Quality assurance specialist jobs in Ohio - 697 jobs

Kelly Science & Clinical is seeking a Senior Quality Assurance Coordinator near Cincinnati, OH. Direct Hire Shift: Monday - Friday 8am-5pm Compensation: DOE Reporting directly to the Senior Manager, Total Quality, the Quality Assurance Senior Compliance Coordinator will provide support to the Corporate Quality team by ensuring the company's policies and practices meet regulatory requirements in a food, cosmetic, and pharmaceutical environment. The QA Senior Compliance Coordinator will be working directly with customers to complete or approve the customers' regulatory product documentation including customer quality questionnaires about the company, product quality statements, process procedures, product stability study reports, etc. This person will control, organize and maintain proprietary documentation for the company and customers. They will manage and maintain new QMS software system relative to position. The position utilizes extreme attention to detail to ensure that the documents reflect our quality program. The QA Senior Compliance Coordinator will also support the organization in other corporate quality programs including: quality internal and external auditing, document technical writing, product qualification practices, document control, quality and employee training. This position will work with all levels of management and associates to facilitate problem-solving and ensure customer and regulatory quality standards are achieved. RESPONSIBILITES Completion and approval of customer quality documentation for site and product qualification (ie. Customer surveys, questionnaires). Creation and/or editing of product documents, procedures, supplier or service quality agreements, and other support materials. Produce electronic documentation in addition to hard copy manuals. Develop and maintain an electronic reservoir of up-to-date supplier product information. Maintain an organized filing system of original hard copy documents. Provide Corporate QA support to other CNA sites with customer complaints, investigations and reporting as requested. Navigate daily through customer specific software programs to update company's specifications and product information. Ensure any quality software / electronic software systems are compliant with current regulations. Support Document Control program at all Company sites by reviewing, revising, and publishing procedures or forms. Route and obtain the specific approvals needed through electronic signature or manual wet signatures. Perform administrative functions to support the team including, preparing reports, document filing, proofreading, audit / meeting notetaking, and correspondence. Provide training and education of the quality management system and practices to personnel as required for operational readiness activities. Work independently on assigned projects and daily QA maintenance functions. Serve as quality lead on the development and maintenance of Quality Management Systems (QMS) based on company's global standards and regulations by collecting and analyzing data. Support on-site audits from customers and regulatory by taking notes in audits, preparing the audit response to customer, and providing supporting documentation. Complete assigned external audits with formal audit reports within a timely manner. Participates in Kaizen events, huddles, quality/safety walks, internal auditing, investigations, and 5S best practice events. Ensures that actions items are completed in a timely manner. Perform other administrative and quality assurance duties as assigned. KNOWLEDGE, SKILLS & ABILITIES Attention to Detail Organizational skills Good communication skills - verbal and written. Excellent time management. Self-motivation, initiative Critical thinking. Working well independently as well as in a team. Being flexible. Determination and persistence. Being a quick learner. Project management skills MINIMUM REQUIREMENTS Bachelor's degree or related discipline or equivalent combination of experience and education preferred. At least 4 years of progressive experience in a GMP manufacturing and / or laboratory environment. Worked in a GMP and ISO environment. Must have prior experience in a Quality Assurance role with knowledge of GDP requirements. GMP, GFSI, or ISO Certified Quality Auditor (ie ASQ). Able to perform supplier and service audits and write audit reports on behalf of company when needed. Familiar with customer and regulatory audits for excipients and pharmaceuticals, a plus. Internal Auditor certified. (ie. ISO 19011) Intermediate computer literacy and software applications. Strong Computer skills of MS Office Suite, Quality Management Software (QMS) or Laboratory Management systems (LMS) systems. Experience in an ERP system, or Sharepoint software a plus. This position involves creating company platforms within a variety of customer specific software and data processing systems. Proven Project Management skills. Able to present quality topics & learnings in large group settings. Proven technical writing skills and attention to detail in a scientific environment warranting such skills. Strong working knowledge of editing, proofreading, spelling, grammar, and punctuation. Skilled at organizing information into a clear and concise written form. Ability to work independently as well as in a team environment. Physical Requirements: Up to 20% of travel time. Position is in office setting, open environment. Activities can be routine, repetitive. Prolonged periods sitting at a desk and working on a computer. Ability to see and distinguish color. Lift up to 25 lbs. occasionally. Bend, stoop, carry. Repeating motion that may include wrists, hands, and fingers. PERFORMANCE MEASURES AND STANDARDS Attention to detail and organization skills. Meet established deadlines internally and with customers. Must be able to work quickly with a high degree of accuracy. Proven, professional technical writing skills. Demonstrate strong planning skills and initiative to manage a fluctuating workload while supporting the Corporate QA team. Maintain and monitor the Customer database systems to review, complete, and close items on behalf of company within a timely manner. Maintain and monitor the company's Quality software database system (IQS) to review, approve and close items on behalf of Corporate Quality Assurance. Complete assigned audits and final reports in a timely manner. Ensures 100% compliance with the governmental and local regulations Arrange personnel coverage in the event of absence. Provides documented communication with specified customers. Adhere to all Environmental, Health, Safety, Security Requirements covered under Local State and Federal Regulations. Follow all ISO 14001, ISO 9001 and HACCP guiding principles, policies, procedures, and other requirements.

