Quality Assurance Specialist jobs at PharMerica - 32 jobs

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

Nature and Scope Reporting to the, QA Operations & Quality Systems Director, the QA Release Senior Manager focuses on final release of all components, materials, and products utilized and produced at American Regent sterile manufacturing plants and laboratories. This position is also responsible for oversight of activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and their adherence to established Quality and Compliance requirements. This is a multi-disciplinary management role that will interact with all phases of production including manufacture of sterile injectables, laboratories, facilities/engineering, and materials at three different American Regent sites in the Columbus, Ohio area. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. Manage and assign QA staff in incoming, in-process, final inspection, and batch release. Includes the inspection & sampling of raw materials, finished products, and components. Is directly responsible for batch releases. Oversee GMP activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and ensuring conformance to established Quality and Compliance requirements. Ensures oversight for the successful life cycle development and commercialization of pharmaceuticals at external manufacturing partners. Act as a liaison between QA and other departments on quality issues related to release of incoming, in-process, and final products and report back to the QA Operations & Quality Systems Director. Initiation, review and approval of cGMP documentation including: procedures, policies, change controls, deviations. Develop and manage quality metrics to optimize performance, identify trends, and communicate to Senior level Management. Identify quality process improvements to increase efficiencies and performance of systems, operations and personnel. Identifies and resolves potential cGMP issues which may impact quality and reports results to Senior level Management. Consistently demonstrate QUALITY culture and behaviors and perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. Ensures all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements in the markets where product is sold. Ensures Quality Assurance goals and objectives are identified and met Act as a liaison between American Regent QA and third-parties on quality issues and report back to the QA Operations & Quality Systems Director Provide effective leadership including: individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Bachelors' degree in Life Science or equivalent course of study is required. 10 years progressive experience in QA Pharmaceutical environment required. 5-10 years management experience required. Strong working knowledge of Federal (FDA) Good Manufacturing Practice (GMP) requirements and guidelines and documentation practices. Excellent oral and written communication skills including strong technical writing skills. Strong organizational skills, planning skills and team-building. Ability to work independently and deliver timely results. Ability to lead cross functional teams, resolve conflicts and disagreements. Ability to travel between each of the Ohio facilities (in the greater Columbus area). American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: ********************************************************** Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Job 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.

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

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

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

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

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

Barberton, OH, USA Full-time ** Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies. **Job Description** The Quality Assurance Assistant assists the Quality Assurance (QA) Manager during audits and client visits. Helps maintain reference data in LIMS and performs spot audits internally at the request of the QA Manager. Performs customer service requests for Project Management staff, supplies SOP's, certification information, and method information. Works with the laboratory to maintain SOP's and other method performance documentation as directed by the QA Manager. **Essential Duties and Responsibilities:** + Perform QA data audits to ensure laboratory is in compliance with policies and procedures. + Assist in scheduling of proficiency testing samples and other QC samples. Process and report QC samples as routine samples to appropriate agencies. + Issue controlled and uncontrolled documents to enforce current policies and SOP's. + Assist QA Manager in maintaining the laboratory's reference data. + Prepare or post certification applications. + Assist in internal and external audits and client visits. + Ensure maintenance of training records for all employees. + Assist in identification of systematic problems within laboratories. + Recommend resolutions for ongoing or recurring nonconformance. + Maintain historical indices of technical records including SOPs, QC records, laboratory data, etc. + Ensure maintenance of records archives. + Assist operations personnel in writing QA SOP's. + Assist departments in generating MDL spreadsheets and calculations, reviewing MDL studies. + Answer questions on methods from laboratory personnel. + Subcontract laboratory information maintenance. + Laboratory surveillance to ensure equipment calibration. + Performs other duties as assigned. **Qualifications** **Education:** BS or BA in chemistry or related field or working towards an applicable degree. **Experience:** 2-5 years laboratory experience is preferred. **Preferred Candidate will have the following experience:** + Environmental analytical methods + Environmental regulatory requirements + Quality Assurance requirements + Computer skills + Communication skills + Organizational skills + Time management skills + Ability to prioritize + Professional working proficiency in English is a requirement, including the ability to read, write and speak in English. **Additional Information** **Position is onsite, located at our Barberton, Ohio location.** **Position Pay Range starts at $24.00- $25.00/hr** **Position Hours are M-F 8 AM- 4:00 PM** Eurofins Environment Testing (USA) provides a compensation range for informational purposes, the actual base salary may vary based upon, but not limited to, relevant experience and skill set, base salary of internal peers, business section, and geographic location. **We support your development!** Do you feel you don't match 100% of the requirements? Don't hesitate to apply anyway! Eurofins companies are committed to supporting your career development. **We embrace diversity!** Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique. **Sustainability matters to us!** We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives. We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal! **Find out more in our career page: ******************************* **Eurofins USA Environment Testing is a Disabled and Veteran Equal Employment Opportunity employer.**

