Quality Assurance Coordinator jobs at PharMerica

Nature and Scope Reporting to the, QA Operations & Quality Systems Director, the QA Release Senior Manager focuses on final release of all components, materials, and products utilized and produced at American Regent sterile manufacturing plants and laboratories. This position is also responsible for oversight of activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and their adherence to established Quality and Compliance requirements. This is a multi-disciplinary management role that will interact with all phases of production including manufacture of sterile injectables, laboratories, facilities/engineering, and materials at three different American Regent sites in the Columbus, Ohio area. 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. * Perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. * Manage and assign QA staff in incoming, in-process, final inspection, and batch release. Includes the inspection & sampling of raw materials, finished products, and components. Is directly responsible for batch releases. * Oversee GMP activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and ensuring conformance to established Quality and Compliance requirements. * Ensures oversight for the successful life cycle development and commercialization of pharmaceuticals at external manufacturing partners. * Act as a liaison between QA and other departments on quality issues related to release of incoming, in-process, and final products and report back to the QA Operations & Quality Systems Director. * Initiation, review and approval of cGMP documentation including: procedures, policies, change controls, deviations. * Develop and manage quality metrics to optimize performance, identify trends, and communicate to Senior level Management. * Identify quality process improvements to increase efficiencies and performance of systems, operations and personnel. * Identifies and resolves potential cGMP issues which may impact quality and reports results to Senior level Management. * Consistently demonstrate QUALITY culture and behaviors and perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. * Ensures all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements in the markets where product is sold. * Ensures Quality Assurance goals and objectives are identified and met * Act as a liaison between American Regent QA and third-parties on quality issues and report back to the QA Operations & Quality Systems Director * Provide effective leadership including: individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area. * 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. * Bachelors' degree in Life Science or equivalent course of study is required. * 10 years progressive experience in QA Pharmaceutical environment required. * 5-10 years management experience required. * Strong working knowledge of Federal (FDA) Good Manufacturing Practice (GMP) requirements and guidelines and documentation practices. * Excellent oral and written communication skills including strong technical writing skills. * Strong organizational skills, planning skills and team-building. * Ability to work independently and deliver timely results. * Ability to lead cross functional teams, resolve conflicts and disagreements. * Ability to travel between each of the Ohio facilities (in the greater Columbus area). 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 **************************************.

Job Description STAQ is currently hiring for a Quality Assurance Technicians to join our team for the 1st and 2nd shift Schedule: Monday to Friday 6 AM to 3:30 PM However, in the event of a production delay, the employee is expected to remain on-site to support operations until production is complete. Summary 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 supporting maintenance of the Quality System and providing support on Quality management projects. Roles and Responsibilities Print and maintain control of product labels Perform sampling and inspection of in-process and finished products Assist with investigations and develop and implement corrective and preventive actions geared toward continuous process improvements Perform evaluations to determine effectiveness of corrective actions Review GMP documents including master batch production records, room and equipment logs, etc. Support quality management system activities including document control and training program management Provide supplier related support to production and receiving inspection team Other duties and tasks, as assigned Qualifications and Education Requirements 1-3 years as a Quality Technician Pharmaceutical or Medical Device industry or biotechnology experience, preferably in support of manufacturing Associates degree in the sciences or equivalent experience preferred Preferred Skills Excellent independent judgement and interpersonal skills Strong attention to detail Excellent mathematical, written communication, and verbal communication skills Familiarity with Good Manufacturing Practices and FDA Regulations Proficient in using Microsoft Word, Excel, PowerPoint, Outlook Additional Notes This position will work closely with the Production team and report quality data to department management, as needed