The Quality Assurance Lead is a pivotal role within the production department, ensuring that all products meet the highest quality standards. This individual will lead a team of QA professionals, oversee the implementation of quality assurance polici Quality Assurance, Assurance, QA, Leadership, Lead, Manufacturing, Business Services, Quality

Employment Status: Salary Full-Time Function: Quality Assurance/Control Pay Grade and Range: US10-E-26 (Min $52,300 - Mid $66,700$52,300.00 - $81,100.00) Bonus Plan: Profit SharingProfit Sharing Target Bonus: Hiring Manager: Steven Slover Recruiter: Allison Schock Internal Candidate Eligibility Criteria: 1. Is a Lincoln Electric employee with at least 1 year of service 2. Is NOT on an active Performance Improvement Plan (PIP) Purpose The QA Technologist provides operational support and drives quality initiatives within the Euclid Consumable Division. This role ensures that process audits, inspection, and testing procedures are well-defined and contribute to continuous improvement in quality. The QA Technologist will manage warranty systems, review customer warranties, enhance the non-conformance process, and implement corrective action requests. Long Description Troubleshoot and resolve quality issues across Consumable products. Develop, document, and maintain procedures for daily quality operations. Establish and support training programs for QA technicians. Support and continuously improve the Non-Conformance system. Manage customer-facing issues through the Warranty System. Issue and maintain stop-ship actions, and drive improvements to the stop-ship process. Leverage data from quality systems to enhance visibility, streamline actions, identify trends, and improve overall quality performance. Collaborate cross-functionally with Customer Service, Methods, Plant Engineering, R&D, and Specials to drive continuous improvement initiatives. Support certification reviews and approvals. Assist in developing and maintaining quality process control methodologies. Utilize computers, databases, and software tools associated with the Quality Program. Basic Requirements Bachelor's degree in Engineering Technology or related field, or equivalent experience. Minimum 2 years (Level I Technician) of related experience (5+ years preferred Level III Technician) Preferred knowledge of welding processes (GMAW, FCAW, GTAW, SAW). Ability to interpret technical drawings and work instructions. Strong analytical and problem-solving skills. Proficiency in Microsoft Office and quality-related software tools Lincoln Electric is an Equal Opportunity Employer. We are committed to promoting equal employment opportunity for applicants, without regard to their race, color, national origin, religion, sex (including pregnancy, childbirth, or related medical conditions, including, but not limited to, lactation), sexual orientation, gender identity, age, veteran status, disability, genetic information, and any other category protected by federal, state, or local law.

The Quality Analyst III is responsible for analyzing and interpreting complex healthcare data. This role will collaborate with cross-functional teams, providing analytical insight to inform strategy and interventions to drive improved quality performance Essential Functions: Generate comprehensive reports, graphics and dashboards that effectively summarize and display data for key stakeholders Review reports and data for pattern identification, special cause variation identification, trend analysis, or other techniques and provide management level summaries that explain key findings Provide technical expertise and guidance to team members on SQL, SAS, and DAX coding best practices, visualizations, and table locations Interpret and maintain understanding of technical specification and other quality reporting requirements and ensure any changes are implemented and communicated with key stakeholders timely Interact and work collaboratively with business partners on analysis, reports and data patterns to identify trends Gather, understand and refine requirements for analytics requests including but not limited to HEDIS, Population Health, Pharmacy Quality, Accreditation, Health Equity, business development and RFP requests Collaborate with IT teams to enhance data collection and reporting systems Perform any other job duties as assigned Education and Experience: Bachelor of Science/Arts degree in Management Information Systems (MIS), computer science or related field or equivalent work experience is required Master of public health (MPH), Business Administration (MBA), mathematics, statistics, or related field is preferred Minimum of three (3) years of experience in data analysis and/or analytic programming is required Minimum of three (3) years of HEDIS or similar healthcare quality performance metrics experience is required 3-5 years Programming experience (i.e., SQL, SAS) is required Programming in DAX/Power BI is preferred Health care delivery, clinical experience and/or payer experience is preferred. Competencies, Knowledge, and Skills: Intermediate proficiency level with Microsoft Office Suite Complex problem-solving skills for solving multi-dimensional business questions Proficient in Programming language (i.e., two of SQL, SAS and/or DAX) is required Managed Care Organization knowledge and familiarity Graphic development & presentation skills Exposure to statistical concepts strongly preferred Critical thinking and active listening skills Effective verbal and written communication skills Ability to lead analytic efforts Ability to serve as liaison with business partners Knowledge of managed care and health care data coding Ability to interface with IT teams, familiarity with MDS and advanced data architecture Licensure and Certification: None Working Conditions: General office environment; may be required to sit or stand for extended periods of time Compensation Range: $72,200.00 - $115,500.00 CareSource takes into consideration a combination of a candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required for the role, and other external and internal data when establishing a salary level. In addition to base compensation, you may qualify for a bonus tied to company and individual performance. We are highly invested in every employee's total well-being and offer a substantial and comprehensive total rewards package. Compensation Type: Salary Competencies: - Fostering a Collaborative Workplace Culture - Cultivate Partnerships - Develop Self and Others - Drive Execution - Influence Others - Pursue Personal Excellence - Understand the Business This is not all inclusive. CareSource reserves the right to amend this job description at any time. CareSource is an Equal Opportunity Employer. We are dedicated to fostering an environment of belonging that welcomes and supports individuals of all backgrounds. #LI-GB1