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies. Job Description The Quality Assurance Assistant assists the Quality Assurance (QA) Manager during audits and client visits. Helps maintain reference data in LIMS and performs spot audits internally at the request of the QA Manager. Performs customer service requests for Project Management staff, supplies SOP's, certification information, and method information. Works with the laboratory to maintain SOP's and other method performance documentation as directed by the QA Manager. Essential Duties and Responsibilities: Perform QA data audits to ensure laboratory is in compliance with policies and procedures. Assist in scheduling of proficiency testing samples and other QC samples. Process and report QC samples as routine samples to appropriate agencies. Issue controlled and uncontrolled documents to enforce current policies and SOP's. Assist QA Manager in maintaining the laboratory's reference data. Prepare or post certification applications. Assist in internal and external audits and client visits. Ensure maintenance of training records for all employees. Assist in identification of systematic problems within laboratories. Recommend resolutions for ongoing or recurring nonconformance. Maintain historical indices of technical records including SOPs, QC records, laboratory data, etc. Ensure maintenance of records archives. Assist operations personnel in writing QA SOP's. Assist departments in generating MDL spreadsheets and calculations, reviewing MDL studies. Answer questions on methods from laboratory personnel. Subcontract laboratory information maintenance. Laboratory surveillance to ensure equipment calibration. Performs other duties as assigned. Qualifications Education: BS or BA in chemistry or related field or working towards an applicable degree. Experience: 2-5 years laboratory experience is preferred. Preferred Candidate will have the following experience: Environmental analytical methods Environmental regulatory requirements Quality Assurance requirements Computer skills Communication skills Organizational skills Time management skills Ability to prioritize Professional working proficiency in English is a requirement, including the ability to read, write and speak in English. Additional Information Position is onsite, located at our Barberton, Ohio location. Position Pay Range starts at $24.00- $25.00/hr Position Hours are M-F 8 AM- 4:00 PM Eurofins Environment Testing (USA) provides a compensation range for informational purposes, the actual base salary may vary based upon, but not limited to, relevant experience and skill set, base salary of internal peers, business section, and geographic location. We support your development! Do you feel you don't match 100% of the requirements? Don't hesitate to apply anyway! Eurofins companies are committed to supporting your career development. We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique. Sustainability matters to us! We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives. We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal! Find out more in our career page: ***************************** Eurofins USA Environment Testing is a Disabled and Veteran Equal Employment Opportunity employer.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies. Job Description The Quality Assurance Assistant assists the Quality Assurance (QA) Manager during audits and client visits. Helps maintain reference data in LIMS and performs spot audits internally at the request of the QA Manager. Performs customer service requests for Project Management staff, supplies SOP's, certification information, and method information. Works with the laboratory to maintain SOP's and other method performance documentation as directed by the QA Manager. Essential Duties and Responsibilities: * Perform QA data audits to ensure laboratory is in compliance with policies and procedures. * Assist in scheduling of proficiency testing samples and other QC samples. Process and report QC samples as routine samples to appropriate agencies. * Issue controlled and uncontrolled documents to enforce current policies and SOP's. * Assist QA Manager in maintaining the laboratory's reference data. * Prepare or post certification applications. * Assist in internal and external audits and client visits. * Ensure maintenance of training records for all employees. * Assist in identification of systematic problems within laboratories. * Recommend resolutions for ongoing or recurring nonconformance. * Maintain historical indices of technical records including SOPs, QC records, laboratory data, etc. * Ensure maintenance of records archives. * Assist operations personnel in writing QA SOP's. * Assist departments in generating MDL spreadsheets and calculations, reviewing MDL studies. * Answer questions on methods from laboratory personnel. * Subcontract laboratory information maintenance. * Laboratory surveillance to ensure equipment calibration. * Performs other duties as assigned. Qualifications Education: BS or BA in chemistry or related field or working towards an applicable degree. Experience: 2-5 years laboratory experience is preferred. Preferred Candidate will have the following experience: * Environmental analytical methods * Environmental regulatory requirements * Quality Assurance requirements * Computer skills * Communication skills * Organizational skills * Time management skills * Ability to prioritize * Professional working proficiency in English is a requirement, including the ability to read, write and speak in English. Additional Information Position is onsite, located at our Barberton, Ohio location. Position Pay Range starts at $24.00- $25.00/hr Position Hours are M-F 8 AM- 4:00 PM Eurofins Environment Testing (USA) provides a compensation range for informational purposes, the actual base salary may vary based upon, but not limited to, relevant experience and skill set, base salary of internal peers, business section, and geographic location. We support your development! Do you feel you don't match 100% of the requirements? Don't hesitate to apply anyway! Eurofins companies are committed to supporting your career development. We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique. Sustainability matters to us! We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives. We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal! Find out more in our career page: ***************************** Eurofins USA Environment Testing is a Disabled and Veteran Equal Employment Opportunity employer.