing regulations (the “CCPA”). This Company Personnel and Covered Individuals Privacy Notice for California Residents issued by SMA is applicable to you and explains your CCPA rights and our collection, use or disclosure of your personal information. If you have any question regarding our privacy policy, please contact us at US_DataPrivacy@sma-america.com
    $104k-134k yearly Auto-Apply 30d ago
  • Quality Systems Lot Disposition Specialist

    Hims & Hers

    Quality systems specialist job in New Albany, OH

    Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we're making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit hims.com/about and hims.com/how-it-works . For information on the company's outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit *********************************** About the Role: We are seeking a Quality Systems Lot Disposition Specialist to join our Quality Unit in XeCare Pharmacy. This position plays a critical role in ensuring that all compounded products meet company and regulatory standards before release. The role has a heavy emphasis on documentation surrounding batch issuance, review, filing, and escalation of events, and will support the QS Manager in daily operations. The QS Lot Disposition Specialist is responsible for ensuring compliance with USP standards, cGMP requirements, and internal SOPs while safeguarding patient safety. You Will: Manage batch record issuance, review, and final disposition of compounded lots. Perform detailed review of executed batch records to ensure accuracy, completeness, and compliance with cGMP and internal procedures. This practice will also include the scanning, filing, and archiving of site documents in both digital and physical systems. Audit documentation for compliance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available) Support the design and enhancement of quality system tools and workflows, ensuring alignment with regulatory requirements and business needs. Ensure timely filing and archival of batch-related documentation to support audit readiness. Participate in the escalation, investigation, and closure of deviations, OOS (out-of-specification) results, and discrepancies, ensuring timely investigation and resolution. Collaborate with Production, Pharmacy, QC, and Inventory teams to ensure smooth lot disposition activities. Provide reports, trending data, and metrics to QS management to identify patterns and continuous improvement opportunities. Support internal and external audits by providing documentation and evidence related to lot disposition. Participate in drafting and revising SOPs, work instructions, and protocols relating to lot disposition. GDP Additions Label Issuance* You Have: Bachelor's degree preferred in a relevant discipline (science, quality, or engineering-related field) or equivalent combination of education and experience. 3+ years of related experience in quality, manufacturing, or a regulated industry may substitute for a degree. Strong understanding of USP , , standards, FDA 21 CFR Parts 210 & 211, and cGMP. GDP and GLP practices preferred. Excellent attention to detail, documentation practices, and organizational skills. Experience with investigations, deviation management, and escalation procedures. Proficiency in Google Workspace and familiarity with quality systems software. Strong interpersonal and communication skills (written and verbal). Pharmacy Technician or trainee license or willingness to acquire. Our Benefits (there are more but here are some highlights): Competitive salary & equity compensation for full-time roles Unlimited PTO, company holidays, and quarterly mental health days Comprehensive health benefits including medical, dental & vision, and parental leave Employee Stock Purchase Program (ESPP) 401k benefits with employer matching contribution Offsite team retreats We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply-even if you're not sure if your background or experience is a perfect match. Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, please contact us at accommodations@forhims.com and describe the needed accommodation. Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability. Please do not send resumes to this email address. To learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement.
    $55k-73k yearly est. Auto-Apply 60d+ ago
  • Quality Systems Specialist

    Hitachi Astemo Ohio Manufacturing

    Quality systems specialist job in Sunbury, OH

    Quality Senior Specialist - Auditing Reports To: Manager I - Quality Systems Job Tasks, Objectives, Prerequisites, Etc. Prerequisites Ability to facilitate groups in root cause problem solving Ability to maintain confidentiality of information Ability to multi-task and handle large volumes of work in a fast-paced environment Ability to travel, occasionally with little notice, and some international travel. Ability to work flexible hours in support of 3-shift operations and video conferences with HQ in Japan. ASQ certifications in Auditing preferred Excellent communication skills with the ability to clearly and directly communicate both written and verbally. Knowledge of AIAG Quality standards (i.e. DFMEA, PFMEA, PCP, PPAP etc.) Microsoft Office expertise in Excel, Word, PowerPoint and Project Root Cause Problem Solving and Corrective Action (8D, 5P, 5 Why) Strong analytical troubleshooting and decision-making Strong follow-up skills Responsibilities 5S 3T compliance Adhere to Safety Policy and practices. Assist Associates with MQ1 Items Assure Conformance to requirements for outside audits Compile and Update Open / Past Due Audit CPR/Issue Reports Conduct Audits as Schedules (Training, Process Assurance, Quality Systems) Conduct Special Audits as required Confirm Audit Countermeasures Confirm Audit Findings Confirm Audit Requirements Coordinate Audits as scheduled (Training, Process Assurance, Layered Process Audits, Quality Systems) Develop and Manage Audit Schedules (Training, Process Assurance, Layered Process Audits, Quality Systems) Develop Checklist (Training, Process Assurance, Layered Process Audits, Quality Systems) Evaluate countermeasures proposed to correct negative trends Follow all company policies and regulations per the associate handbook or other written standards that apply to his / her job assignment Follow up and Analyze Audits (Training, Process Assurance, Layered Process Audits, Quality Systems) Lead special projects and other duties as required. MQ1 Audit System Verification New Hire Orientation Participate in CM meeting for findings from Outside Audits Participate in Outside Audits Perform additional projects assigned by department head and support all shifts as required Perform Product/Process Audits to verify products are manufactured and inspected in accordance with standards. Post Open / Past Due Audit CPR/Issue Reports weekly Prepare Associates for Outside Audits Prepare documentation for Outside Audits Reporting of Open/Past due Audit CPR's / Issues (Training, Process Assurance, Layered Process Audits, Quality Systems) Review completed audits for accuracy Support departmental 6S activities Update and Manage Auditor Training (Training, Process Assurance, Layered Process Audits) Verify / Close Audit findings Verify and Close Audits (Training, Process Assurance, Layered Process Audits, Quality Systems) Work cross-functionally across Operations, R&D, support departments and Corporate Quality to meet internal and customer quality requirements. Enter Layered Process Assurance Audits Review and approve Quality Documentation (PQCT Table II, Manufacturing and Operator Checksheets) Equal Opportunity Employer (EOE) - Qualified applicants will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender, identity, disability, protected veteran status and national origin. At Astemo, we're challenging the status quo with the power of diversity, inclusion, and collaboration. Our goal is to build an inclusive work environment that celebrates the differences of our employees. We want to ensure that every employee feels valued, respected and empowered. We don't just accept difference-we celebrate it, we support it, and we thrive on it for the benefit of our employees, our products, and our community. Astemo is proud to be an equal opportunity employer. If you need a reasonable accommodation to apply for a job at Astemo, please send the nature of the request and contact information to ************************* when applying for the position.
    $55k-73k yearly est. Auto-Apply 26d ago
  • Quality Manager - US