Nature and Scope The QC Environmental Monitoring Supervisor works with Environmental Monitoring (EM) Technicians in the activities associated with the manufacture of sterile pharmaceuticals in accordance with company Standard Operating Procedures, cGMPs and all other company policies. The Supervisor will liaise with Production/Compounding Supervisor and Production/Filling Supervisor to ensure the necessary support required by those areas is provided. The Supervisor will oversee the environmental monitoring program and will provide training, guidance, and support to EM Technicians. The Supervisor will coordinate day-to-day activities and the scheduling of EM Technicians and provide input and assistance to other departments as needed. 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. Under the direction of the Microbiology Manager, supervise the environmental monitoring program and technicians. Responsible for completing and maintaining gown qualification and gown training other staff members (Hilliard). Provide technical and administrative support for all activities related to environmental monitoring, and documentation. Coordinates work projects with the Microbiology Manager to appropriately schedule EM workload to meet department/site requirements. Schedule employees with respect to workload to improve efficiency. As required assist EM technicians in sampling and other environmental monitoring responsibilities. Reviews SOP's as necessary, recommend changes, update and initiate change controls as needed. Review EM paperwork accuracy and completeness and submit to laboratory with plates for incubation in timely fashion. Issue and perform internal investigations, deviations or event reports and ensure the closure of such reports for nonconforming results, in a timely manner Perform and maintain environmental monitoring tracking and trending of data in timely manner and present report to Microbiology Manager. Ensure and check the media and material inventory required for the environmental monitoring program and order supplies as necessary. Closely interact with and support manufacturing and quality personnel in all aspects of environmental monitoring. Assist Manager with timely completion of quarterly and other periodic projects and reports. 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. Bachelor's Degree in microbiology, biology or Environmental Sciences or related scientific field preferred. 2 -3 years experience in a pharmaceutical aseptic processing environment, production QA, aseptic testing, medical device or food industry in area of microbiology or a combination required. Previous experience working in environmental monitoring/sampling, writing EM protocols and EM investigations, water sampling, performing PQ of new EM and water systems, and gown qualification program required. Experience with instruments like Met One, APC, air ideal, MAS 100, MAS 100 CG, Lighthouse System, or PMS system is required. Minimum 1-2 years of lead or supervisory experience preferred. Must flexible with working hours dependable and able to work overtime as needed, according to the production schedule. Demonstrate responsibility and accountability working within in a multi-disciplinary team environment. Ability to mentor subordinates. Excellent computer skills and proficient in Microsoft Word, Excel, and Outlook. Excellent communications skills both verbal and written. Needs to be adaptable and maintain the ability to be flexible in an ever changing and challenging environment. Sense of ownership and ability to take responsibility 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 20/40 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 **************************************.

Voted a Top Cincinnati Workplace for 4 years running, Medpace is growing rapidly, and we are currently seeking a full-time, office-based Lead Software QA Engineer to join our Information Technology (IT) team. The Medpace IT department creates custom software solutions for our internal and external business users. The Software QA Engineer is responsible for the planning and execution of software testing for one or more of these web-based applications. They will work with developers and end users to understand requirements and write test plans, execute manual and automated tests, and create summary reports. The Lead engineer has additional responsibilities to lead projects, mentor other testers, and support process improvements. Responsibilities * Lead validation projects of complex software to ensure robust functionality and compliance with regulations; * Lead and mentor junior testers; * Review and analyze functional requirements specifications to provide feedback and ensure requirements are testable; * Create test plans and test cases per documented requirements; * Lead constructive peer review of test cases; * Execute functional test cases to ensure the system is robust and fit for purpose; * Report defects and work with the development team toward resolution of the defects; * Write test summary reports; * Facilitate execution of acceptance test scripts by end users; * Attend and lead regular project meetings (daily stand-ups, refinement meetings, etc.); * Work closely with developers and end users throughout the software life cycle to ensure that applications meet the needs of the users; * Assist management team in formulating and implementing process improvements, including training staff on those processes; and * Lead project initiatives set forth by management outside the context of specific applications. Qualifications * Bachelor's degree and 6+ years of experience in software testing, preferably in an agile-like environment; * Experience leading manual testing efforts for complex software applications * Experience communicating and working within cross-departmental teams consisting of software developers, department leads, and end users; * Excellent computer skills; * Excellent analytical thinking skills; * Excellent written and oral communication skills; * Experience with direct personnel supervision is a plus!; and * Experience in the regulated healthcare industry is a plus! 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.

Job Description The Quality Control Specialist is a critical member of the team, ensuring the production and distribution of high-quality, sterile pharmaceutical products in compliance with FDA regulations, cGMP guidelines, and USP standards. This role involves conducting rigorous testing, inspections, and documentation throughout the manufacturing process to verify product integrity, sterility, and accuracy. Key responsibilities include performing laboratory analyses, environmental monitoring, and equipment calibration; reviewing and maintaining quality control records; and collaborating with cross-functional teams to identify and address quality issues. The specialist must remain updated on regulatory changes and implement continuous improvement initiatives to enhance operational quality and efficiency. Duties/Responsibilities: Works effectively and efficiently in a team environment. Conduct routine and non-routine viable, non-viable and surface environmental monitoring in all classified areas of the facility, as needed Incubation and enumeration of samples related to environmental monitoring processes, as needed. Conduct morphology assessment on appropriate samples at the conclusion of the incubation term, as needed. Perform review and release of raw materials, API, and excipients. Coordinates third party sample submission. Demonstrates the ability to perform detail-oriented work with a high degree of accuracy. Conduct investigations pertaining to OOS/OOT of raw materials, in-process, and finished product results with production personnel and/or supplier. Assists with all aspects of the quality system, such as change control, investigations, CAPA, and validation systems to ensure compliance and timely completion of assigned activities. Compiling data for quarterly report review. Review and release of finished product testing results. Generation of Certificate of Analysis and Finished Good Forms for batch release. Participate in product development meetings and represent Quality Control. Assist with the development, management and improvement of quality system processes and procedures to ensure compliance with applicable laws, regulations, and company standards in support of cGMP for pharmaceutical compounding. Lead/support audits (internal and external) to ensure compliance to CGMP regulations and internal procedures. Performs other duties as assigned. Required Skills/Abilities: Excellent verbal and written communication skills. Excellent interpersonal and customer service skills. Excellent sales and customer service skills. Excellent organizational skills and attention to detail. Excellent time management skills with a proven ability to meet deadlines. Strong analytical and problem-solving skills. Strong supervisory and leadership skills. Ability to prioritize tasks and to delegate them when appropriate. Ability to function well in a high-paced and at times stressful environment. Proficient with Microsoft Office Suite or related software. Education and Experience: BS/BA in Microbiology, Chemistry, or a relevant field/or equivalent experience. 2-5 years of Quality Control experience. Experience in a cGMP environment. Previous pharmaceutical experience. Familiarity with 21 CFR Part 11/210/211. Experience with aseptic manufacturing environments. Comfortable in a fast-paced, small company environment and able to adjust workload based upon changing priorities. Physical Requirements: Demonstrates ability to walk and stand for prolonged periods of time. Demonstrates ability to sit/ stand at a desk and working on a computer. Must be able to lift up to 15 pounds at times. Timeline: We will be accepting applications on an ongoing basis until position is filled.