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies. Job Description The Quality Assurance Manager oversees assigned laboratories to ensure compliance with company policies and procedures, implementation of a robust and effective Quality System, and employment of continuous improvement activities. This includes identifying or developing quality management tools, assessing risks and leading root cause investigations, evaluating company-wide trends for weaknesses and opportunities to advance the company's leadership position in the environmental industry, and training quality staff in the implementation of Quality Systems, techniques, and tools. Quality Assurance Manager responsibilities include, but are not limited to, the following: Ensure adherence to highest quality and efficiency standards in laboratory operations Lead team, schedule, and train employees; ensure coverage and performance; foster morale and teamwork Lead interventions in laboratories with inadequate Quality Systems or management Review assigned laboratories' monthly reports to stay current with laboratory issues and achievements Review audit responses for assigned laboratories as needed Compile Quality System metrics to monitor the status and performance of assigned laboratories Monitor laboratory certification activities to ensure no major losses of certifications Investigate issues raised by clients, QA, sales, and other departments to find root cause, implement corrective action, and document proper response Perform internal investigations of suspected data integrity related and/or ethics violation issues Provide review and comments on state, client, TNI, and federal agency programs and requirements Monitor regulatory and accreditation activities for business opportunities and threats Research Quality Systems information and stay abreast of new practices to maintain knowledge and provide guidance Participate in environmental industry committees or organizations to contribute to industry-wide initiatives that can impact the company Identify and/or develop model Quality System tools, policies, and procedures, and make these available for adoption within the laboratories Develop and participate in the Quality Management Training for new and prospective quality management staff Coordinate quality assurance and technical training courses, as applicable Assist Laboratory Directors/BUMAs in QA personnel decisions including: staffing, hiring, evaluations, and disciplinary actions as requested Attend meetings to stay current with industry trends and QA programs Participate in the Laboratory Information Management System (LIMS) oversight and standardization Assist with internal Quality Systems Audits as needed Qualifications The ideal candidate would possess the following skills and knowledge: Strong leadership, initiative, and teambuilding skills Knowledge of environmental laboratory accreditation requirements Quality Assurance and Quality Control principles Statistics and the fundamental application in an environmental laboratory Root cause analysis and corrective action principles Change management techniques and group dynamics Knowledge of environmental chemistry, regulatory methods and accreditation requirements, and instrumental techniques Experience with laboratory operations Strong analytical, logical, and negotiating skills Strong interpersonal skills and leadership abilities Ability to handle multiple priorities Strong computer, scientific, and organizational skills Excellent communication (oral and written) skills and attention to detail Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies Basic Minimum Qualifications: BS degree in a science, combination of QA experience and knowledge of the environmental testing industry may substitute for a degree. Minimum 5-10 years of environmental laboratory experience and 5 years QA experience. Advanced degree may substitute for experience. Authorization to work in the United States indefinitely without restriction or sponsorship Professional working proficiency in English is required, including the ability to read, write, and speak in English. Additional Information Position is full-time, Monday-Friday, 8 a.m.-5 p.m., with additional time as needed. Position is located at our Barberton, Ohio location. Position Pay Range is $75,000- $85,000 target range but will be reviewed based on experience. As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays, paid time off, and dental and vision options. We support your development! Do you feel you don't match 100% of the requirements? Don't hesitate to apply anyway! Eurofins companies are committed to supporting your career development. We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique. Sustainability matters to us! We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives. We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal! Find out more in our career page: ***************************** Eurofins USA Environment Testing is a Disabled and Veteran Equal Employment Opportunity employer.

