American Regent jobs - 31 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 **************************************.

Nature and Scope The QC Microbiology Supervisor works with Microbiologists, Microbiology Technicians and Microbiology Assistants in the activities associated with the Microbiological testing required in support of sterile pharmaceuticals in accordance with company Standard Operating Procedures, cGMPs and all other company policies. The incumbent will act as a company associate in ensuring the Microbiology laboratory meets schedules and forecasts in a timely, efficient manner, while maintaining neat and accurate records. The Microbiology Supervisor will oversee the day-to-day functions of the Microbiological laboratory providing training, guidance, and support as required. 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. Ensure all work is performed and documented in accordance with existing company policies, procedures, and Current Good Manufacturing Practices, health, and safety requirements. Under the direction of the Microbiology Manager, supervise the Microbiology support testing team functions, Microbiologists, and technicians. Provide technical and administrative support for all activities related to Microbiological testing and documentation. Coordinates/conduct projects and special studies with the Microbiology Manager to meet department/site requirements. Schedule employees with respect to workload to improve efficiency. Conduct laboratory testing for customer complaints and internal investigations. Ensure all microbiological documentation is complete, neat, accurate and completed in timely manner. Issue and perform investigations, deviations, or event reports, CAPAs and ensure the closure in a timely manner. Train, provide technical assistance and guidance to microbiologists and technicians. Reviews, revise and prepares SOP's and/or Protocols as necessary, recommend changes, update, and initiate change controls. Ensure tracking of support testing and release the results in timely manner. Review environmental monitoring tracking and trending of data in timely manner and present report to Microbiology Manager. Perform GAP Assessment on Microbiology procedures and keep them in compliance. Ensure and maintain the inventory required for the Microbiology laboratory and order supplies. Ensure that the laboratory is clean and sanitized. 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. Bachelor's degree in microbiology, Biology, or equivalent Life Science curriculum required. Minimum of 5 years of experience working in a cGMP compliant pharmaceutical Microbiology Laboratory. Minimum 2 years of supervisory or lead experience required. Experience with Water testing, Sterility suitability & testing of the finished products and Raw Materials, Bacterial Endotoxin Suitability & testing, Container Closure Testing, filter integrity testing, Microbial Limit Testing and Microbial Enumeration testing. Experience with Analytical Instruments such as Vitek, Balances, pH Meter, autoclave, BET, Sterility Isolators, Active Air Samplers, Particle Counters, LIMS, BSC, Incubators, etc. Experience with Trackwise for Deviations, CAPAs and Veeva CR process. Ability to lead a microbiology group towards department target goals. Experience with Microbiologist I, Microbiologist II, Microbiologist III and Microbiologist Lead duties and responsibilities. Demonstrate responsibility and accountability working within in a multi-disciplinary team environment ability to mentor subordinates. Organized individual with strong attention to detail. Excellent computer skills and proficient in Microsoft office software. 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, weekends and holidays as needed. Physical Environment and Requirements Physically able to wear laboratory 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 **************************************.

The Equipment and Process Technician I works with the Inspection and Packaging Supervisor in the activities associated with the inspection and packaging of sterile pharmaceuticals in accordance with company procedures and cGMPs. The incumbent meets inspection and packaging schedules while maintaining accurate records and professional behavior within the inspection/packaging areas. The Technician will perform manual inspection and train in the automatic inspection/packaging area for setup, of automated equipment and manual inspection processes, labeling and packaging equipment duties, line clearances and assist with inspection/packaging schedule. In conjunction with the Supervisor, the Technician plays a critical role in assuring safe, effective and compliant activities are performed in the manual inspection process while maintaining production schedules. The Equipment and Process Technician I will be proficient in all activities associated with the inspection process and be able to work with minimal supervision. The Technician will receive direction, training and mentorship from the Supervisor of Inspection and Packaging. 