    GVS Spa

    Remote quality systems specialist job

    Quality Manager Quality Manager REPORTS TO: General Manager This position will fill a key leadership role in building and directing all company regulatory and quality system activities as it moves forward to develop and market its products. Oversees Quality for two plant locations; Sanford, ME and Westborough, MA ESSENTIAL JOB FUNCTIONS-RESPONSIBILTY & AUTHORITY: 1. Develop, implement, and lead an effective, globally complaint quality system to direct the design, the production, and distribution of company products. Including the development and transfer of projects with OEM contractors. 2. Direct regulatory due diligence and routine audits of internal operations and global contract suppliers to assure required regulatory compliance. 3. Direct and lead the regulatory requirements training in a dynamic organizational environment. 4. Act as the key company contact when interfacing with regulatory authorities. 5. Daily analysis of the material to be released. 6. Daily responsibility in walking and auditing the floor. 7. Responsible to check daily and weekly the scrap status, managing a dedicated meeting. JOB REQUIREMENTS: 1. Ten years of management experience in a regulatory / quality systems leadership role with a product development focused company 2. Proven capability in leading the team 3. Excellent working knowledge of US and EU regulations for medical device products. 4. Direct experience in working with US and EU regulatory authorities for medical devices. 5. Demonstrated leadership and management skills to direct responsibilities in an organization with both internal and outsourced globally directed projects. 6. Demonstrated balance of strategic thinking and execution oriented skills. 7. Excellent written and verbal communications skills 8. Experience with multi-standard management systems, including ISO 13485:2015, ISO 9001:2015, FDA QSR 820.00, ISO 14001:2015. 9. Position may require handling, labeling, moving and monitoring Hazardous and Universal Waste and will require training applicable to waste handling responsibilities. 10. Preferred - B.S. degree in a biological or natural science (biology, microbiology, biochemistry, chemistry, etc.) PHYSICAL REQUIREMENTS: 1. Employee will be required to sit / stand for extended periods of time, operate a computer and keyboard. 2. Position will be exposed to office environment with occasional interaction in a production and / or laboratory environment. Job Type: Full-time Benefits: * 401(k) * 401(k) matching * Dental insurance * Employee assistance program * Health insurance * Health savings account * Life insurance * Paid time off * Retirement plan * Vision insurance Schedule: * 8 hour shift Work Location: In-office/non-remote position Loading... Apply now Fill in the form below and send your application.
    $76k-109k yearly est. 7d ago
  • Manager, Clinical Quality