Crown Equipment Corporation is a leading innovator in world-class forklift and material handling equipment and technology. As one of the world's largest lift truck manufacturers, we are committed to providing the customer with the safest, most efficient and ergonomic lift truck possible to lower their total cost of ownership. Job Posting External Job Duties Trade Compliance Administration and Metrics - Develop and create performance metrics for agents, brokers, forwarders, and internal departments. Complete, correct, and ensure accurate HTS and ECCN classifications and recordkeeping. Utilize regulatory knowledge to determine country of origin for Company produced materials and recommend marking for same. Investigate restricted party screening for recommendation to management or legal. Calculate and prepare US Customs reconciliation for submission. Submit electronic filings with US Government entities and CTPAT supply chain security program. Manage qualification process for FTA and programs including Buy American to certify and ensure appropriate and accurate recordkeeping. Author protests for submission to US Customs and Border Protection Agency for relevant import entries. Research product scope, qualification, or inclusion in programs including Antidumping and Countervailing duties, and Partner Government Agency entry filing. Internal Audits and Report Results - Conduct internal audits of classifications, origin, trade programs, policies, procedures, CTPAT Security Criteria and transactional documents to identify risks. Compile audit results, provide recommendations, and coordinate corrective action to completion. Ensure questions, concerns, and requests for support/help are addressed and documented. Prepare export license applications. Complete corrections to documents or entries and maintain audit trail. Policies and Procedures - Research laws, regulations, and best practices to support Company's trade compliance programs. Interface with Company's international locations and functions to ensure alignment of trade procedures. Assist the development and administration of trade compliance policies, procedures, and periodic management reviews. Develop and facilitate training to address specific functions for current or newly hired employees. Leadership and Development - Assist in developing and coaching team members. Provide leadership to Support and Specialist personnel as subject matter expert in department. Monitor educational courses in supply chain security and international trade to ensure Company personnel receive appropriate education and experience. Lead training sessions for Trade department and service providers. Minimum Qualifications 5-7 years related experience Bachelor's degree (Business or Supply Chain) Non-degree (12+ years of related experience and high school diploma/GED) Frequent travel & Frequent overnight stays (6-20%) Preferred Qualifications Possess US Customs Brokers License or obtain within a year of hire. Experience with project management. Good interpersonal skills, professionalism, leadership,management and customer service skills. Able to organize conferences, speak in front of groups and provide educational classes on various topics. Work as a contributing team member on cross-functional and global teams and successfully interact with various government agencies. Work Authorization: Crown will only employ those who are legally authorized to work in the United States. This is not a position for which sponsorship will be provided. Individuals with temporary visas or who need sponsorship for work authorization now or in the future, are not eligible for hire. No agency calls please. Compensation and Benefits: Crown offers an excellent wage and benefits package for full-time employees including Health/Dental/Vision/Prescription Drug Plan, Flexible Benefits Plan, 401K Retirement Savings Plan, Life and Disability Benefits, Paid Parental Leave, Paid Holidays, Paid Vacation, Tuition Reimbursement, and much more. EOE Veterans/Disabilities

Why E2 Optics? 🔌 Join Our Team as a QA/QC Coordinator at E2 Optics! 🔌 Are you ready to elevate your career with an award-winning, Woman-Owned technology integrator that's leading the charge in the data center revolution? E2 Optics is one of the fastest-growing and most stable companies at the core of the tech industry-powering the infrastructure behind AI, cloud computing, and the innovations of tomorrow. At E2 Optics, you will work with cutting-edge systems in some of the most advanced environments in the world. We invest in your growth through hands-on experience, industry certifications, and leadership opportunities that put you in charge of teams and outcomes. Collaboration is in our DNA-we believe in lifting each other up, mentoring with purpose, and celebrating every win. If you're looking to be part of something meaningful, fast-moving, and future-focused, your next opportunity is here. Join one of America's largest and fastest-growing tech integrators and help us shape what's next. What You'll Do Safety is E2 Optics' number one Core Value. All employees are expected to follow safe work practices, as well as adhere to company and client worksite safety policies and procedures. Safety First: Comply with worksite safety standards and promote safety within the team. Quality Assurance: Develop and execute the E2 Optics Quality Management System (QMS) for every project. Collaboration: Partner with internal and external stakeholders to ensure adherence to quality standards. Inspections & Reporting: Conduct quality inspections, generate data analytics, and track nonconformance reports. Continuous Improvement: Drive Lean initiatives and contribute to the success of quality-driven projects. Training & Coaching: Train internal teams on quality standards and procedures. What We Are Looking For High school diploma or GED required. 2+ years of field experience with structured cabling or data center cabling installations. Experience with fiber installation and testing. Strong communication and coaching abilities. Analytical, decision-making, and problem-solving skills. Proficient in Microsoft Office (Outlook, Word, Excel). Ability to work under pressure while maintaining a positive, detail-oriented approach. Experience with technical writing and developing QA/QC procedures is a plus. What We Offer Competitive pay Opportunities for professional development and career growth BICSI training facilities A supportive and inclusive work environment Health, dental, and vision insurance Paid time off and holidays Work Environment and Physical Demands The standard work environment for this position is an indoors business office and construction environment. The noise level in the work environment is usually moderate. While performing the duties of this job, the employee is regularly required to sit, talk or hear, use hands, stoop, kneel, reach with hands and arms, and talk or hear. The employee is frequently required to stand and walk. The employee must regularly lift and/or move up to 50 pounds and frequently lift and/or move up to 25 pounds. The employee must regularly carry and climb ladders to 20 feet. Must be able to operate equipment such as scissor lifts, telehandlers, boom lifts, and UTVs (buggies) if required to do so. The employee may also be required to work in tight, confined spaces. The physical demands described here are representative of those that must be met to successfully perform the essential functions of this job. When possible, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Disclaimer The above job definition information has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Job duties and responsibilities are subject to change based on changing business needs and conditions.