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.

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.

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 * An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. * 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. 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 **************************************.

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.

Carry out QC lab analysis of raw materials, in process samples, final products, and project samples so that results are accurately determined in a timely manner, properly communicated to customers, and performed in accordance with the established Quality Systems based on ISO 9001, FSSC 22000/ISO 22002, and all applicable cGXP. This ensures that the manufacturing operation is well supported, and outside customers are promptly served with the correct product, quality, and information. As needed develop and validate analytical methods. Review data, processing records and or all other quality records for accuracy prior to release. Assist with Regulatory requests as it pertains to Quality Assurance. ESSENTIAL DUTIES AND RESPONSIBILITIES Key responsibilities include, but are not limited to the following: Carry out all work to the appropriate Quality Standards, ISO 9001, FSSC 22000/ISO 22002, cGXPs, and API, as appropriate in each laboratory. Flag any issues as they arise. Responsible for daily calibrations of all lab equipment and maintenance of records to the appropriate Quality Standards to ensure equipment is always ready for use. Work independently, as well as in a team, so that work is smoothly and efficiently handled, shift hand-over is completed with a full understanding of ongoing issues, support production operators in their in-process testing, with clear and current communication with the lab manager/supervisor of issues and how they are being handled. Recognize, investigate, and troubleshoot questionable results and equipment problems so that resolution of the matter is obtained in a timely manner, and the proper people are kept informed or asked for guidance. Analyze incoming raw materials, in process samples, finished goods, and project samples per the established SOPs using various instrumentation and techniques in the QC and API laboratories. Fully functional in API testing and API data review. Manages OOS investigations and ensures timely closure and resolution. Responsible in ensuring any CAPAs implemented were effective and monitored. Drive the implementation of new testing methods and/or method improvments. Primary trainer in laboratory testing and tasks. Follows all Company policies, procedures, and instructions using cGMP so that work is properly and safely done, the quality system is maintained, and good housekeeping is carried out. Communicates fully with internal and external customers so that their requirements and results are fully understood, and any interpretation of the information is properly supplied. Attend morning meetings with production to discuss testing status. Review and approve the daily logs reported by the QC lab. Provide technical and hands on leadership to resolve analytical issues, maintain all instruments, and help communicate data. Ensure all instruments are functional and in good working order and meeting compliance requirements. Serve as a technical resource for customer complaints and requests. Input, update, and maintain specifications across the databases and systems and work with the Technical Team. Lead special projects through completion including, but not limited to, validation work. Oversee quarterly testing and data monitoring. Evaluate current instrumentation and their performance and make recommendations on potential new technologies and/or replacements. Note: The duties listed above are not all inclusive and may be subject to periodic updating or revision. The Ideal Candidate Desired Background Bachelor's degree in chemistry, or related field of study and a minimum of 5 years of lab experience. Knowledge, Skills & Talents More specifically, we would seek the following attributes and competencies for the position: Must be able to apply good safety practice, good laboratory practice - GLP, ISO 9001. Experience in cGMP, GDP and operate to the quality regime, i.e. FSSC 22000/ISO 22002 is strongly preferred. Has demonstrated experience and competence with all instrumental analysis and wet chemistry techniques such as GC, GC MS, HPLC, TLC, Liquid Chromatography, automated titrations, physical property testing, color measurement, and spectroscopic techniques; as well as be able to teach the techniques, demonstrate good lab practice, do basic troubleshooting, and maintain good records including lab books. A good sense of smell is required for organoleptic testing. Computer skills are required as the chemists must be able to use databases, spreadsheets, word processing software, LIMS, and computer-controlled instruments. Must have excellent written and verbal communication skills. Strong organizational skills, decision-making, and record keeping skills are also required. The ability to work in a team environment as well as independently with minimal supervision is necessary with an aptness to provide adequate communication. This individual will be customer facing and may be required to communicate with customers and team members. Must have flexibility to work any other shifts and be able to work overtime as required. Is a strong and reliable trainer. Highly skilled in analytical instrument operation, troubleshooting, and maintenance. Ability to assist in research and development of methodology for new product analysis implementation. Pay and Benefits The pay rate for this position starts at $28.00/hr. Actual pay will be determined based on education, certifications, experience, qualifications, skills and geographic location. This position is eligible to participate in a short-term incentive program. Vantage offers a comprehensive benefits package to eligible employees, including: Medical, HSA, dental, vision FSA (limited purpose, dependent care, and commuter/parking) Life and AD&D insurance Accident, hospital indemnity and critical illness insurance Short- and long-term disability EAP, identity theft protection Paid time off, Parental Leave 401(k) with company match Equal Employment Opportunity Vantage is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status or any other protected category. About Vantage Vantage provides natural solutions to our customers' technical performance and marketing needs through a unique combination of chemistry, application expertise and service. Underpinned by our broad portfolio of formulations, ingredients and actives that are built on a backbone of sustainable oils, fats and their derivatives, Vantage targets selected markets and applications including personal care, food, surface treatment, agriculture, pharma, and consumer and industrial performance. Vantage is headquartered in Deerfield, IL., operates in 11 countries worldwide and employs more than 1,000 talented professionals focused on delivering exceptional customer experiences with every interaction. We are a dynamic people-centered organization where you'll be part of a collaborative global team. Embracing our cultural diversity, we learn from each other to constantly improve, adapt and iterate. We value the voices and talents of our colleagues, empowering them to drive their unique ideas to completion. We're convinced that exceptionally motivated employees produce outstanding results and we celebrate them by fostering a culture of recognition, development, learning, excellence and shared achievement. Most importantly, we know you're going to like it here. For more information visit: vantagegrp.com or LinkedIn/vantage.