    Telix Pharmaceuticals

    Remote quality systems specialist job

    Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases. See Yourself at Telix The Manager, Clinical Quality will be part of a Telix team responsible for establishing, implementing and maintaining appropriate quality assurance processes and documented procedures to ensure that clinical trials are conducted and data are generated, recorded and reported in compliance with the protocol, GCP and the applicable regulatory requirement(s). The Manager, Clinical Quality will be responsible for planning, conducting and reporting audits and assessments of Good Clinical Practices (GCPs) Good Pharmacovigilance Practices (GVP), and Good Clinical Laboratory Practices (GCLPs) vendors, clinical investigator sites, laboratories, databases, essential documents, systems, processes and procedures. This position will be dedicated to providing quality oversight and compliance support to Telix's early and late-stage assets. Key Accountabilities Plan, arrange, schedule and conduct audits and assessments to ensure compliance with Good Clinical Practices (GCPs) Good Pharmacovigilance Practices (GVP), and Good Clinical Laboratory Practices (GCLPs). Ensure accurate audit documentation from audits of Clinical Investigator Sites, CROs, supporting laboratories, monitoring organizations and other vendors by writing audit plans, audit agendas and audit reports as well as tracking audit responses and resulting CAPAs. Drive inspection preparation activities for regulatory authority GCP/GCLP/GVP inspections and guide coordination of inspection responses. Provide Quality oversight and compliance support for Telix study, program, development and matrix teams by attending meetings, representing Clinical Quality and reviewing essential documents. Ensure accurate and timely review, investigation and closure of temperature excursions, product complaints and clinical trial related investigations. Review critical processes and procedures to identify gaps in standards, procedures and technologies that are a risk toclinical trial quality. Participate in initiatives related to critical quality processes such as risk management, data management, trial management, and investigational product management. Collaborate with the Clinical Operations team to write, revise, and approve appropriate SOPs, Work Instructions and Forms. Education and Experience Bachelor's degree in Life Sciences or related discipline, or equivalent experience in lieu of degree; Master's degree preferred American Society for Quality (ASQ) Certification in Quality Auditing, Quality Management, Six Sigma Green Belt or Six Sigma Black Belt preferred 7+ years of experience in Clinical Quality for Manager level or 9+ years in Clinical Quality for Sr. Manager level leading teams in the biotech/pharmaceutical industry Experience with FDA, TGA, PMDA, ICH and EMEA guidelines and regulations Excellent time management skills and the ability to work with a sense of urgency Strong oral and written communication including the ability to present information clearly and logically Ability to prioritize and manage multiple projects to meet critical deadlines Strong attention to detail and problem-solving skills Works effectively in a team environment Travel: 10% - 20% a year Key Capabilities Ethical Behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders. Collaboration: Work effectively as a part of a team, actively sharing knowledge and expertise to achieve common goals Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language. At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development. Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics. VIEW OUR PRIVACY POLICY HERE
    $76k-109k yearly est. Auto-Apply 1d ago
  • Quality Manager

    Heart of Ohio Family Hea Lth Centers 3.0company rating

    Quality systems specialist job in Columbus, OH

    The primary function of the Quality Program Manager is responsible for providing day to day management of the quality improvement program. Responsible for coordinating activities of quality department staff, suggesting process changes, measuring data, and completing QA activities to achieve organization goals for quality measures for programs like UDS, Accountable Care/Clinically Integrated Networks, Ohio Medicaid CPC, CPC Kids, CMC, and individual insurance plan contracts. Reports to: Director of Quality and Clinical Systems Supervises: Yes Dress Requirement: Business Casual Work Schedule: Monday through Friday during standard business hours Times are subject to change due to business necessity Exempt Essential Job Duties and Responsibilities Work with supervisor and members of clinical leadership to develop, implement, monitor, and measure plans to improve processes and quality outcomes. Work with supervisor, clinical leadership, data analytics team, and external data vendor Unity PHM to analyze data, clean data, and perform quality assurance activities. In collaboration with supervisor, Chief Medical Officer, and others, the position is responsible for carrying out system-wide quality programs. Assists with developing, planning, and implementing policies and procedures. Works closely with supervisors, clinical teams, and non-clinical teams for quality improvement efforts. Assists with designing processes for quality improvement purposes. Plays a key role in maximizing revenue from value-based care, pay-for-performance, and risk adjustment contracts. Ensure compliances with program requirements. Examples include individual insurance plan contracts, Accountable Care/Clinically Integrated Networks, Ohio Medicaid CPC, CPC Kids, and CMC programs. Focuses on better healthcare value and quality, including the improvement of clinical outcomes, patient experience, patient safety, costs, revenue, productivity, efficiency, employee and physician satisfaction, and process reliability. Leads or participates in meetings related to quality improvement. Coordinate, manage and report UDS measures and other data related to clinical quality. Manages performance improvement projects to assure milestones and key performance indicators are met within defined parameters. Documents the results of projects, and submits other documentation as requested. Develop and motivate department staff. Interview, monitor time and attendance, and manage performance of subordinates. Report on clinical quality measures internally and externally. Provide updates to internal and external stakeholders on progress in quality initiatives. Support data collection and reporting related to grants. This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice. Qualifications Education: Bachelor's degree in a related field required. Examples include nursing, healthcare administration, public health, or similar. Certifications such as CPHQ and Lean Six Sigma are beneficial, but not required. Experience: At least four years of experience in the healthcare field, quality, data analytics, and/or management strongly preferred. Master's level education and appropriate background may substitute for some experience. Knowledge of clinical operations including the functions of the front and back-office utilization information systems is preferred. Previous experience working in an outpatient clinic is preferred. Knowledge/Abilities: Excellent communication skills, both written and verbal, are required. Strong organization and time management skills are required. Ability to work independently and demonstrate initiative is required. Proficiency with Microsoft Office is required. Displays cheerful demeanor and makes positive comments when on duty. Works cooperatively with other staff members. Displays sensitivity in a multi-cultural environment. General understanding of the medical billing process is preferred. Equipment Operated : Telephone Computer Printer Fax machine Copier Other office equipment as assigned Other office and medical equipment as assigned Facility Environment : Heart of Ohio Family Health operates in multiple locations, in Columbus, OH. All facilities have a medical office environment with front-desk reception area, separate patient examination rooms, nursing stations, pharmacy stock room, business offices, hallways and private toilet facilities. All facilities are ADA compliant. The patient examination rooms and office area is: kept at a normal working temperature sanitized daily maintains standard office environment furniture with adjustable chairs maintains standard office equipment; i.e., computer, copier, fax machine, etc. at a normal working height Physical Demands and Requirements : these may be modified to accurately perform the essential functions of the position: Mobility = ability to easily move without assistance Bending = occasional bending from the waist and knees Reaching = occasional reaching no higher than normal arm stretch Lifting/Carry = ability to lift and carry a normal stack of documents and/or files Pushing/Pulling = ability to push or pull a normal office environment Dexterity = ability to handle and/or grasp, use a keyboard, calculator, and other office equipment accurately and quickly Hearing = ability to accurately hear and react to the normal tone of a person's voice Visual = ability to safely and accurately see and react to factors and objects in a normal setting Speaking = ability to pronounce words clearly to be understood by another individual
    $69k-90k yearly est. Auto-Apply 60d+ ago
  • Regulatory and Quality Assurance Specialist II (Remote)