Lead and execute the quality assurance and food safety programs at the point of product receipt to ensure compliance with the company's specifications and regulatory standards. Oversee inspection protocols, documentation, and corrective actions. This inspector will work closely with warehouse teams, merchandising, and suppliers to uphold product integrity and safety while driving continuous improvement in seafood quality and safety. Serve as the subject matter expert in seafood QA and food safety. Demonstrate the company's core values of respect, honesty, integrity, diversity, inclusion and safety. Minimum 3+ years of experience in one of the following areas: food safety, quality assurance and inspection, replenishment buying/procurement, merchandising, store management, operations, or brand management Strong knowledge of seafood safety standards and regulatory guidelines (FDA, NOAA, HACCP) and government regulatory guidelines related to packaging and product quality/grading Demonstrated ability to coach and train others Strong analytical and problem solving skills Proficient in Microsoft Office Excellent attention to detail and organizational skills Strong oral and written communication skills Ability to work independently and make decisions in a fast-paced environment Desired Bachelor's Degree or equivalent experience in a related field Any experience as a division sales manager, store coordinator, store manager Any experience in vendor negotiations or promo planning Inspect incoming seafood products at distribution centers and retail locations to verify compliance with Kroger's quality and food safety standards Verify product compliance with Kroger's specifications and regulatory requirements (FDA, NOAA, HACCP) Perform chemical and physical analyses on seafood, including salt content, pH, TVB-N (Total Volatile Basic Nitrogen), and moisture content, using approved methods to assess product quality and shelf life. Conduct genetic species verification, sensory evaluations, and temperature checks on incoming seafood to confirm authenticity, freshness, and compliance with cold chain requirements Identify and report non-conforming products and implement corrective and preventative actions Document inspection and analytical results accurately, maintain QA records, review data for trends or deviations, and communicate findings to QA leadership and production teams Pull samples for merchandising and suppliers for quality review and prepare additional samples for mailing as needed Participate in audits, training sessions, and continuous improvement initiatives to enhance product quality and process efficiency Provide coaching and training to associates on seafood handling and food safety protocols Collaborate with merchandising and warehouse teams to resolve quality issues and enhance receiving processes, including reviewing and accurately recording product traceability information Manage and develop relationships with key suppliers in order to strategically leverage the organization to improve case-ready quality Must be able to perform the essential job functions of this position with or without reasonable accommodation