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. • Physically performs inspection and packaging activities as defined by established operating procedures and as directed by Manager/Supervisor. • Maintains accurate and complete records. • Maintains an accurate and complete Training Record. • Ability to set-up Manual Inspection process with little to no assistance. • Physically performs inspection, packaging, changeover, cleaning and provides documentation oversight for all such activities. • Physically performs inspection reconciliation and provides documentation oversight and acknowledgement for such activities. • Ability to review executed batch records and log books prior to submitting for final Production review. • Provides accurate and complete assistance to Quality Assurance as needed. • Works in a safe and effective manner. • Identifies and reports unsafe and non-compliant conditions. • Maintains work space in a clean and orderly manner. • Perform any other tasks/duties as assigned by management. • We all must embrace the QUALITY culture. QUALIFICATIONS AND REQUIREMENTS • High School diploma or GED preferred. Some college or technical training is a plus. • Minimum 1-year work experience in inspection, packaging, quality control and/or production preferred. • Must be able to work independently, completing assigned tasks with limited supervision. • Proven mathematical skills including addition, subtraction, multiplication, division, calculation of averages and percentages. • Excellent organizational, interpersonal and communication skills (oral and written). • Ability to take feedback constructively and consider the viewpoints of others. • Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals. • Ability to work overtime as needed. PHYSICAL ENVIRONMENT AND PHYSICAL REQUIREMENTS • Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is 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. • Employee must be able to occasionally lift and/or move up to 50 pounds. • Must be able to sit for extended hours, focusing and concentrating on items being inspected. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. 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 The Facilities Supervisor position involves supervising repairs and maintenance activities to keep the facility equipment (i.e. office, security, comfort cooling, and general equipment) operational and in compliance with Good Manufacturing Practices. This position will assist the Facilities Manager in managing and directing daily tasks within the department for all Ohio sites. 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. A. Perform and Supervise Preventive Maintenance (PM) Tasks * Identify and track facility PM tasks to completion within the CMMS system. * Tracking to include identifying new needs, opening work orders, and executing them. * Follow written PM procedures, accurately complete PM paperwork, including work orders and logbooks in accordance with existing company policies, procedures, Current Good Manufacturing Practices (cGMP), and health and safety requirements. * Coordinate access to equipment, working around customers' needs. * Lead, schedule, and oversee facilities technicians during the absence of the Facility Manager. * Assign, review, and approve department work orders in BMRAM CMMS to ensure timely completion of work. * Coordinate daily priorities with the Facility Manager, Manufacturing, Quality, EHS teams, and other departments. * Strong communication and leadership skills to manage technicians, vendors, and cross-functional teams. B. Execute Repairs * Respond to customer requests and/or alarm conditions. * Assess equipment failures/breakdowns, systematically identify problems, and restore to operation. * Accurately document repair activities. C. Support Facility Operations * Assist with onboarding new hires. * Complete facility maintenance projects (painting, light carpentry, drywall, lighting, etc) * Coordinate with Site Service Providers (security, fire protection, landscaping, snow removal, pest control, etc.). * Troubleshoot issues that arise. * Assist and supervise facilities technicians. D. Contractor Support * Schedule and coordinate contractors with customers and building management. * Support contractors performing tasks within buildings. * Ensure that contractors follow company safety and cGMP standards. * Oversee technical quality of work performed. E. Lead Small Projects * Identify potential facilities projects and recommend to Facility Manager. * Coordinate necessary parts and equipment needed for the project, including creating ePRFs and CARs. * Manage small projects to completion. * Perform any other tasks/duties as assigned by management. F. Documentation and Reporting * Maintain accurate and completed repair logs and change control documentation. * Review and approve technician work orders for accuracy and GMP compliance. * Generate reports on recurring issues and trends. * Create new requisition on the PO system to generate POs and approve for payment. * Participate in deviation investigation and provide reports as required. * Support facility manager in generating reports for audits. 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. * Required * High School Diploma or GED required and a minimum of 5 years of experience in maintenance in a manufacturing or lab environment. Bachelor's degree in a technical field preferred. * 1 to 3-years of leadership experience required and/or has demonstrated the ability to lead, coach or mentor a team or group. * Basic knowledge of electrical systems and electronics. * Basic understanding of pneumatic, electrical, and mechanical control systems such as PID Controllers, smart devices, programmers/communicators, and multimeters. * Working knowledge of Microsoft Office Applications, including Microsoft Word, and Excel. * Ability to clearly understand, describe and neatly document technical issues and work performed. * Hands-on ability to isolate problems and identify root cause of issues. * Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals. * Preferred * Experience working in a Pharmaceutical or similar regulated industry. * Working understanding of cGMP, GDP, and FDA requirements as they apply to maintaining a plus. * Basic understanding of engineering principles as they apply to facility equipment. * Basic knowledge of Building Automation