FLSA Status: Non-Exempt Reports To: Quality Assurance Manager Job Summary: The Quality Assurance Assistant supports the quality assurance team in ensuring that products and services meet established standards. This role involves assisting with quality control processes, maintaining documentation, and supporting continuous improvement initiatives. Essential Duties and Responsibilities: Assist in the development and implementation of quality assurance policies and procedures. Conduct inspections and audits to ensure compliance with quality standards. Maintain accurate records of quality inspections, audits, and corrective actions. Support the quality assurance team in identifying and resolving quality-related issues. Assist in the preparation of quality reports and documentation. Participate in continuous improvement initiatives to enhance product quality and operational efficiency. Provide administrative support to the quality assurance team as needed. Ensure compliance with industry regulations and standards. Qualifications: Associate's degree in Quality Management, Engineering, or a related field preferred. Minimum of 1 year of experience in quality assurance or quality control. Strong attention to detail and organizational skills. Proficiency in Microsoft Office Suite and quality management software. Good communication and teamwork skills. EEO Statement: [Company Name] is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Job Description FLSA Status: Non-Exempt Reports To: Quality Assurance Manager Job Summary: The Quality Assurance Assistant supports the quality assurance team in ensuring that products and services meet established standards. This role involves assisting with quality control processes, maintaining documentation, and supporting continuous improvement initiatives. Essential Duties and Responsibilities: Assist in the development and implementation of quality assurance policies and procedures. Conduct inspections and audits to ensure compliance with quality standards. Maintain accurate records of quality inspections, audits, and corrective actions. Support the quality assurance team in identifying and resolving quality-related issues. Assist in the preparation of quality reports and documentation. Participate in continuous improvement initiatives to enhance product quality and operational efficiency. Provide administrative support to the quality assurance team as needed. Ensure compliance with industry regulations and standards. Qualifications: Associate's degree in Quality Management, Engineering, or a related field preferred. Minimum of 1 year of experience in quality assurance or quality control. Strong attention to detail and organizational skills. Proficiency in Microsoft Office Suite and quality management software. Good communication and teamwork skills. EEO Statement: [Company Name] is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Tuesday - Friday, 1:00pm - 11:30 pm. Overtime as needed.

FLSA Status: Non-Exempt Reports To: Quality Assurance Manager Job Summary: The Quality Assurance Assistant supports the quality assurance team in ensuring that products and services meet established standards. This role involves assisting with quality control processes, maintaining documentation, and supporting continuous improvement initiatives. Essential Duties and Responsibilities: Assist in the development and implementation of quality assurance policies and procedures. Conduct inspections and audits to ensure compliance with quality standards. Maintain accurate records of quality inspections, audits, and corrective actions. Support the quality assurance team in identifying and resolving quality-related issues. Assist in the preparation of quality reports and documentation. Participate in continuous improvement initiatives to enhance product quality and operational efficiency. Provide administrative support to the quality assurance team as needed. Ensure compliance with industry regulations and standards. Qualifications: Associate's degree in Quality Management, Engineering, or a related field preferred. Minimum of 1 year of experience in quality assurance or quality control. Strong attention to detail and organizational skills. Proficiency in Microsoft Office Suite and quality management software. Good communication and teamwork skills. EEO Statement: [Company Name] is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

