Quality Assurance Coordinator jobs at PharMerica - 27 jobs

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. Additional Job Information This is a salary position Salary Range USD $21.10 / Hour

Job Title: Manager, Quality Assurance Job Type: Full-Time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Quality Assurance Manager to join our team. In this role, you will be responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that products are manufactured in compliance with cGMP guidelines, USP and FDA, EU requirements. In addition, you will be responsible to direct batch record review, control and release, handle investigation process (CAPA) assuring that any discrepancies are investigated thoroughly and in a timely manner. Key Responsibilities: Regular and predictable onsite attendance and punctuality. Directs the batch record review process. Makes final accept/reject disposition on product lots. Assures batch is manufactured in compliance with NDA/ANDA/EU, cGMP and Validation parameters. Ensures that records are reviewed and released in a timely manner. Coordinates communication for status of lots and status of and resolves issues related to accept/reject disposition of batches. Places lots on HOLD if Quality issues are detected and notifies senior management. Coordinates destruction of rejected finished goods and assures destruction occurs in a timely manner. Expedites and prioritizes product releases by coordinating the Review, testing, and releases with site management to meet customer service requirements. Conducts routine investigation and departmental meetings to facilitate the performance of release function. Manages personnel for in-process filling and inspection/packaging monitoring Provide QA oversight of Operation for the entire Manufacturing process, supporting Clean room technicians and production technicians as needed to identify and address product quality compliance issues as they arise. Provide training and assistance to all Clean room and operation personnel for NCR, CAPA and Change Control. Provides QA review and approval of manufacturing investigations assuring timely review, follow-up, tracking and trending of MIRs. Perform Root Cause analysis and assure corrective action (CAPA) implementation associated with manufacturing investigations. Provide guidance to the investigation scientists on reporting and metrics required for different levels within organization. Performs QA review and approval of LIR's (Laboratory Investigation Reports). Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR's, Commissioning Documents, FAT's), engineering documents. Establish a qualification and Requalification program for Clean Room Certification and Recertification, for ISO 5 and 7 environments. Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff. Assists the QA management in developing on department budget. Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions. Manages attendance records for all direct reports. Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: Minimum: Bachelor's degree in Pharmacy, Biology, Chemistry or a related field Preferred are beneficial [List the required qualifications such as education, skills, and experience] Preferred Qualifications: Additional college courses in Microbiology, cGMPs, Statistics or Quality Management Skills: Must have history of strong documentation skills and attention to detail Familiarity with cGMPs and CFR for US and EU Excellent organizational skills and ability to multi-task and perform work in a timely manner Demonstrates ability to lead a department, projects and meetings effectively Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management General computer skills and ability to prepare presentations and address large groups Demonstrated attention to details and accuracy The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must Compensation: Base Salary: $92,850 to $158,450 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