Systems. * Experience in troubleshooting mechanical and electrical control problems. * Working knowledge of OSHA safe work practices. * Ability to read P&IDs, electrical drawings, and blueprints. * Comfortable working in a production environment with multiple priorities. * Basic knowledge of CMMS (computerized maintenance management systems). * Flexibility to work multiple shifts and off hours during shutdown, plus some overtime. * Basic knowledge of Siemens BAS system. Physical Environment and Requirements * Employee must be able to occasionally lift and/or move up to 50 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 entry level position is a member of the Manufacturing Team. The Manufacturing Team is responsible for activities associated with the manufacture of safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs. The Manufacturing Team ensures aseptic and sanitary conditions are maintained where required, that appropriate manufacturing area, equipment and batch records are neat and accurate and that safe, effective, and professional behavior is always displayed. The Component prep, Sanitization and Sterilization Technician I will be able to participate in all aspects of the component and equipment Prep Process including the sanitization of controlled manufacturing areas and post terminal sterilization. The Component Prep Process includes dispensing components (Caps and Seals), vial washing and component sterilization in accordance with established production records in a concentrated effort to manufacture sterile pharmaceuticals. The Sanitization of controlled areas plays critical role in assuring sanitary conditions of the controlled areas to manufacture sterile pharmaceuticals is maintained. The Team Member will assist with all activities associated with the component prep, sanitization and sterilization process under the direct supervision of Senior Manufacturing Team Members. In conjunction with Production Management the Manufacturing Team provides input and assistance to other Departments as needed, playing a critical role in maintaining production schedules and meeting Company Goals. 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. Performs sanitary cleaning activities as defined by established operating procedures and as directed by Manager/Supervisor. Performs a variety of production prep activities including deboxing, staging, equipment and component sterilization and post fill sterilization. Complete production documentation including logbooks, cleaning tags, batch records, etc. per quality and cGMP requirements. Ensure strict adherence to and compliance with SOP's and protocols. Ensure all work is performed and documented in accordance with existing company policies, procedures (SOP's), Current Good Manufacturing Practices (cGMPs), and health and safety requirements. Provides feedback to supervisor and peers about cycle status, equipment condition, and other issues that would affect the production schedule or relate to continuous improvement. Cleaning of all manufacturing areas Gain the Knowledge of batch records and processes cGMP Compliance Execution of tasks and working in a clean room environment Preparation of solutions and dilutions Material handling using pallet jacks and power industrial trucks Tray Transfer De-boxing Autoclave daily and weekly test including system checks Preparation of materials, equipment, and components for autoclaving Generation of component autoclave labels using work templates Understanding load patterns and cycle parameters for steam and dry heat sterilizers Loading and unloading sterilizers Requisitioning and receiving equipment and area logbooks 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 required. One year working experience in a manufacturing production environment preferred. Ability to perform repetitive lifting, cleaning, and stacking activities. Mechanical aptitude preferred. Ability to perform basic math including addition, subtraction, multiplication, division and calculations of averages and percentages. Strong attention to detail or organization skills. Excellent interpersonal and communication skills (oral and written). Demonstrated success working in a team environment. Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals. 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. Employee must be able to occasionally lift and/or 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 responsible for all sales activities (including supporting sponsorship/tradeshow opportunities) in support of all American Regent Animal Health Department (AHD) products including Adequan Canine. Candidate must reside in covered territory states, (AL, GA, MS, SC). Preferably in the Atlanta, GA 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. Achieve sales objectives for the Company's products in the territory assigned. Call on Licensed Veterinarians to sell AHD products through personal presentations and all other appropriate means. Prepare and present an annual territory sales plan, analyzing each practice's market potential, AHD products market share, problems and opportunities, developing strategies and tactics to meet the sales objectives. Gather and record individual account market data, through daily input into the approved CRM system database, reporting daily activities. Synchronize CRM territory data daily with headquarters sales data, in order to maintain up to date account information for proper pre-call planning. Identify and interact with and support Key Opinion Leaders in assigned territory, maintaining frequent contact with division marketing department to communicate knowledge about developments in the US market, opportunities and requests from KOL's. In close collaboration with the AHD Marketing Dept., monitor competitors pricing and distribution strategies; propose and implement appropriate AHD pricing and distribution strategies. Manage territory selling expenses within approved budget. Work with all appropriate corporate departments to provide customers with a top-quality level of service. Prospect for new accounts. Qualify prospects and convert to customers. Prepare and transmit required administrative work (expense reports, activity reports, etc.) in accordance with company policies and in a timely manner. At all times, represent the AHD in a positive and professional manner and ensure that the AHD maintains the highest level of business ethics in its US operation. Foster an atmosphere of mutual respect and exhibit strong team behavior among all members of AHD and American Regent. 