**_What Application Development & Maintenance contributes to Cardinal Health_** Information Technology oversees the effective development, delivery, and operation of computing and information services. This function anticipates, plans, and delivers Information Technology solutions and strategies that enable operations and drive business value. Application Development & Maintenance performs configuration or coding to develop, enhance and sustain the organization's software systems in a cross-functional team environment through adherence to established design control processes and good engineering practices. This job family programs and configures end user applications, systems, databases and websites to achieve the organization's internal needs and externally-facing business needs. Application Development & Maintenance partners with business leaders, investigates user needs and conducts regular assessments, maintenance and enhancements of existing applications. The SAP Software Engineer focused on Data Conversions, Data Quality, and Reporting is responsible for designing, developing, and maintaining data solutions that ensure data integrity and enable effective business intelligence. The role combines technical skills in data migration and ETL processes with an understanding of data governance and reporting tools. **_What is expected of you and others at this level_** + Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects + May contribute to the development of policies and procedures + Works on complex projects of large scope + Develops technical solutions to a wide range of difficult problems + Solutions are innovative and consistent with organization objectives + Completes work; independently receives general guidance on new projects + Work reviewed for purpose of meeting objectives + May act as a mentor to less experienced colleagues **_Responsibilities_** + Design and execute data conversion strategies for SAP implementations and upgrades, including data extraction, transformation, and loading (ETL) from legacy systems into SAP. + Utilize SAP data migration tools such as SAP Data Services, LSMW, and Migration Cockpit to perform data loads and conversions. + Develop and maintain technical specifications, data mapping documents, and transformation rules. + Collaborate with business and technical teams to gather data requirements and ensure seamless data flow across systems. + Establish and maintain data quality frameworks to ensure the accuracy, consistency, and integrity of master and transactional data in SAP. + Perform data profiling, cleansing, and validation to identify and resolve data discrepancies before and after migration. + Define and monitor data quality metrics and key performance indicators (KPIs). + Work with business data stewards to correct data quality issues and promote data governance policies and standards. + Design, develop, and implement reporting solutions, dashboards, and analytical models using SAP technologies like SAP Analytics Cloud (SAC), SAP BW/4HANA, or SAP Fiori. + Translate business needs into technical specifications for reports and ad-hoc queries. + Optimize report performance and data extraction processes for efficiency. + Provide support and training to end-users on reporting tools to enable data-driven decision-making **_Qualifications_** + Bachelor's Degree in related field preferred or equivalent work experience preferred + Proven experience in SAP Data Conversions, migrations and ETL processes. + Proficiency with SAP data tools such as SAP Data Services, SAP BW/HANA or SAP Analytics Cloud + Strong knowledge of SQL, data modelling and database concepts + Experience with SAP modules and data structures (e.g., Master Data, Financials, Supply Chain, OTC, PTP processes). + Excellent analytical, problem solving and communication skills + Ability to work both independently and collaboratively with cross-functional teams **Anticipated salary range:** $94,900 - $135,600 **Bonus eligible:** No **Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being. + Medical, dental and vision coverage + Paid time off plan + Health savings account (HSA) + 401k savings plan + Access to wages before pay day with my FlexPay + Flexible spending accounts (FSAs) + Short- and long-term disability coverage + Work-Life resources + Paid parental leave + Healthy lifestyle programs **Application window anticipated to close:** 01/20/2026 *if interested in opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity _Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._ _Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._ _To read and review this privacy notice click_ here (***************************************************************************************************************************

**The Opportunity** This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. + Reporting compliance status data to operational quality management + Collaborate with center management in the development and implementation of continuous improvement plans + Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns + Responsible for coordinating and managing training activities, policies and processes at the center level. You will report to the Assistant Manager Quality **The Role** + Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. + Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. + Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. + Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP's, CLIA/COLA and other applicable requirements. + Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. + Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used + Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. + Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. + Identifying and communicate non-conformities to CSL's SOP's. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. + Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. + Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. + Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. + Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. + Follow all Standard Operating Procedures (SOPs), company policies and procedures. + Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. + Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. + Assist Plasma center staff in completing other special projects or assignments, as requested. + Perform other job-related duties, as assigned.dd 4-6 key responsibilities of the job **Your skills and experience** **Education** High school diploma or equivalent required. Associate or Bachelor's degree in business administration or biological sciences preferred. **Experience** + Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. + Strong customer service skills + Strong critical reasoning, decision-making and problem solving skills to analyze situations + Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives + Understand Quality Systems and/or regulated training requirements **Working Conditions** (physical & mental requirements) + Occasionally required to work with the public when they are dissatisfied + 80% of the time standing and walking and 20% of the time sitting + Reach, bend, kneel and have high level of manual dexterity + See and speak with customers and observe equipment operation + Occasionally be required to lift and carry 25 lbs. + Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors The expected base pay for this position at hiring is $18.05/hour - $20.75/hour. Please note this wage range reflects what CSL expects to pay for this position at the listed location as of the time of this posting. Individual base pay for a successful candidate within this range is determined by qualifications, skill level, experience, competencies and other relevant factors. **Our Benefits** CSL offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL's 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. For more information on CSL Plasma benefits visit **************************** . **About CSL Plasma** CSL Plasma (*************************** operates one of the world's largest and most sophisticated plasma collection networks, with over 350 plasma collection centers in the U.S., Europe and China. Headquartered in Boca Raton, Florida, CSL Plasma is a subsidiary of CSL Behring (********************* , a global biotherapeutics business and a member of CSL. Plasma collected at CSL Plasma facilities is used by CSL Behring for the sole purpose of manufacturing lifesaving plasma-derived therapies for people in more than 100 countries. The parent company, CSL (********************* , headquartered in Melbourne, Australia, employs 32,000 people. **We want CSL to reflect the world around us** At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL (**************************************************** . **Do work that matters at CSL Plasma!** R-264245 CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. ************************************************