    Us Fertility, LLC

    Remote quality systems specialist job

    Job Description US Fertility, the nation's largest partnership of physician-owned and physician-led top-tier fertility practices, a national network of premier IVF laboratories, are united under a shared mission to deliver the joy of parenthood through advanced reproductive medicine and innovative science. The Regulatory and Quality Assurance Special II is responsible for reviewing and implementing the applicable regulatory aspects and quality systems of the company while maintaining compliance with all regulatory agencies (FDA, State, Local and AABB). We have an immediate opening for a full-time Regulatory and Quality Assurance Special II to join our team. The schedule for this position is Monday-Friday 9am-5pm, and requires travel to Marlborough, MA once per month or as needed. How You'll Contribute: Implement, monitor, maintain, and improve the company's Quality System Implement, monitor, and maintain a document control system Interpret and assure conformance to federal and state regulations that are applicable to the products produced/processed Assure appropriate licensure is held and maintained by the company Facilitate quarterly meetings with medical directors to provide regulatory and quality updates Ensure medical directors complete all signoffs as required Assure compliance to international regulatory agencies Tracking and trending of laboratory, cryogenic, andrology, and deviation systems Maintain and improve deviation/non-conformance system Report events to regulatory bodies as applicable Assure training and competency of all staff Assist in preparation of regulatory strategies for changes to existing systems Participate in Continuing Education programs in related field Participate in planning and implementation of regulatory systems, document/change control and validation activities Establish and maintain good working relationships with department heads, regulatory authorities, and government agencies Implement and oversee audits for departments and systems to assure compliance to regulations and standards Track and ensure any identified deficiencies are rectified post an inspection/audit event Monthly and quarterly in person audits of quality and regulatory manuals and records Monthly and quarterly reports to leadership on Quality and Regulatory activities Perform other related duties as assigned by management What You'll Bring: Bachelor's degree or equivalent combination of training and experience Must have a high level of interpersonal skills to handle sensitive and confidential situations. Position continually requires demonstrated poise, tact, and diplomacy Must be able to interact and communicate professionally with individuals at all levels of the organization Clear and effective communication skills Proficiency in a variety of computer software applications in word processing, spreadsheets, database, and presentation software (MSWord, Excel, PowerPoint) Self-starter that adapts well to change in a fast-paced, dynamic environment Prior laboratory experience preferred Knowledge of industry, Federal and State regulations, licensing processes Strong aptitude for analyzing data, audit processes and reconciling records Demonstrated organizational skills and the ability to prioritize and coordinate multiple processes Excellent interpersonal skills and ability to work as part of a multi-disciplinary team and build and maintain effective working relationships. Excellent verbal & written communication skills Ability to work as part of a multi-disciplinary team Ability to organize and lead collaborative teams to facilitate quality projects (validations, corrective action plans, etc.) Occasional travel required (up to 25%) Able to adapt and thrive in the fast-paced, rapidly changing environment The successful candidate will have the ability to work well independently, as well as part of a team Excellent multi-tasking abilities More important than the best skills, however, is the right person. Employees who embrace our mission, vision, and core values are highly successful. What We Offer: Competitive pay + bonus Comprehensive training Medical, dental, vision, and 401(k) matching Generous paid time off and holidays Retirement plan Tuition assistance Ability to make an impact in the communities we serve At US Fertility, we promote and develop individual strengths in order to help staff grow personally and professionally. This is an ideal time to join our team! To learn more about our company and culture, visit here.
    $63k-94k yearly est. 8d ago
  • Quality Assurance Specialist