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 preferred or 5 + years of related experience required. Minimum 3 years successful sales experience in the pharmaceutical market or 5+ years' experience in the Animal Health segment required. Proficient in MS Windows, Word, Excel, PowerPoint and Outlook, knowledge of CRM. Excellent oral and written communication skills. Strongly self-motivated. Must have valid US Drivers License. Travel up to 70% required; Territory Manager must be flexible to attend national or regional events that could require attendance on the weekend, as needed. Candidate must reside in covered territory (AL, GA, MS, SC). Expected Salary Range: $93,500-97,000 The salary range, is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience.American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a widerange of other benefits. 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 A technical position involving instrument calibrations and operation intended to keep the facility instrumentation and equipment (i.e., process, utility, and general equipment) within compliance of cGMPs. 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 Preventative Maintenance Tasks Follow written PM procedures. Accurately complete PM paperwork, including work orders and logbooks in accordance with existing company policies, procedures, and Current Good Manufacturing Practices, health, and safety requirements. Perform PM of all types of plant equipment including coordinating access to equipment working around customer's needs. B. Execute Repairs Respond to customer requests and/or alarm conditions. Assess instrument failures/breakdowns, systematically identify problems, and restore to operation. Accurately document repair activities. Support Quality Assurance investigations of failures/breakdowns. C. Operate Plant Utilities Monitor site (steam, electric, chilled water, compressed air, etc.) and clean (WFI, clean steam, etc.) utility operating parameters. Respond to out-of-range conditions or trends. Troubleshoot issues that arise. D. Contractor Support Support contractors performing tasks within building. Ensure that contractor employees follow company safety and cGMP standards. Oversee technical quality of work performed. E. Lead Small Projects Manage small ( 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. H.S. diploma or GED required. Trade School/certification in a technical discipline preferred. Minimum 1 year of experience in maintenance in a manufacturing or lab environment preferred. Experience working in a Pharmaceutical or similar regulated industry preferred. Must be comfortable in the use of Microsoft Office Applications, including Microsoft Word, and Excel. Basic knowledge of CMMS (computerized maintenance management) systems. Basic knowledge of electrical systems and electronics. Basic understanding of pneumatic, electrical, and mechanical control systems such as PID Controllers, smart devices, programmers/communicators, and multimeters. Basic understanding of engineering principles as they apply to facility and production equipment. Basic knowledge of instrumentation field wiring and to PLCs (Loop Powered and self-powered instruments, RTDs, thermocouples, etc.). Some background in troubleshooting mechanical and electrical control problems with Allen Bradley or Siemens PLC experience. Detail oriented. Hands-on ability to isolate problems and identify root cause of issues. Ability to focus on problem at hand in systematic manner. Able to troubleshoot systems and instruments. Ability to clearly describe technical issues. Ability to clearly and neatly document work performed. Ability to follow PM procedures that clearly define required tasks. Working knowledge of OSHA safe work practices. Working understanding of cGMP, GDP, and FDA requirements as they apply to maintenance a plus. Ability to read P&ID's, electrical drawings, and blueprints. Ability to work independently with some supervision. Good organizational, interpersonal and communication skills (oral and written). Comfortable working in production environment with multiple priorities. Able to work and interconnect effectively as a team member. Able to juggle multiple tasks with supervisory guidance. Comfortable working in culture of performance that emphasizes responsiveness. Works to ensure that customer timelines are understood and met. Flexibility to work multiple shifts and off hours during shutdown plus some overtime. This position is part of a multi-shift operation and may require assignment to a regular off shift and/or weekends schedule. 9TMust be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals. 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. Employee must be able to occasionally lift and/or move up to 50 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 **************************************.