Nature and Scope Reporting to the, QA Operations & Quality Systems Director, the QA Release Senior Manager focuses on final release of all components, materials, and products utilized and produced at American Regent sterile manufacturing plants and laboratories. This position is also responsible for oversight of activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and their adherence to established Quality and Compliance requirements. This is a multi-disciplinary management role that will interact with all phases of production including manufacture of sterile injectables, laboratories, facilities/engineering, and materials at three different American Regent sites in the Columbus, Ohio area. 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. Perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. Manage and assign QA staff in incoming, in-process, final inspection, and batch release. Includes the inspection & sampling of raw materials, finished products, and components. Is directly responsible for batch releases. Oversee GMP activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and ensuring conformance to established Quality and Compliance requirements. Ensures oversight for the successful life cycle development and commercialization of pharmaceuticals at external manufacturing partners. Act as a liaison between QA and other departments on quality issues related to release of incoming, in-process, and final products and report back to the QA Operations & Quality Systems Director. Initiation, review and approval of cGMP documentation including: procedures, policies, change controls, deviations. Develop and manage quality metrics to optimize performance, identify trends, and communicate to Senior level Management. Identify quality process improvements to increase efficiencies and performance of systems, operations and personnel. Identifies and resolves potential cGMP issues which may impact quality and reports results to Senior level Management. Consistently demonstrate QUALITY culture and behaviors and perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. Ensures all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements in the markets where product is sold. Ensures Quality Assurance goals and objectives are identified and met Act as a liaison between American Regent QA and third-parties on quality issues and report back to the QA Operations & Quality Systems Director Provide effective leadership including: individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area. 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. Bachelors' degree in Life Science or equivalent course of study is required. 10 years progressive experience in QA Pharmaceutical environment required. 5-10 years management experience required. Strong working knowledge of Federal (FDA) Good Manufacturing Practice (GMP) requirements and guidelines and documentation practices. Excellent oral and written communication skills including strong technical writing skills. Strong organizational skills, planning skills and team-building. Ability to work independently and deliver timely results. Ability to lead cross functional teams, resolve conflicts and disagreements. Ability to travel between each of the Ohio facilities (in the greater Columbus area). 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 **************************************.

Our Company ResCare Community Living Conducts case file record reviews for compliance with regulations/company processes and identifies opportunities for improvement or corrective actions to ensure contractual performance expectations. Responsibilities * Conducts Site Reviews at locations as assigned and submit results. * Participate in the Pre-Survey Review process. * Review incident reporting and initiate follow up when needed. * Participate in follow up with Corrective action plans (survey, audits, etc) * Submit weekly QA reports in a timely manner to Quality Assurance Manager/Supervisor. * Present feedback to management regarding areas that need improvement. * Ensure all clients receive a return call within 24 hours of calling. * Review quality assurance standards, studies existing policies and procedures and interviews personnel and patients to evaluate effectiveness of quality assurance programs. * Implement and monitor standard operating procedures. * Other duties as assigned. Qualifications * Associates degree in Human Services, education, psychology, sociology or related field required. Bachelor's degree preferred. * Minimum two plus years related experience * Demonstrated knowledge of quality assurance procedures and federal, state and local coalition laws and mandates * Demonstrated knowledge of computers and knowledge of data management processes * Demonstrated knowledge of eligibility determination processes and filing procedures About our Line of Business ResCare Community Living, an affiliate of BrightSpring Health Services, has five decades of experience in the disability services field, providing support to individuals who need assistance with daily living due to an intellectual, developmental, or cognitive disability. We provide a comprehensive range of high-quality services, including: community living, adult host homes for adults regardless of disability, behavioral/mental health support, in-home pharmacy solutions, telecare and remote support, supported employment and training programs, and day programs. For more information, please visit ******************************* Follow us on Facebook and LinkedIn.