FLSA Status: Non-Exempt Reports To: Quality Assurance Manager Job Summary: The Quality Assurance Assistant supports the quality assurance team in ensuring that products and services meet established standards. This role involves assisting with quality control processes, maintaining documentation, and supporting continuous improvement initiatives. Essential Duties and Responsibilities: Assist in the development and implementation of quality assurance policies and procedures. Conduct inspections and audits to ensure compliance with quality standards. Maintain accurate records of quality inspections, audits, and corrective actions. Support the quality assurance team in identifying and resolving quality-related issues. Assist in the preparation of quality reports and documentation. Participate in continuous improvement initiatives to enhance product quality and operational efficiency. Provide administrative support to the quality assurance team as needed. Ensure compliance with industry regulations and standards. Qualifications: Associate's degree in Quality Management, Engineering, or a related field preferred. Minimum of 1 year of experience in quality assurance or quality control. Strong attention to detail and organizational skills. Proficiency in Microsoft Office Suite and quality management software. Good communication and teamwork skills. EEO Statement: [Company Name] is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Nature and Scope This position is a member of the Quality Assurance team. This position is responsible for ensuring the overall Quality in their assigned areas through the execution of site policies and procedures, programs and work instructions. Ensures all processes and products meet specifications and that products are produced in accordance with GMP requirements. This position is responsible for participating in material receipt, then coordinating sampling and inspection for components, in a sterile manufacturing facility. This position is responsible for ensuring the overall Quality of materials as assigned by Quality Management in coordination with other stakeholders such as Materials Management and Operations, etc. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. * Responsible for execution of procedural documentation as they pertain to various aspects of the receiving and sampling processes. * Performs sampling of components. * Conduct verifications and checks through accurate material inspections. * Identify out of specification materials ensuring segregation and escalation, and perform any activities required within the Trackwise Events system * Management of BPCS for verification and disposition of materials * Maintain retain samples for all primary and secondary components and labeling * Performance of DAF (Destruction Approval) process for rejected materials * Use of Trackwise and Veeva for change controls, as needed * Ensure errors and omissions are resolved according to Standard Operating Procedure (SOP) requirements * Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, health and safety requirements. * Ensure all components and raw materials are appropriately prepared for the applicable status disposition, including all relevant documentation. * Support generation of logbooks and sheets/labels as required. * Basic knowledge of cGMPs and supporting regulatory documents * Perform room, area and equipment clearances that may be necessary for this job function. * Able to perform tasks with minimal error rate. * Assist other Quality Assurance Operations Associates, as needed. * Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. * High School Diploma or GED equivalent required. Associates or Bachelor's Degree preferred. * At least two (2) years of related experience (QA, Compliance, Auditing, Laboratory or Inspection, within a GMP environment) preferred. * Must be able to do work independently. * Experience in QA working in a cGMP manufacturing environment (preferred) * Working knowledge and understanding of quality assurance principles and familiarity with QA programs * Strong analytical skills, attention to detail and adherence to procedures. * Intermediate skills in Microsoft Word and Excel are required. * Excellent organizational, interpersonal and communication skills (written and oral) required. * Ability to take feedback constructively and function in a team-oriented work environment. * Ability to work overtime as needed. Physical Environment and Requirements * Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. * Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision. * Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly. Employee must be able to occasionally lift and/or move up to 25 pounds. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. * FMLA poster: ********************************************************** * Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) * Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: * All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. * Our recruiting process includes multiple in person and/or video interviews and assessments. * If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. * We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. 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What Makes a Honda, is Who makes a Honda Honda has a clear vision for the future, and it's a joyful one. We are looking for individuals with the skills, courage, persistence, and dreams that will help us reach our future-focused goals. At our core is innovation. Honda is constantly innovating and developing solutions to drive our business with record success. We strive to be a company that serves as a source of “power” that supports people around the world who are trying to do things based on their own initiative and that helps people expand their own potential. To this end, Honda strives to realize “the joy and freedom of mobility” by developing new technologies and an innovative approach to achieve a “zero environmental footprint.” We are looking for qualified individuals with diverse backgrounds, experiences, continuous improvement values, and a strong work ethic to join our team. If your goals and values align with Honda's, we want you to join our team to Bring the Future! JOB PURPOSE The Lead Auditor / Quality Management System (QMS) Specialist is responsible for the overall facility internal auditing activities. The Lead Auditor / QMS Specialist all QMS and Audit related activity for the facility, while consulting and advising departments and ACIE / CIE / Top Leadership on QMS gaps and/or improvements by summarizing and reporting QMS / Audit activity on a regular basis. This role supports the N.A. QMS Committee and represents the facility as an ISO SME/QMS. Additionally, this role also interfaces with the Global Honda QMS (G-HQS) committee as well as the Japan Quality Compliance and Audit Division (QCAD) for QMS compliance and monitoring of the internal audit program results. KEY ACCOUNTABILITIES QMS Related: Lead / Assist development and maintenance of the Russells Point, Ohio facility level procedures (QAPs). Lead training activities for QMS related items within the Russells Point, Ohio facility. Support the NA Quality Committee for the development and implementation of the Honda North American Quality Manual and supplements as the Russells Point, Ohio facility Lead. Serve as the facility administrator for DocuQuest, PeopleQuest, AuditQuest and RecordQuest. Support development, implementation, and maintenance of the quality management system based on ISO 9001, G-HQS, NA QMS and local QMS requirements. Auditing Related: Serve as the ISO 9001 Lead Auditor for Russells Point, Ohio facility. Co-Lead for External audits of ISO 9001 Certification Registrars and support Regional N.A. or HDMA audits as requested. Issue Internal audit plans, conduct audits per the approved audit plan, and issue audit reports, obtaining all required approvals and maintaining the records for the completed internal audits Review and support the evaluation of Root Cause Analysis, Temporary and Permanent Countermeasures proposed from departments where gaps are identified and confirm their effectiveness at planned intervals. Support development, training, and management of the internal auditing team for ISO 9001 Support the development of the overall internal audit program as well as the training and management of the internal auditing team for ISO 9001. Reporting Related: Liaison and Support to the PUO CIE and/or TMP-OH ACIE's, providing updates related to the health of the Quality Management System, including the implementation of continual improvement objectives Co-lead QMS Committee Meetings monthly on the Local Level, provide facility updates of Procedural Changes, facility specific activity and promote the incorporation of new ideas for continual improvement Provide weekly audit finding status updates to Top Management during weekly quality meetings Carry out special projects/tasks as assigned by Leadership such as special audit items, BOP Theme activity, etc., as needed QUALIFICATIONS Bachelor's Degree or equivalent experience (relevant manufacturing, quality, and auditing experience) Internal Auditor Certification (Lead Auditor Certification preferred) 2-6 years of manufacturing / quality experience, including minimum of 1 year of related QMS and/or auditing experience. Knowledge of Honda's Computer/Web-based systems (MS Office/Teams, IntellaQuest etc.) Knowledge of Honda's Business Plan and Theme activity Knowledge of Honda's Quality Management System (QMS) Knowledge of Honda's SEQCDM guidelines / requirements within area of responsibility Highly motivated with positive, strong work ethic and initiative with the ability to self-learn Solid communication and presentation skills with the ability to share information and interact with multiple departments Ability to prepare information and present to large groups, including various levels of associates up to Top Leadership Excellent time management and organization skills with the ability to multi-task Flexibility and adaptability to respond quickly and effectively to rapidly changing priorities and/or special requests Effective leadership skills, with the ability to work in Teams and lead special projects cross functionally Strong critical thinking skills and problem-solving methodology Demonstrate the initiative and ability to make solid decisions under pressure WORKSTYLE This position works in an open office environment and requires primarily desk work, including frequent meetings, as well as occasional production floor visits for audit related activity. Travel may be necessary for NA QMS Committee Quarterly meetings and/or travel to other plants for QMS Audit support. OT necessary to complete task deadlines for BOP/Theme scorecards as well as occasional Teams meetings with Japan QCAD or internal plant meetings related to Audit activity/reporting to meet necessary NCR deadlines. What differentiates Honda and make us an employer of choice? Total Rewards: Competitive Base Salary (pay will be based on several variables that include, but not limited to geographic location, work experience, etc.) Paid Overtime Regional Bonus (when applicable) Industry-leading Benefit Plans (Medical, Dental, Vision, Rx) Paid time off, including vacation, holidays, shutdown Company Paid Short-Term and Long-Term Disability 401K Plan with company match + additional contribution Relocation assistance (if eligible) Career Growth: Advancement Opportunities Career Mobility Education Reimbursement for Continued Learning Training and Development programs Additional Offerings: Tuition Assistance & Student Loan Repayment Lifestyle Account Childcare Reimbursement Account Elder Care Support Wellbeing Program Community Service and Engagement Programs Product Programs Honda is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, veteran status, or any other protected factor.