Nature and scope 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. 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. Achieve and maintain packaging line and inspection room clearance qualification Conduct accurate verifications and checks as well as accurate process inspections Conduct accurate packaging AQL inspections Identify out of specification product, ensuring segregation and escalation, as required 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. Conduct component and raw material release Conduct chart monitoring, ensuring escalation, as required Support product shipping activities and perform quality related oversight and verifications Generate logbooks and sheets/labels Review Bills of Materials Basic knowledge of cGMPs and supporting regulatory documents Achieve and maintain clean side gown and sterile side gown qualifications Achieve and maintain Class A qualification Perform room, area and equipment clearances. Participate in Media Fill and maintain qualification Able to perform tasks with minimal error rate. Perform any other tasks/duties as assigned by management. We all must embrace the QUALITY culture. Qualifications and Requirements High School Diploma or GED equivalent required. Associates or Bachelor's Degree preferred. Minimum 1 year work experience in a FDA regulated environment or similarly regulated area is preferred. Must be able to do work independently. 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 Physical Requirements Employee must be able to occasionally lift and/or move up to 25 pounds. 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. 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 Reporting to the QA Compliance & Change Control Sr. Manager, the QA Compliance Program Supervisor focuses on the supervision of compliance activities at American Regent. This is a multi-disciplinary management role that will interact with all phases of the product lifecycle regarding sterile injectables at all Ohio locations. 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. * 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. * Responsible for management and continual improvement of the Annual Product Review (APR) Program. * Responsible to oversee and improve the Gap Assessment Program, ensuring procedural compliance and alignment with regulatory compendia and corporate requirements. * Oversees the Compliance Corrective and Preventive Action (CAPA) System. Work with owners and cross functional teams to ensure appropriate Corrective Action plans are assigned, implemented, closed in a timely manner, and verified for effectiveness in accordance with company SOPs, and policies. * Provide day to day supervision and oversight of Quality Complaints. * Responsible for overseeing the Field Alert Program in Ohio. * Ensures procedural compliance and alignment with regulatory, compendium, and corporate requirements. * Oversees the internal audit and Inspection Readiness Programs. * Supports inspection/audit activities including 'tactical room' for all regulatory and customer audits. * Provide technical expertise and mentorship regarding the internal audit program. * Facilitate identification and resolution of objectionable cGMP issues which may impact quality and report to senior management. * Identify quality process improvements to increase efficiencies and performance of systems, operations, and personnel. * Evaluates, tracks and reports on all follow-up actions related to regulatory, corporate, or customer audits. * Continually evaluate, generate, and present Quality metrics to Senior and Executive Management. * Responsible for facilitating and supporting the Risk Management program. * 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. * Bachelor's degree in Life Science, Quality Management, or related field or equivalent experience is required. * Minimum 1 years' experience in a supervisory role required and/or has demonstrated the ability to lead, coach or mentor a team or group. * Minimum 5 years' experience in QA, Regulatory Compliance or Pharmaceutical Operations in a cGMP manufacturing environment or similar FDA regulated environment is required. * Understanding and experience in Risk Management tools and processes is required. * Proficient in the use of electronic systems (e.g. - Microsoft Office, TrackWise, Veeva EDMS) and with willingness and ability to learn new systems. * Working knowledge of application of statistical methodologies - experience with Six Sigma programs is a plus. * Excellent organizational, interpersonal and communication skills (oral and written). * Ability to work cross functionally and collaboratively with all departments at American Regent. 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 Reporting to the QA Compliance & Change Control Sr. Manager, the QA Compliance Program Supervisor focuses on the supervision of compliance activities at American Regent. This is a multi-disciplinary management role that will interact with all phases of the product lifecycle regarding sterile injectables at all Ohio locations. 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. 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. Responsible for management and continual improvement of the Annual Product Review (APR) Program. Responsible to oversee and improve the Gap Assessment Program, ensuring procedural compliance and alignment with regulatory compendia and corporate requirements. Oversees the Compliance Corrective and Preventive Action (CAPA) System. Work with owners and cross functional teams to ensure appropriate Corrective Action plans are assigned, implemented, closed in a timely manner, and verified for effectiveness in accordance with company SOPs, and policies. Provide day to day supervision and oversight of Quality Complaints. Responsible for overseeing the Field Alert Program in Ohio. Ensures procedural compliance and alignment with regulatory, compendium, and corporate requirements. Oversees the internal audit and Inspection Readiness Programs. Supports inspection/audit activities including ‘tactical room' for all regulatory and customer audits. Provide technical expertise and mentorship regarding the internal audit program. Facilitate identification and resolution of objectionable cGMP issues which may impact quality and report to senior management. Identify quality process improvements to increase efficiencies and performance of systems, operations, and personnel. Evaluates, tracks and reports on all follow-up actions related to regulatory, corporate, or customer audits. Continually evaluate, generate, and present Quality metrics to Senior and Executive Management. Responsible for facilitating and supporting the Risk Management program. 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. Bachelor's degree in Life Science, Quality Management, or related field or equivalent experience is required. Minimum 1 years' experience in a supervisory role required and/or has demonstrated the ability to lead, coach or mentor a team or group. Minimum 5 years' experience in QA, Regulatory Compliance or Pharmaceutical Operations in a cGMP manufacturing environment or similar FDA regulated environment is required. Understanding and experience in Risk Management tools and processes is required. Proficient in the use of electronic systems (e.g. - Microsoft Office, TrackWise, Veeva EDMS) and with willingness and ability to learn new systems. Working knowledge of application of statistical methodologies - experience with Six Sigma programs is a plus. Excellent organizational, interpersonal and communication skills (oral and written). Ability to work cross functionally and collaboratively with all departments at American Regent. 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 **************************************.

Due to our rapid growth we need experienced industry professionals to join our Quality Assurance (QA) team. This position will support and audit global trials in a variety of therapeutic areas, maintaining organizational and regulatory standards throughout our company. This is a vital role in our Quality Assurance department, whose success relies upon on the finely tuned skills and background of our QA Auditors. Responsibilities * Act as a Quality Program Lead on clinical trials by supporting national and international regulatory standards and guidance for pharmaceuticals, biologics and medical devices. * Develop audit management plans and audit strategy with clients for ongoing clinical trials. * Coordinate and conduct internal system audits and external investigative site/vendor audits in accordance with Good Clinical Practice (GCP) guidelines; * Participate in the development of departmental standard operating procedures, work instructions, forms, and templates; * Assess validated state and security of proprietary and cloud based software. * Develop training materials and applicable interactive tests and proficiency training including company-wide regulatory training (ICH/GCP); Qualifications * Bachelor's degree in life sciences or related field; * 2-5 years of experience in a QA department in a related industry; * Experience conducting audits of vendors and investigative sites; * Experience hosting regulatory authorities and interacting with sponsor/client representatives; * Independent thinking and planning ability; * Knowledge and application of Good Clinical Practice (GCP) is required; * Medical Device and or Phase 1 experience is a plus; * Ability to travel up to 30%-40% of time; * Excellent written and verbal communication skills; * Exceptional teamwork skills; and * Ability to work 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.