Ensure consistent production of safe, quality product by following corporate and government guidelines. Supervise Quality Assurance associates. Perform all jobs safely, efficiently and accurately to maintain and improve the performance of the entire plant in the areas of Safety, Quality, Reliability (SQR) and our Customer 1st strategy. Provide leadership that embodies our 7 Kroger Manufacturing High Performance Work System principles. Demonstrate the company's core values of respect, honesty, integrity, diversity, inclusion and safety. Minimum - Bachelor's Degree food science or a related field - 5+ years quality assurance lab experience - Preventative Control Qualified Individual certification - Strong analytical and critical thinking skills; able to define problems, collect data, establish facts and draw valid conclusions - Ability to apply statistical process control concepts - Ability to read, analyze and interpret scientific and technical journals, financial reports and legal documents - SQF practitioner certified Desired - Thorough working knowledge of food safety and microbiological concepts - Plant QA Assistant Manager - Provide leadership to the plant in areas of food safety and product quality - Serve as liaison for governmental inspections - Participate in corporate regulatory compliance inspections and audits - Audit plant sanitation process through environmental testing, product testing and physical inspections - Assure that Good Manufacturing Practices (GMPs) are consistently and effectively followed and ensure pest control program compliance - Support quality initiatives by participating in routine Good Manufacturing Practices (GMP) walkthroughs and participating in or leading any food safety or quality initiatives - Monitor to ensure that Hazard Analysis Critical Control Point (HACCP), Hazard Analysis & Risk-based Preventive Controls (HARPC), Sanitation Standard Operating Procedures (SSOPs), allergen programs, formulations,& finished product consistently meet specifications - Assure that Quality Assurance staff is properly trained and resourced - Ensure thorough and effective annual training of Safe Quality Foods (SQF), Good Manufacturing Practices GMPs and Food Safety Programs - Assure that record keeping is accurate and meets Kroger, SQF and government regulations - Ensure receiving procedures for incoming and outgoing ingredients are in compliance with quality and safety standards - Investigate consumer comments, collaborate with production on resulting action plans - Assist Corporate Food Technology (CFT) with product development, product audits and calculation of raw materials - Provide support to production in continuous improvement effort - Provide feedback to suppliers to improve relationships and resolve quality issues - Assist the staff management team in all Safe Quality Food policies and requirements - Accountable to the Kroger Manufacturing Food Safety and Quality Principles - Supervise and coach direct reports in the performance of their duties; complete performance reviews and provide feedback to direct reports - Must be able to perform the essential job functions of this position with or without reasonable accommodation - Must be able to work around ingredients and/or finished products known to contain food allergens

Cardinal Health Sonexus Access and Patient Support helps specialty pharmaceutical manufacturers remove barriers to care so that patients can access, afford and remain on the therapy they need for a better quality of life. Our diverse expertise in pharma, payer and hub services allows us to deliver best-in-class solutions-driving brand and patient markers of success. We're continuously integrating advanced and emerging technologies to streamline patient onboarding, qualification and adherence. Our non-commercial specialty pharmacy is centralized at our custom-designed facility outside of Dallas, Texas, empowering manufacturers to rethink the reach and impact of their products. **Together, we can get life-changing therapies to patients who need them-faster.** **Responsibilities:** + Leads the team by evaluating calls and assess application usage based on a standard set of criteria, providing constructive feedback and recognition to ensure high performance and continuous improvement. Accurately score interactions to gauge employee's quality performance based on organizational and departmental policies and requirements. + Monitor and evaluate team performance ensuring adherence to company quality standards, and compliance with industry regulations. Tracks and reports any trends from the customer experience that can be improved or celebrated. + Analyze and provide weekly & monthly trend analysis to leadership. + Provide support to leadership by participating in and hosting internal/external client calibration sessions. + Engage in and lead projects to promote quality enhancements and/or broaden services for the team. + Shows an understanding of the requirements and is capable of conducting gap assessments based on those requirements. Uphold