The successful candidate will be responsible for facilitating the management of sponsor audits, and facilitating QA relationship with external clients. The position will also include conducting inspection readiness activities for Medpace and Medpace stakeholders. Responsibilities * Facilitating Medpace sponsor audits onsite; * Review and assess responses to sponsor audit reports; * Provide clarity to the Quality Management System (QMS) during sponsor audits and other external audits; * Provide guidance to Medpace study teams during sponsor audits; and * Manage pre-inspection activities for Medpace inspections. Qualifications * Bachelor's degree in life science or a related field; * Experience in conducting and supporting regulatory inspections is a plus (FDA, MHRA and EMA); * Strong communication skills; * Strong quality mindset; * Excellent written and verbal communications skills; * Independent thinking and planning ability; * Experience with a wide range of computerized systems; * Good time management skills; * Ability to switch between both big picture view and attention to detail; * The ability to work well on a team as well as independently. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

DSV - Global transport and logistics In 1976, ten independent hauliers joined forces and founded DSV in Denmark. Since then, DSV has evolved to become the world's 3rd largest supplier of global solutions within transport and logistics. Today, we add value to our customers' entire supply chain by transporting, storing, packaging, re-packaging, processing and clearing all types of goods. We work every day from our many offices in more than 80 countries to ensure a steady supply of goods to production lines, outlets, stores and consumers all over the world. Our reach is global yet our presence is local and close to our customers. Read more at *********** Location: USA - Canal Winchester, Robinette Way Division: Solutions Job Posting Title: Quality Assurance Assistant (1st Shift -Mon-Fri-6:00 am-2:30 pm Time Type: Full Time Position Description Summary: Responsible for ensuring accurate centralized data capture. Responsible for performing product inspection and audits of quality control programs. Perform shipping distribution inspections, and sampling and testing operations. May assess draft and final label copy, utilizing knowledge of labeling regulations. Minimizes down time by reducing production rework and recalls. Principal Accountabilities (The following is intended to describe the general nature and level of work being performed. It is not an exhaustive list of all expectations.): * Advise operators on escalation procedures * Responsible for the documentation of inbound and trailer defects (photos, initial report, enter data into Damage Reduction Database, emails to appropriate distribution lists) * Report and follow-up on all inbound and trailer defects (return, rework, accessorial) * Distribute WPPS and procedure updates * Shift training on Quality, rework projects, standard updates & procedure updates * Assist in managing rework projects * Safety Liaison - incident reporting, follow-up, investigations * Perform quality checks * Release product when required * Perform root cause analysis and action plans for QIs * Acts as a contact for Pest Control in lieu of Quality Manager * Shift Audits * Monitor operators for compliance with standard * Maintains a clean and safe work environment * Follows all SOP and safety guidelines * Maintains a high level of quality in work performed * Performs other duties as assigned The individual in this position must be capable of performing all of the essential functions with or without a reasonable accommodation. Working Environment: Assignment Complexity - Work on assignments that are complex in nature where considerable judgment and initiative are required in resolving problems and making recommendations. Accountability - Use ability as a skilled specialist in accordance with corporate policies and procedures to complete complex tasks in creative and effective ways. Impact of Decisions - Errors detectable upon supervisory review. Identifiable impact on corporate operations and fiscal health. Working Relationships - Regularly interact with peers and management concerning matters of complex scope and discretion. Scope - Work on problems complex in scope. May determine methods and procedures on new assignments and may provide guidance to other nonexempt personnel. Essential Functions: Must be able to pass any federal/state/local government, airport, or company-required background checks, clearances, and/or drug and alcohol tests. Knowledge and Skills (The following minimum requirements are normal guidelines and should not constrain the advancement of otherwise qualified personnel): This is a senior level position. Proficient in MS Office. Effective written and oral communication skills required. Good interpersonal skills required. High school diploma or equivalent required. Generally prefer 3-6 years of experience. DSV is an equal employment opportunity employer. Candidates are considered for employment without regard to race, creed, color, national origin, age, sex, religion, ancestry, disability, veteran status, marital status, gender identity, sexual orientation, national origin, or any other characteristic protected by applicable federal, state or local law. If you require special assistance or accommodation while seeking employment with DSV, please contact Human Resources at *************. If you are interested in learning the status of your application, please note you will be contacted directly by the appropriate human resources contact person if you are selected for further consideration. DSV reserves the right to defer or close a vacancy at any time. DSV - Global transport and logistics Working at DSV means playing in a different league. As a global leader in transport and logistics, we have been on an extraordinary journey of growth. Let's grow together as we continue to innovate, digitalise and build on our achievements. With close to 160,000 colleagues in over 90 countries, we work every day to offer solid services and meet our customers' needs and help them achieve their goals. We know that the best way to achieve this is by bringing in new talent, fresh perspectives and ambitious individuals like you. At DSV, performance is in our DNA. We don't just work - we aim to shape the future of logistics. This ambition fuels a dynamic environment built on collaboration with world-class team players, accountability and action. We value inclusivity, embrace different cultures and respect the dignity and rights of every individual. If you want to make an impact, be trusted by customers and grow your career in a forward-thinking company - this is the place to be. Start here. Go anywhere Visit dsv.com and follow us on LinkedIn and Facebook. open/close Print Share on Twitter Share on LinkedIn Send by email