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.

Nature and Scope This position is member of the Quality Assurance (QA) Batch Record Review Group. The QA Batch Record Reviewer II is responsible for providing the Quality Assurance review associated with the manufacture of safe, pure, effective and sterile pharmaceuticals in accordance with company Standard Operating Procedures (SOPs), policies and current Good Manufacturing Practices (cGMPs). The Batch Record Review group provides support to other departments as needed and is critical in maintaining product release schedules and meeting company goals. The quality review of the batch record includes the correction and approval of batch record documentation. The position requires collaborating with multiple departments regarding metrics, exception reporting and knowledge of regulatory documents and cGMPs. This position includes travel between the American Regent facilities. 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 critical review of executed batch record documentation. Enter data into applicable spreadsheets/databases. Update metric reports for trending. Work with personnel to assure that all errors and corrections are resolved according to SOP requirements. Identify quality process improvements to increase quality and efficiencies in systems, operations, and personnel. Ensure all work is performed and documented in accordance with existing Company policies and procedures, in accordance with Code of Federal Regulations, and mutually recognized agreements with international regulatory bodies as well as and health and safety requirements. Submit error free batch records for product release. Submit Change Requests as needed. Support investigations and Corrective Actions/Preventative Actions (CAPAs), including report writing. Demonstrated basic knowledge of cGMPs and supporting regulatory documents. Mentors and provides guidance for less senior QA Batch Record Review Associates. Provides guidance for plant personnel on batch record corrections. 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. Associate or bachelor's Degree preferred. A minimum of two years equivalent experience with cGMP batch record documentation is required. QA, Compliance and Auditing experience in a cGMP manufacturing environment is required. Strong attention to detail and adherence to SOPs. Intermediate skills in Microsoft Word and Excel are required. Excellent organizational, interpersonal and communication skills (written and oral) required. Demonstrable analytical thinking and problem-solving skills. Demonstrated success in managing multiple activities at the same time, producing outstanding results. Ability to meet and maintain clean gowning requirements is preferred. Ability to take feedback constructively and function in a team-oriented work environment. Ability to work overtime as needed. Physical Environment and Requirements 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 member of the Quality Assurance (QA) Batch Record Review Group. The QA Batch Record Reviewer II is responsible for providing the Quality Assurance review associated with the manufacture of safe, pure, effective and sterile pharmaceuticals in accordance with company Standard Operating Procedures (SOPs), policies and current Good Manufacturing Practices (cGMPs). The Batch Record Review group provides support to other departments as needed and is critical in maintaining product release schedules and meeting company goals. The quality review of the batch record includes the correction and approval of batch record documentation. The position requires collaborating with multiple departments regarding metrics, exception reporting and knowledge of regulatory documents and cGMPs. This position includes travel between the American Regent facilities. 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 critical review of executed batch record documentation. * Enter data into applicable spreadsheets/databases. * Update metric reports for trending. * Work with personnel to assure that all errors and corrections are resolved according to SOP requirements. * Identify quality process improvements to increase quality and efficiencies in systems, operations, and personnel. * Ensure all work is performed and documented in accordance with existing Company policies and procedures, in accordance with Code of Federal Regulations, and mutually recognized agreements with international regulatory bodies as well as and health and safety requirements. * Submit error free batch records for product release. * Submit Change Requests as needed. * Support investigations and Corrective Actions/Preventative Actions (CAPAs), including report writing. * Demonstrated basic knowledge of cGMPs and supporting regulatory documents. * Mentors and provides guidance for less senior QA Batch Record Review Associates. * Provides guidance for plant personnel on batch record corrections. * 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. Associate or bachelor's Degree preferred. * A minimum of two years equivalent experience with cGMP batch record documentation is required. * QA, Compliance and Auditing experience in a cGMP manufacturing environment is required. * Strong attention to detail and adherence to SOPs. * Intermediate skills in Microsoft Word and Excel are required. * Excellent organizational, interpersonal and communication skills (written and oral) required. * Demonstrable analytical thinking and problem-solving skills. * Demonstrated success in managing multiple activities at the same time, producing outstanding results. * Ability to meet and maintain clean gowning requirements is preferred. * Ability to take feedback constructively and function in a team-oriented work environment. * Ability to work overtime as needed. Physical Environment and Requirements * 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 **************************************.