    MiCo2 Group

    Remote quality systems specialist job

    MiCo2 Group, LLC is currently seeking agents for Quality Assurance Specialists. Provide feedback on the level of customer service and processes for various companies! We are recruiting exceptional independent contractors to provide their insight while working from home. This is a part-time opportunity! You will be contacting companies based on general assignments. You WILL NOT be required to make any purchases, commitments or provide personal information. You will set your own schedule, so you can work anytime that fits YOUR schedule to meet the deadline. RequirementsResponsibilities: * Complete a test call successfully * Call all companies provided via assigned lists * Evaluate the level of customer service provided by answering representative * Document detailed information of overall experience * Complete review submission form before the required deadline * Ensure that form is free of errors and misinformation Requirements: * Must have valid United States Identification * Minimum 6 months customer service experience, preferably call center related * Moderate level of computer knowledge * Ability to work with minimal supervision * Must be self-directed and self-motivated * Strong listening skills * Accuracy * Efficiency * Excellent written and verbal communication skills Technical Requirements • Active Phone line (mobile or landline) • Mobile Device capable of downloading applications • CPU (Intel or AMD) 2GHz processor (or equivalent) • Resolution of 1,280 x 720 (720p) or greater • Internet Explorer 9.0 or higher BenefitsSave on gas Save on time
    $58k-90k yearly est. 60d+ ago
  • Beneficiary QA & Training Specialist

    Cybermedia Technologies

    Remote quality systems specialist job

    CTEC is a leading technology firm that provides modernization, digital transformation, and application development services to the U.S. Federal Government. Headquartered in McLean, VA, CTEC has over 300 team members working on mission-critical systems and projects for agencies such as the Department of Homeland Security, Internal Revenue Service, and the Office of Personnel Management. The work we do effects millions of U.S. citizens daily as they interact with the systems we build. Our best-in-class commercial solutions, modified for our customers' bespoke mission requirements, are enabling this future every day. The Company has experienced rapid growth over the past 3 years and recently received a strategic investment from Main Street Capital Corporation (NYSE: MAIN). In addition to our recent growth in Federal Civilian agencies, we are seeking to expand our capabilities in cloud development and footprint in national-security focused agencies within the Department of Defense and U.S. Intelligence Community. We are seeking to hire a Beneficiary QA & Training Specialist to our team! Join Us in Empowering Lives Through SSA's Employment Support Initiatives Are you passionate about making a meaningful difference in people's lives? The Social Security Administration (SSA) is committed to helping individuals with disabilities achieve greater independence through employment. By joining our team, you'll play a vital role in supporting this impactful mission-helping people unlock their potential, build confidence, and create brighter futures. If you're driven by purpose and inspired by the chance to make a lasting impact, we invite you to be part of a program that changes lives every day. The Beneficiary QA & Training Specialist is responsible for planning and conducting training for staff and Employment Network (EN) personnel, supporting the onboarding of new team members, and monitoring call and operational quality assurance within the program. This role develops and delivers training sessions, materials, and job aids to ensure staff and EN participants are knowledgeable about program processes, procedures, and standards. The Specialist also assists with new hire orientation and onboarding activities, supporting seamless integration into the team. In addition, the position monitors calls and operational activities, conducts quality assurance reviews, and provides feedback or recommendations to enhance service quality and compliance. Duties and Responsibilities: • Conduct training sessions for staff and EN personnel on program policies, procedures, and systems. • Develop and update training materials, guides, and job aids as needed. • Support onboarding and orientation activities for new hires, ensuring smooth integration. • Monitor inbound and outbound calls and review operations for quality assurance. • Perform call monitoring and operational quality reviews, documenting findings and providing recommendations for improvement. • Provide feedback and coaching to staff to support ongoing development and quality improvement. • Ensure all training and quality processes comply with program guidelines and standards. Requirements: • Bachelor's degree with 0-2 years of relevant experience, or High School diploma/GED with 6-8 years related experience. • Experience in delivering training and supporting onboarding in a professional setting. • Skilled in monitoring and evaluating customer service or operational activities for quality assurance. • Strong verbal and written communication abilities. • Attention to detail and strong organizational skills. • Ability to develop, revise, and present training and guidance materials. • Proficient with common office technology and communication tools. • Experience in a government or customer service environment preferred. Must be able to obtain and maintain a SSA Public Trust Clearance If you are looking for a fun and challenging environment with talented, motivated people to work with, CTEC is the right place for you. In addition to employee salary, we offer an array of employee benefits including: Paid vacation & Sick leave Health insurance coverage Career training Performance bonus programs 401K contribution & Employer Match 11 Federal Holidays
    $50k-79k yearly est. Auto-Apply 60d+ ago
  • Quality Assurance Specialist II, CMO

    Harrow, Inc.