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit ****************** Position Summary: This position is responsible for all QA activities that directly support execution of the process both within the Process Execution Team (PET) and in assigned areas outside of the PETs. These activities may include, but are not limited to, batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, and regulatory interactions. At this level the incumbent is not necessarily performing all the essential job functions of the role immediately. The incumbent may begin by specializing in one or more of these responsibilities whilst working to develop a solid knowledge of the process being supported and applicable cGMPs. Over time the incumbent will be expected to obtain the necessary training to become skilled in all major responsibilities of the role. Position Responsibilities: Maintain a high level of understanding of relevant production processes and quality systems Perform the QA review and approval of the following GMP documentation that has direct impact on the activities performed by, and facilities utilized in their corresponding areas as applicable: Change Requests Batch Records and associated documentation Product and Component Release transactions in SAP Quality Investigations (Deviations, Product Complaints) Validation Plans, Protocols and Reports Standard Operating Procedures Collaborate with and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems Execute QA processes including batch record review, product disposition, and quality issue resolution to maintain the flow of products and documents to meet site objectives Interface with applicable site support groups on projects (capital and non-capital) that impact the PET/assigned area, and proactively ensure GMP compliance during the planning, execution, and closeout phases of these projects Collaborate with and influence other PET/assigned area members to facilitate process improvements and risk assessments; benchmark internal and external QA practices to identify innovative efficient and effective practices Stay abreast of evolving regulatory compliance practices and recommend implementation strategies to site leaders Collaborate in data analysis and report creation on quality metrics and key performance indicators Hours (Night Shift): 6pm - 6:30am 2/2/3 Schedule (12-Hour Rotating) Minimum Qualifications: Experience in either the pharmaceutical industry, an operations environment, or Quality Assurance Excellent oral and written communication skills Strong ability and motivation to learn Preferred Qualifications: Bachelor's degree; master's degree in quality assurance/regulatory affairs is desirable Previous experience in a Lean, process-centric organization with emphasis on continuous improvement Multi-site / multi-functional experience The items described here are representative of those that must be met successfully to perform the essential functions of this job. Sponsorship or support for work authorization, including visas, is not available for this position. Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process. Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $60,000.00 - $90,000.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

Job Title: Quality Assurance Associate Job Title: Quality Assurance Associate 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 [Job Title] to join our team. In this role, you will be responsible for [briefly describe key responsibilities and tasks]. You will work closely with [mention teams or departments the role collaborates with] to [describe the role's contribution to the company's success. Job Purpose: Under the supervision of the Quality Assurance Supervisor, this person is responsible for performing field QA activities: in process checks in the aseptic processing area, approval for area clearance, AQL inspection for finished products, retention sampling for finished products, batch record review, final product release, review and approve operation documents and forms, and approval / rejection of in-coming raw materials, components, and final product labels. Ensure compliance of operations personnel with the company's procedures and Good Manufacturing Practices (GMPs). This position will also be responsible for identifying any deviations or non-conformances, writing deviation reports, performing root cause analysis, writing/revising standard operating procedures and forms, and tracking metrics, when required. Key Responsibilities: • Regular and predictable onsite attendance and punctuality. • Perform monitoring of Compounding in the aseptic processing area. • Perform AQL inspection for Finished products • Perform in-coming raw material, component, and labeling inspection and release • Review executed batch records to ensure compliance with approved procedures, and communicate and resolve discrepancies with manufacturing operators and supervisors. • Provide Quality support to Manufacturing personnel on the floor - providing guidance during GMP events and initiation of deviations and investigations. • Lead small scope projects, as assigned. • Prepare and/or revise SOPs to ensure compliance with regulations and current practices. Keep current with regulations and industry best practices and update SOPs to improve compliance. • Prepare all necessary reports in a timely manner to meet compliance requirements and business needs. • Participate in Process Validation activities, including protocol execution and reporting, as necessary. • Working knowledge of FDA regulations and application of GMPs. 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: Associates Degree in Science or equivalent with 2 to 5 years applicable Quality Assurance experience. • Preferred: Bachelor's Degree in Science or equivalent with 1-2 years applicable laboratory, pharmaceutical manufacturing, or related experience (QA preferred) Compensation: Base Salary: $ 65,000 to $ 75,000 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.