quality standards that adhere to company, regulatory, and HIPAA policies and procedures. + Collaborates across various functions, interprets requirements, and educates and influences others regarding those requirements. Identifies training needs or potential disciplinary actions which will be reported to leadership. + Demonstrates ability to build strong customer relationships and deliver customer-centric solutions. + Optimize work processes by identifying effective and efficient methods to complete tasks, with an emphasis on continuous improvement. + Develops strategic alliances and cooperates with stakeholders to achieve mutual goals. + Demonstrates resourcefulness by adeptly securing and efficiently deploying resources. + Analyzes complex and high-quality, sometimes contradictory, information to solve problems effectively. + Holds oneself and others accountable for meeting commitments and objectives. + Exhibits situational adaptability by adjusting approach and demeanor in real time to meet the changing demands of various situations. + Creates and implements diverse communication strategies that clearly address the specific requirements of various target audiences. + Demonstrates knowledge of quality systems and methodologies. + Demonstrates an understanding of the relevant regulations, standards, and operating procedures. + Demonstrates ability to perform investigations / root cause analysis and develop corrective actions. + Demonstrates an understanding of the requirements and has the ability to perform gap assessments to those requirements. + Demonstrates an understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, CAPA and problem solving. + Works cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements. **Qualifications:** + Bilingual in SpanishCall monitoring/audit experience preferred. + Case audit experience preferred. + HS Diploma, GED or technical certification in related field or equivalent experience, preferred. + Adverse Event reporting experience strongly preferred. + Strong customer service/quality background experience. + Excellent verbal and written communication skills + Strong prioritization and leadership skills. + High regard for superior quality of service. + Ability to prioritize and manage multiple responsibilities. + Experience handling tasks where attention to detail is critical to success. + 3+ years' experience in related field, preferred. **What is expected of you and others at this level:** + Effectively applies knowledge of job and company policies and procedures to complete a variety of assignments. + In-depth knowledge in technical or specialty area + Applies advanced skills to resolve complex problems independently. + May modify process to resolve situations. + Works independently within established procedures; may receive general guidance on new assignments. + May provide general guidance or technical assistance to less experienced team members. **TRAINING AND WORK SCHEDULES:** Your new hire training will take place 8:00am-5:00pm CST, mandatory on camera attendance is required. This position is full-time (40 hours/week). Employees are required to have flexibility to work any of our shift schedules during our normal business hours of Monday-Friday, 7:00am- 7:00pm CST. **REMOTE DETAILS:** You will work remotely, full-time. It will require a dedicated, quiet, private, distraction free environment with access to high-speed internet. We will provide you with the computer, technology and equipment needed to successfully perform your job. You will be responsible for providing high-speed internet. Internet requirements include the following: Maintain a secure, high-speed, broadband internet connection (DSL, Cable, or Fiber) at the remote location. Dial-up, satellite, WIFI, Cellular connections are NOT acceptable. + Download speed of 15Mbps (megabyte per second) + Upload speed of 5Mbps (megabyte per second) + Ping Rate Maximum of 30ms (milliseconds) + Hardwired to the router + Surge protector with Network Line Protection for CAH issued equipment **Anticipated hourly range:** $17.75 per hour - $25.60 per hour **_Bonus eligible:_** No **_Benefits:_** Cardinal Health offers a wide variety of benefits and programs to support health and well-being. + Medical, dental and vision coverage + Paid time off plan + Health savings account (HSA) + 401k savings plan + Access to wages before pay day with my FlexPay + Flexible spending accounts (FSAs) + Short- and long-term disability coverage + Work-Life resources + Paid parental leave + Healthy lifestyle programs **Application window anticipated to close:** 01/06/2026 *if interested in opportunity, please submit application as soon as possible. The hourly range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity. _Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._ _Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._ _To read and review this privacy notice click_ here (***************************************************************************************************************************