    Remote quality systems specialist job

    Before reading the job post, we encourage you to watch this video about our company. It gives you an inside look at how we started, the team and culture that made us successful, and where we're going. It's easy to read a job post and apply, but people often wonder about the culture and whether they would fit in. If you want to call Harrow your home and genuinely want to be part of a family and something big, then we encourage you to click this link and get to know us. Who is Harrow? Harrow (Nasdaq: HROW) is a leading North American ophthalmic-focused pharmaceutical company. Harrow is an incredible entrepreneurial company - where we celebrate the ability of every member of the Harrow Family to be the CEO of their job. Harrow's values have driven interest over the past decade in attracting high-performing professionals in a variety of disciplines. Members of our Harrow Family often express their pride in being a part of our commitment to (1) innovation, (2) patient access to affordable medicines, and (3) our track record of having never turned down an ophthalmologist doing mission work around the world - providing free medicines in support of mission work aimed at giving or maintaining the gift of sight to those most in need . We encourage you to learn more about Harrow and its unique culture to see if you're the right person to help contribute as we build a truly exceptional company, one we are all so proud of! Harrow's ophthalmic pharmaceutical portfolio is one of the most comprehensive in the industry, including: An expanding Posterior Portfolio including IHEEZO and TRIESENCE A broad Dry Eye Disease product line, led by VEVYE and bolstered by well-known adjacent ocular surface disease products such as FLAREX and TOBRADEX ST A Specialty Anterior Segment product line, which includes various high-need and utility products such as ILEVRO , NEVANAC , and VERKAZIA Job Summary The QA Specialist II is responsible for overseeing and supporting external manufacturing operations of our global CMO Partners. The QA Specialist II position is an individual contributor role responsible for providing mid-level QA oversight of CMO operations in accordance with business agreements and international regulatory and industry standards. Secondarily, this role provides mid-level administrative support and basic general peer-to-peer guidance to junior team members to the internal quality department. Duties also include administrative tasks and projects for both the management and for members of the quality department. Core Responsibilities Partner closely with Harrow Eye's External Manufacturing, Supply Chain and Regulatory Affairs team to ensure consistent and collaborative communication to external manufacturing partners Work cross functionally to provide a single point of contact for QA technical support to internal team and external manufacturing partners Effectively communicate issues, risks, and proposed solutions within the organization Assist with, conduct and provide QA approval of investigations, CAPAs, changes, validation documentation, and other related GMP documentation. Provide communication, support, and guidance to manufacturing partners and within the QA CMO team Facilitates implementation of policies and procedures for CMO compliance, including development of quality agreements. Quality business processes and product disposition in accordance with team derived strategy and business realities. Perform batch record review and lot disposition activities as required Support internal and external audits as needed Create and revise standard operating procedures as needed Coach and mentor junior team members on a peer-to-peer level basis. Other duties as assigned. Qualifications & Requirements A minimum of BS/BA in a scientific disciplinary. 5+ years related industry experience with a minimum of 3 years' experience in quality assurance, quality control and compliance. Proven track record on investigations, deviations, change controls, product quality complaints and supplier qualification. Strong organizational skills, including ability to follow assignments through to completion. Knowledge of relevant regulations and guidance documents Strong decision-making capability and ability to ask compelling questions and to think strategically and understand global impact of decision Excellent verbal and written communication skills Detail-oriented with skills in problem solving and solid decision-making abilities Experience with working autonomously with proven ability to meet deadlines Proficient in the use of standard Microsoft Office software products, including Outlook, Word, and Excel required.
    $50k-79k yearly est. Auto-Apply 4d ago
  • Specialist Quality Assurance

    Us Tech Solutions 4.4company rating

    Quality systems specialist job in New Albany, OH

    + This position supports client's Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Product manufacturing areas. + The ideal candidate is a detail-oriented Quality Assurance professional with at least 2 years of GMP experience in a regulated manufacturing environment, preferably within pharmaceuticals or medical devices. + They should bring a solid understanding of QA documentation processes, including change controls, equipment qualifications, and master data approvals, and be comfortable working within SAP or EPR systems. + Strong project coordination skills and organizational discipline are essential, as this role supports a large-scale product launch and will require managing multiple deliverables on tight timelines. + A background in process development, manufacturing, or digital quality innovation is highly desirable. **Responsibilities:** + Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering staff in the execution of their processes, procedures, and use of quality systems. + Duties include presence on the shop floor, electronic batch record review, SOP revision approval, work order approval, and quality approval of minor deviations and CAPA records. + Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records, including Process and Equipment Validation Documents to completion. + The QA Specialist will also represent QA Functional area in the execution of projects necessary to achieve departmental operational goals. **Preferred Qualifications:** + Bachelor's Degree in Engineering, Biochemistry, Biology, Chemistry, or related science field. + Demonstrated ability to perform GMP operations including following detailed SOPS, maintaining training, and good documentation practices. + Experience managing projects through to completion meeting timelines. + Evaluating documentation and operations according to company procedures. + Experience working with Quality Systems Strong organizational skills and ability to manage multiple tasks at one time + Effective communication skills (both written and verbal). + Demonstrated ability to work as both a team player and independently. + Display leadership attributes and drive improvement initiatives. **Top 3 must have skills:** + Experience in and knowledge of GMP/GCP operations or similarly regulated industry + Affinity with digital innovation, data sciences and Quality engineering + Highly effective verbal and written communication skills, strong interpersonal skills + Great attention to detail and high degree of accuracy in task execution and GMP documentation + Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues. **About US Tech Solutions:** US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit *********************** . "US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"
    $47k-84k yearly est. 22d ago
  • Quality Assurance Specialist: Must have LMSW, PMHNP or MD