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

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about. **Job Summary** Perform audits of basic records and reports and inspections of routine processes to assure compliance with applicable GLP regulatory requirements. ESSENTIAL DUTIES AND RESPONSIBILITIES: + Assure Charles River's compliance with applicable GLP . Communicate all identified compliance and quality risks to supervisor. + Perform data audits to assess that records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, SOPs, and protocols. + Review SOPs, protocols, reports, and other quality and regulated records for accuracy, completeness, and compliance with all applicable GLP regulations. + Maintain written and signed records of all audits and inspections as required and sign records documenting the performance of audits and inspections and reporting to management.Identify deviations from GLP regulations, protocols and SOPs. + Independently perform inspections to monitor processes, facilities, equipment, personnel, materials, methods, practices, records, and controls to assure compliance with GLP regulations.Assist in scheduling and tracking QA audits, inspections and procedures as requested. + Perform all other related duties as assigned. **Job Qualifications** + Education: Bachelor's degree (B.A./B.S.) or equivalent, preferably in a life science or related discipline. + Experience: 1-2 years experience in QA role + Certification/Licensure: None. + Other: Knowledge of Microsoft Office applications (e.g. Word, Access, Excel). Must be able to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements. Must be detail oriented and able to effectively communicate findings verbally and in writing. PHYSICAL DEMANDS: + Must regularly operate a computer and occasionally operate other office productivity machinery such as a calculator, copy machine, and computer printer. + Must regularly communicate with employees/customers; must be able to exchange accurate information. + May occasionally be required to wear protective clothing and equipment. WORK ENVIRONMENT: + General office working conditions and/or laboratory/manufacturing areas. + The noise level in the work environment ranges from low to moderate. + May occasionally be required to work in tight or confined spaces. + May occasionally be exposed to high temperatures and humidity. COMMENTS: + May require occasional domestic travel. The pay range for this position is $50-60k/year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. Must be authorized to work in the United States without a sponsor visa, now or in the future. **About Safety Assessment** Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities. **About Charles River** Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years. We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility. **Equal Employment Opportunity** Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws. It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_**********. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications. For more information, please visit *************** 231310

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.

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.

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.

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about. Job Summary Perform audits of basic records and reports and inspections of routine processes to assure compliance with applicable GLP regulatory requirements. ESSENTIAL DUTIES AND RESPONSIBILITIES: * Assure Charles River's compliance with applicable GLP . Communicate all identified compliance and quality risks to supervisor. * Perform data audits to assess that records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, SOPs, and protocols. * Review SOPs, protocols, reports, and other quality and regulated records for accuracy, completeness, and compliance with all applicable GLP regulations. * Maintain written and signed records of all audits and inspections as required and sign records documenting the performance of audits and inspections and reporting to management. Identify deviations from GLP regulations, protocols and SOPs. * Independently perform inspections to monitor processes, facilities, equipment, personnel, materials, methods, practices, records, and controls to assure compliance with GLP regulations. Assist in scheduling and tracking QA audits, inspections and procedures as requested. * Perform all other related duties as assigned. Job Qualifications * Education: Bachelor's degree (B.A./B.S.) or equivalent, preferably in a life science or related discipline. * Experience: 1-2 years experience in QA role * Certification/Licensure: None. * Other: Knowledge of Microsoft Office applications (e.g. Word, Access, Excel). Must be able to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements. Must be detail oriented and able to effectively communicate findings verbally and in writing. PHYSICAL DEMANDS: * Must regularly operate a computer and occasionally operate other office productivity machinery such as a calculator, copy machine, and computer printer. * Must regularly communicate with employees/customers; must be able to exchange accurate information. * May occasionally be required to wear protective clothing and equipment. WORK ENVIRONMENT: * General office working conditions and/or laboratory/manufacturing areas. * The noise level in the work environment ranges from low to moderate. * May occasionally be required to work in tight or confined spaces. * May occasionally be exposed to high temperatures and humidity. COMMENTS: * May require occasional domestic travel. The pay range for this position is $50-60k/year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. Must be authorized to work in the United States without a sponsor visa, now or in the future. About Safety Assessment Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities. About Charles River Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years. We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility. Equal Employment Opportunity Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws. It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_**********. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications. For more information, please visit *************** 231310

Our corporate activities are growing rapidly, and we are currently seeking an office-based intern to join our Quality Assurance (QA) team for the Summer of 2026 The Quality Assurance (QA) team focuses on ensuring the Medpace commitment to high ethical standards and compliance with regulatory and quality management system standards is maintained. Responsibilities * Assist with quality system documentation and record management; * Support audit preparation and inspection readiness activities; * Help review and organize QA data, reports and process improvements; * Participate in meetings and projects related to quality and compliance initiatives; and * Collaborate with QA staff and other departments as needed Qualifications * Pursuing a bachelor's degree in Life Sciences * Strong attention to detail and organizational skills * Proficient in Microsoft Office (Word, Excel, Outlook) 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.