Urgently hiring a QA Documentation Associate in Grove City, OH. An ideal candidate will have at least 6 months of regulatory or quality documentation experience. This is a great opportunity to get your foot in the door and grow within this company! INTERESTED CANDIDATES CAN SEND UPDATED RESUMES TO MAMCDONOUGH @ACTALENTSERVICES .COM OR TEXT MARISA AT ************** TO SET UP A PHONE INTERVIEW! Job Description The Quality Assurance Records Administrator is responsible for supporting Document Control activities of the Quality Assurance department located in Grove City, OH. This position works with the Quality Assurance department to ensure compliance regarding documents and records. Responsibilities * Manage and maintain all controlled company documents. * Assist in creating and managing physical and electronic document systems. * Assist in creating and managing document identification, classification, and filing. * Conduct gap assessments with effective procedures and ensure compliance within document control. * Ensure revised documents are accessible. * Conform to company enforced specifications and document control procedures. * Ensure proper organization and security of documents (physical and electronic). * Perform administrative duties that include scanning, copying, and storing documents. * Assist in maintaining and updating the master document index. * Format and review site documentation in accordance with site procedures, as needed. * Assist in managing and organizing records for instruments and equipment per effective procedures. * Assist in managing and organizing test records for quality control and microbiology laboratories. * Create and manage logbooks for Manufacturing and Quality Control. * Undertake any other duties as required. Work Environment This individual will be sitting onsite at the Grove City facility in an office setting. Hours are 8am-5pm Monday to Friday, primarily supporting Quality Specialists. Pay and Benefits The pay range for this position is $21.00 - $21.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Grove City,OH. Application Deadline This position is anticipated to close on May 12, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

The Quality Analyst II is responsible for analyzing and interpreting complex healthcare data. This role will collaborate with cross-functional teams, providing analytical insight to inform strategy and interventions to drive improved quality performance. Essential Functions: Generate graphics that effectively describe, explore and summarize analyses for communication to appropriate parties Responsible for completing the analysis process to determine best course of action for each inquiry/problem Review reports and data for pattern identification, special cause variation identification, trend analysis, or other techniques and provide management level summaries that explain key findings Collaborate with team members on technical specifications and coding tactics Assist in quality dashboard development and reporting using Power BI and other visual data tools Gathers and understands requirements for analytic requests Perform any other job duties as assigned Education and Experience: Bachelor of Science/Arts degree in Management Information Systems (MIS), computer science or related field or equivalent work experience is required Minimum of two (2) year experience of HEDIS or similar quality healthcare performance metrics experience is required. 2 years Prior programming experience (i.e. SQL, SAS, Python or DAX) is required Health care delivery and/or payer experience is preferred Clinical experience is preferred Competencies, Knowledge and Skills: Proficient with Microsoft Office Suite Proficient in minimum one of the programming skills (i.e., SAS, SQL, or DAX) required Analytic skills for solving multi-dimensional business questions Graphic development & presentation skills Exposure to statistical concepts preferred Critical listening & thinking skills Effective verbal and written communication skills Problem Solving skills Knowledge of managed care and health care data coding Ability to work with IT teams, familiarity with MDS and data architecture Licensure and Certification: None Working Conditions: General office environment; may be required to sit or stand for extended periods of time Compensation Range: $62,700.00 - $100,400.00 CareSource takes into consideration a combination of a candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required for the role, and other external and internal data when establishing a salary level. In addition to base compensation, you may qualify for a bonus tied to company and individual performance. We are highly invested in every employee's total well-being and offer a substantial and comprehensive total rewards package. Compensation Type: Salary Competencies: - Fostering a Collaborative Workplace Culture - Cultivate Partnerships - Develop Self and Others - Drive Execution - Influence Others - Pursue Personal Excellence - Understand the Business This is not all inclusive. CareSource reserves the right to amend this job description at any time. CareSource is an Equal Opportunity Employer. We are dedicated to fostering an environment of belonging that welcomes and supports individuals of all backgrounds. #LI-GB1

Nature and Scope This position is a member of the Quality Assurance team. This position is responsible for ensuring the overall Quality in their assigned areas through the execution of site policies and procedures, programs and work instructions. Ensures all processes and products meet specifications and that products are produced in accordance with GMP requirements. This position is responsible for participating in material receipt, then coordinating sampling and inspection for components, in a sterile manufacturing facility. This position is responsible for ensuring the overall Quality of materials as assigned by Quality Management in coordination with other stakeholders such as Materials Management and Operations, etc. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Responsible for execution of procedural documentation as they pertain to various aspects of the receiving and sampling processes. Performs sampling of components. Conduct verifications and checks through accurate material inspections. Identify out of specification materials ensuring segregation and escalation, and perform any activities required within the Trackwise Events system Management of BPCS for verification and disposition of materials Maintain retain samples for all primary and secondary components and labeling Performance of DAF (Destruction Approval) process for rejected materials Use of Trackwise and Veeva for change controls, as needed Ensure errors and omissions are resolved according to Standard Operating Procedure (SOP) requirements Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, health and safety requirements. Ensure all components and raw materials are appropriately prepared for the applicable status disposition, including all relevant documentation. Support generation of logbooks and sheets/labels as required. Basic knowledge of cGMPs and supporting regulatory documents Perform room, area and equipment clearances that may be necessary for this job function. Able to perform tasks with minimal error rate. Assist other Quality Assurance Operations Associates, as needed. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. High School Diploma or GED equivalent required. Associates or Bachelor's Degree preferred. At least two (2) years of related experience (QA, Compliance, Auditing, Laboratory or Inspection, within a GMP environment) preferred. Must be able to do work independently. Experience in QA working in a cGMP manufacturing environment (preferred) Working knowledge and understanding of quality assurance principles and familiarity with QA programs Strong analytical skills, attention to detail and adherence to procedures. Intermediate skills in Microsoft Word and Excel are required. Excellent organizational, interpersonal and communication skills (written and oral) required. Ability to take feedback constructively and function in a team-oriented work environment. Ability to work overtime as needed. Physical Environment and Requirements Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision. Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly. Employee must be able to occasionally lift and/or move up to 25 pounds. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: ********************************************************** Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.