    Housing Works 4.3company rating

    Remote quality systems specialist job

    Must be a licensed Mental Health Professional (PHMNP), MD, or LMSW to be considered. If you are not a licensed New York State Psychiatric Nurse Practitioner, Medical Doctor, or Social Worker your application will not be accepted. Housing Works requires employees working in our Health Services division to be fully vaccinated against COVID-19, unless approved for a legal accommodation. If you need an accommodation for any reason, including related to this job requirement, please contact Human Resources. Job candidates should be aware that scammers may pose as employers and create fake job postings in order to extract personal information from individuals for financial gain. Housing Works will never ask job candidates for personal information, such as social security numbers or bank account details, over the phone. If you suspect that a job posting may be fake or wish to confirm that a job posting from Housing Works is genuine, please contact us at **************************** Housing Works was founded in 1990; With a long-term commitment to AIDS advocacy. Housing Works established New York State's first harm reduction-based, OASAS-licensed outpatient drug treatment program. Other services include Health Home care management, behavioral health, and syringe exchange programs. A pioneer in the social entrepreneurship movement, Housing Works operates 10 high-end thrift shops in Manhattan and Brooklyn and a much-loved Bookstore Cafe in Soho. For more information, visit ******************** Housing Works fights for funding and legislation to ensure that all people living with HIV/AIDS have access to quality housing, healthcare, HIV prevention, and treatment, among other lifesaving services. Benefits: We have three comprehensive healthcare plans to choose from based on your priorities and budget. Housing Works covers most of the plan; you pay a portion, based on your salary. Staff begins accruing PTO immediately for a total of up to 30 days earned in the first year. We offer employees an educational benefit. This money is available for tuition loan reimbursement, tuition costs, and text books. Housing Works provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements. Housing Works complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. Housing Works also does not request prior salary information during the hiring process. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Compensation Range: $25-$30 per chart review Summary: The Quality Assurance Specialist (QAS) supports a comprehensive quality assurance program for Housing Works' Behavioral Psychiatric programming to ensure operating regulations for services are in compliance with state agencies, funders, and providing quality clinical care, primarily through comprehensive chart reviews. In this regard, the QAS ensures that programs, services, and facilities meet minimum acceptable standards, as defined in statutes and regulations, and that appropriate managerial oversight of programs and services exist to reasonably assure efficient and effective delivery of intended programs and services to the public. The QAS may also work as a liaison to state agencies Technical Assistance Support to attain and maintain established standards, as well as efficient and effective management practices. This is a 100% remote position. Candidates must have an active behavioral health license in NY State. Eligible to obtain up to 18 free Social Work CEs per year through internal training offerings. Essential duties and responsibilities: Primary: Complete monthly chart reviews of Psychiatric Providers; amount each month may vary based on program enrollment and program needs. Ensure regulatory adherence to pre-admission and admission procedures, criteria set forth for continued stay, and required discharge procedures. Review and audit admission assessments. Review and audit in accordance with clinical quality indicators, such as provided diagnosis basis in current DSM, assessment of level of care, and other appropriate care/admission indicators. Ensure appropriate protocol for outpatient care is documented in accordance with state agency and Housing Works' guidelines. Audit completion and timely submission of clinical documentation within client's chart to follow state and/or internal agency regulatory standards. Provide clinical assessment based on chart review on program practices/implementation of admission/treatment/discharge processes and training requirements. Provide technical assistance to support improvement of program performance with compliance, including conducting in-service trainings to Psychiatric team members. Complete standardized review of Psychiatric Providers' compliance efficiency to utilize in assessing ongoing compliance of providers. Participate in agency and behavioral health departmental meetings that may be held on a weekly, bi-weekly, and/or monthly basis. This may include interdisciplinary and/or cross-departmental meetings. Identify challenges and shortcomings within clinical documentation that may influence corrective action steps geared towards improved adherence towards regulatory standards. Auditing data entry and generating reports as requested. Audit processes and report risk and/or billing issues in a timely manner. Secondary: Perform other duties and special projects as requested by supervisor. Participate in advocacy efforts and direct action to end the twin crises of homelessness and AIDS. Engage in monthly in-service training and other external trainings that are relevant to supporting or enhancing behavioral health program compliance. Minimum Requirements Must be a Licensed Qualified Health Professional (PHMNP), Licensed Master Social Worker (LMSW) or Licensed Medical Doctor (MD) Experience with diagnosis/treatment in an OASAS and/or OMH licensed program. Familiarity with OMH Regulations and UR Demonstrated experience in collaborative projects involving multiple project partners, possessing strong written and verbal communication skills, organizational skills, and demonstrated experience with working as a member of a team. Ability to present information in a one-on-one and small group situation. Proficient in Microsoft Office programs, particularly Excel and Word. The equivalent of two (2) years' experience in planning and coordinating quality assurance initiatives [preferred].
    $25-30 hourly Easy Apply 60d+ ago
  • QA Compliance Specialist