The successful candidate will be responsible for facilitating the management of sponsor audits, broad range of regulatory inspections (FDA, EMA, MHRA) 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; * Manage pre-inspection activities for Medpace inspections; * Provide inspection data trends to the Quality Metrics group for executive management review; * Manage the inspection backroom during regulatory inspections to facilitate the timely delivery of requested documents; * Conduct mock interviews for subject matter experts (SMEs) during inspection preparation; * Reviewing, and analyzing regulatory inspection data issued by regulatory authorities (e.g. MHRA, EMA, FDA); * Manage training for Medpace stakeholders with respect to inspection readiness; * Conducting inspection readiness visits at selected sites (as applicable) to assess inspection risk; * Act as QA lead for inspections at Medpace; * Provide as needed support for inspections at Medpace external clients (sponsors and investigator sites); and * Maintain the memorializing of frequently asked questions repository for regulatory inspection. Qualifications * Bachelor's degree in 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; * Experience in supporting or conducting audits; * Excellent written and verbal communications skills in English; * 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; and * 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.

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 **************************************.

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 **************************************.

**_What Quality Assurance contributes to Cardinal Health_** Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented. **_Job Summary_** The Specialist, Quality Assurance executes quality programs, policies, and procedures in a particular area of specialty (such as recalls and customer complaints) in order to minimize risks and drive supply chain integrity. With basic knowledge of quality assurance concepts, the Specialist creates reports on quality metrics and trends in support of resolutions to quality issues and the development of standard operating procedures. The Specialist frequently seeks guidance from more experienced Senior Specialists or Principal Specialists and assists on more complex projects to develop advanced knowledge and technical capabilities. **_Responsibilities_** + Lead the efforts within Cardinal Health to collect substance information on products and raw materials from suppliers + Load and extract product systematic data on substances within Cardinal Health Master Data systems + Review and evaluate received questionnaire forms for completeness and applicability + Coordinate with Supplier, Sourcing, Quality, Regulatory and Manufacturing teams to obtain information necessary to complete assigned tasks + Identify and quantify risk, communicate results effectively to management + Support management of QRA policies governing product quality data + Identify quality and regulatory related issues within current processes, investigate and provide recommendations + Interact with cross-functional business partners (Customers, Operations, Sourcing, Regulatory, Manufacturing Quality, field QRA, etc.) to assist in execution of the current Medical Distribution Quality Plan. + Responsible for deployment of policies and programs to minimize risk and enable compliant business operations for Cardinal Health + Demonstrates working knowledge of applicable laws and regulatory concepts utilized to manage risk + Supports development of programs, policies and procedures using knowledge of regulatory requirements and technologies + Works to understand complex functional situations by paying attention to the details of the tasks at hand and by breaking them down into smaller pieces + Proactively develops and maintains a broad knowledge of the technical disciplines in own functional area; applies broad knowledge of trends and best practices in a manner that ensures exceptional performance and results + Uses deep subject matter/functional expertise; influence and process skills to help internal/external customers and stakeholders identify and meet their high priority needs while considering cultural and diversity implications + Encourages informed risk-taking and acts as a catalyst for innovation at Cardinal Health; generates practical, sustainable and creative options to solve problems and create business opportunities, while maximizing existing resources + Champions and leads change initiatives; identifies the best approach for implementing strategic processes; in light of culture and diversity **_Qualifications_** + Bachelor's degree preferred + 1-3 years experience preferred + Knowledge of Regulated Substances regulations such as EU MDR, REACH, RoHS, WEE, POP and California Proposition 65 preferred + Distribution Operations processes (Medical and Pharmaceutical) preferred + Excellent verbal, written, computer, SAP, and interpersonal skills required + Excellent influencing skills + Must be able to multitask and work with competing priorities **_What is expected of you and others at this level_** + Works to understand complex functional situations by paying attention to the details of the tasks at hand and by breaking them down into smaller pieces + Proactively develops and maintains broad knowledge of the technical disciplines in own functional area(s); applies broad knowledge of trends and best practices in a manner that ensures exceptional performance and results + Uses deep subject matter/functional expertise, influence and process skills to help internal/external customers and stakeholders identify and meet their high priority needs while considering cultural and diversity implications + Encourages informed risk-taking and acts as a catalyst for innovation at Cardinal Health; generates practical, sustainable and creative options to solve problems and create business opportunities, while maximizing existing resources + Champions and leads change initiatives; identifies the best approach for implementing strategic processes in light of cultural and diversity implications **Anticipated hourly range:** $26.90 per hour - $36.90 per hour **Bonus eligible:** No **Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being. + Medical, dental and vision coverage + Paid time off plan + Health savings account (HSA) + 401k savings plan + Access to wages before pay day with my FlexPay + Flexible spending accounts (FSAs) + Short- and long-term disability coverage + Work-Life resources + Paid parental leave + Healthy lifestyle programs **Application window anticipated to close:** 12/07/2025 *if interested in opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity. _Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._ _Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._ _To read and review this privacy notice click_ here (***************************************************************************************************************************

What Quality Assurance contributes to Cardinal Health Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented. Job Summary The Principal Specialist, Quality Assurance is responsible for reviewing all customer threshold activity requests for controlled substances in compliance with set standards. This job reviews inbound requests, assesses them for risk and escalates according the standard operating procedures. The Principal Specialist, Quality Assurance assists the Manager, Regulatory Management in data entry activity and documentation drafting/filing. This job ensures the consistent application of set threshold methodologies across the organization. Responsibilities Responsible for ensuring quality standards and procedures are followed at the Cardinal Health NPHS Warehouse. Authority for approval and disposition of raw materials, components, closures, APIs, and products at the Cardinal Health NPHS Warehouse. This includes review of analytical results which may support material release. Supporting and documenting investigations where required. Organizes documentation to ensure procedure timelines are met Additional responsibility may include overarching systems which support the warehouse, for example, equipment and facility (i.e., temperature management and mapping), packaging and labelling. QA site lead for SAP material management activities. Document and report quality and compliance issues to QA management as necessary. Prioritizes and ensures work is delivered in an efficient way. May assist in the material qualification of new materials May serve as a delegate or representative Performs other job duties as assigned. Qualifications 4-8 years of experience, preferred Quality and/or Operations Warehouse experience preferred Bachelor's degree in related field, or equivalent work experience, preferred What is expected of you and others at this level Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects Understands technical/release material issues and evaluates their potential impact on quality and compliance. Reports errors in a timely and appropriate manner. Takes initiative and is accountable for areas of responsibility meeting regulatory requirements including but not limited to maintaining required trainings as appropriate to position requirements. Takes actions to continually improve quality and safety in daily work. Actively participates in improving work processes to meet and exceed expectations. Identifies opportunities for improvement based on process observations, outcome measures, and feedback. Will contribute to the development of policies and procedures Works on complex projects of large scope Develops technical solutions to a wide range of difficult problems Solutions are innovative and consistent with organization objectives Completes work independently; receives general guidance on new projects Work reviewed for purpose of meeting objectives May act as a mentor to less experienced colleagues Anticipated salary range: $79,700 - $113,800 Bonus eligible: No Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being. Medical, dental and vision coverage Paid time off plan Health savings account (HSA) 401k savings plan Access to wages before pay day with my FlexPay Flexible spending accounts (FSAs) Short- and long-term disability coverage Work-Life resources Paid parental leave Healthy lifestyle programs Application window anticipated to close: 10/07/2025 *if interested in opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply. Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law. To read and review this privacy notice click here