    Lancesoft 4.5company rating

    Quality systems specialist job in Columbus, OH

    The QA Compliance Specialist position exists to support the execution of quality & regulatory functions in the organization to ensure compliance with the AV-SH quality/business systems to applicable regulations, standards and corporate policies. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Support external audit activities (FDA, FDB, ISO registrar audits etc.). Audit areas of client s Vascular Quality System. Support administration of Quality System processes (CAPAs, Internal Audits etc.). Generate and distribute periodic open CAPA and Internal Audit Corrective Action (IACA) reports. Track and trend compliance activities on a periodic basis. This may include CAPA & IACA metrics etc. Generate compliance metrics for Management Reviews. Assist the organization to receive timely feedback on open corrective actions. Participate in cross divisional activities to integrate quality system information. Conduct review and update Quality System procedures as necessary. Assist in developing & conducting Quality System training as necessary. File Quality Records (audit reports, IACAs, CAPAs etc.). Ensure that all responsibilities are carried out in compliance with governing regulations and standards. Other duties as assigned. Education: Bachelor Degree or equivalent plus 4 + years of related work experience or equivalent combination.
    $69k-90k yearly est. 26d ago
  • Freelance Chemistry Expert - Quality Assurance (AI Trainer)

    Mindrift

    Remote quality systems specialist job

    This opportunity is only for candidates currently residing in the specified country. Your location may affect eligibility and rates. Please provide your resume in English and specify your proficiency level. At Mindrift, innovation meets opportunity. We believe in using the power of collective intelligence to ethically shape the future of AI. What we do The Mindrift platform connects specialists with AI projects from major tech innovators. Our mission is to unlock the potential of Generative AI by tapping into real-world expertise from across the globe. About the Role Generative AI models are improving very quickly, and one of our goals is to make them capable of addressing specialized questions and achieving complex reasoning skills. The QA role involves evaluating complex question-answer pairs written by our experts and create scoring criteria (rubrics) to evaluate and grade the quality of responses. This role includes the following responsibilities: Content Creation & Refinement: Create and refine content to ensure accuracy and relevance across a variety of topics in Biology, while also developing references and examples of tasks. Experts Acquisition: Assess qualification tests of experts, ensuring their competency. Chat Moderation: Provide support by addressing project-related questions from other experts in Discord chats, especially those related to project guidelines. Auditing Work: Review and evaluate tasks completed by AI Trainers, ensuring they align with project guidelines. Provide constructive feedback, verify expertise-related information, and edit content as necessary to improve quality. How to get started Simply apply to this post, qualify, and get the chance to contribute to projects aligned with your skills, on your own schedule. From creating training prompts to refining model responses, you'll help shape the future of AI while ensuring technology benefits everyone. Requirements You hold a Master's or PhD Degree in Chemistry or a related field. You have at least 6 years of professional experience. Your level of English is advanced (C1) or above. Working experience with Python. You have experience in writing or evaluating complex LLM prompts. You have experience in Teaching/Lecturing/Consulting in your domain. You are ready to learn new methods, able to switch between tasks and topics quickly and sometimes work with challenging, complex guidelines. Our freelance role is fully remote so, you just need a laptop, internet connection, time available and enthusiasm to take on a challenge. Benefits Why this freelance opportunity might be a great fit for you? Get paid for your expertise, with rates that can go up to $55/hour depending on your skills, experience, and project needs. Take part in a part-time, remote, freelance project that fits around your primary professional or academic commitments. Work on advanced AI projects and gain valuable experience that enhances your portfolio. Influence how future AI models understand and communicate in your field of expertise.
    $32k-54k yearly est. Auto-Apply 57d ago
  • Quality Assurance Specialist

    ABC Legal Services 4.1company rating

    Remote quality systems specialist job

    ABC Legal Service is proud to be the national leader in service of process. We are growing and are looking for talented new team members to support our growth and solve exciting challenges! We are a team of over 400 with offices in Los Angeles, Phoenix, Oklahoma City, Brooklyn, Chicago, and more. Seattle is our home and headquarters. We've been successful in this unique business for over 30 years and we continue to advance our technology and business processes to remain years ahead of what our competition is able to offer. Job Overview: As a Quality Assurance Specialist, you will ensure that ABC is working with the best process servers out there. Your role will focus on coaching, training, and providing feedback to make our process servers as successful as possible. Key Responsibilities: Provide support, training and education to process servers that are underperforming based on key metrics Create positive and engaging server experience for all underperforming process servers: Communicate directly with process servers providing coaching and meaningful feedback Field all questions from process servers and resolve blockers Ensure process servers understand expectations and the timeframe in which they need to adjust. Set clear expectations for underperforming servers Review assigned reports daily, reach out to disengaged servers to identify and resolve the reasons they are not attempting jobs timely. Hold Servers accountable to directly impact performance Track and communicate all blockers to the leadership team Work closely with the recruiting department when additional coverage is needed Qualifications: Experience training and/or coaching High school diploma or GED required Familiarity with Legal Processes is a plus Excellent written and verbal communication skills Experience and proficiency with Microsoft Office (Word, Excel) The ability to analyze processes and make recommendations for improvements We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. Join our team today! Comprehensive Medical, Dental, and Vision coverage Competitive salary package 401(k) retirement plan with 5% matching Orca Card / Transit Stipend 10 paid holidays per year Referral program Work from home flexibility Pay Range: $15.00 to $17.00 per hour Schedule - Full-Time, Monday through Friday, 9am to 5pm PST
    $15-17 hourly Auto-Apply 60d+ ago

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