At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit *************************************** Follow Allergan Aesthetics on LinkedIn. Allergan Aesthetics | An AbbVie Company Job Description As the Manager, Agile Practices, you will report to the Senior Manager, Tech Business Operations & Agile Practices as well as continuously collaborate with key stakeholders across the business to solve the most important technical problems. Employees can work remotely You Will: · Manage, mentor, and grow a team of Agile Specialists, providing hands on support, regular feedback, and career development. · Establish clear performance expectations, foster a culture of accountability, and drive continuous improvement. · Ensure consistent implementation of Agile Practices while identifying and implementing continuous improvement of those practices. · Drive agile maturity by establishing standards of work, metrics-driven insights, and cross team collaboration. · Oversee and continuously improve planning processes to provide visibility into multiple quarters of work ahead while ensuring clarity of scope, dependencies, and key milestones. · Standardize reporting practices for KPIs such as velocity, burndown, and other delivery metrics, consolidating and presenting this data transparently to inform leadership of progress and enable decision making. · Track progress, identify and manage risks, and remove obstacles across Engineering teams supported by Agile Specialists. · Build strong partnerships to collaborate across the business, with key partners such as Product, Engineering, Program, Design, and business stakeholders, ensuring shared context, coordinated execution, and predictable outcomes. · Oversee the effective use of Jira and other tooling used by Agile Specialists, ensuring data integrity, consistency, and scalability across teams. Qualifications Bachelor's degree in Business, Information Technology, or related field. 6+ years' experience in Agile delivery, with at least 2+ years of direct people management experience. Expertise in Agile frameworks (Scrum, Kanban, SAFe or similar) with a proven track record of scaling agile practices across teams. Strong leadership and coaching skills. Strong problem-solving skills and adaptability. Excellent organizational, communication, and interpersonal skills, with the ability to manage through ambiguity and change. Strong stakeholder management skills and the ability to influence at multiple levels of the organization. Data-driven mindset with the ability to leverage metrics to drive accountability and improvement. Ability to work collaboratively with cross-functional teams. Proficiency in JIRA, Confluence, and related tooling. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. This job is eligible to participate in our long-term incentive programs Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: *************************************************************

Nature and Scope The Pharmacovigilance (PV) Manager, Aggregate & Trend Reports position will lead aggregate, trend, and signal detection reporting (Periodic Reporting) for human products. The position will also lead the Periodic Reporting for veterinary products and support Veterinary Medicine by providing data for trending/signaling activities and additional ad-hoc activities as requested.Key, cumulative, or aggregate, reporting for the safety assessment of drugs will be assessed, reviewed with key stakeholders, and reported to key regulatory agencies.This position will compile aggregate safety reports and trending/signaling activities under the direction of the Medical Director, Pharmacovigilance for human products. Separate from individual case safety reporting, the periodic reports provide an important role in risk-benefit evaluation of each drug product and involve collective analysis of cases in the database, monitoring regulatory actions, and literature searches to provide a broader view of the safety profile of each human and veterinary drug product. 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. Generate PV trending data relating to both human and veterinary products. Complete routine queries of the Argus, Argus Insight, RxLogix and PV Works databases at American Regent, Inc. Lead work with cross-functional teams in improving processes, and support safety database upgrades, within aggregate reporting and safety analyses. Prepare PV data for Quarterly and Annual Periodic Adverse Drug Experience Reports (PADERs) and aggregate safety reports following regulatory guidelines and SOPs. Act as the RxLogix system business owner oversees setup, user access, coordinate with vendor any maintenance, upgrades and issue resolutions for PV Signal Detection. Prepare veterinary PV data for Yearly and 6-month Periodic Drug Experience Reports following regulatory guidelines and SOPs. Under the supervision of the department head or designee, coordinate the quarterly Data Safety Review Board (DSRB) meetings, preparation, distribution and filing of DSRB meetings/ ad hoc safety meetings. agenda, ad hoc safety meetings, minutes and archive of meeting agenda and reports. Work with individuals in each division and across various departments (Regulatory, Clinical R&D, Medical Affairs, Legal, Quantitative Sciences, and Quality Affairs) interface with the Pharmacovigilance process. This individual will maintain current knowledge of standard operating procedures (SOPs) and guidance documents including Worldwide/Health regulations. Maintain and update safety surveillance watchlist on a regular basis to ensure they remain current and compliant with internal procedures and regulatory requirements. Assist in the development and maintenance of Department SOPs and procedures. 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. Masters in Life Sciences, Biology, Biotech, Microbiology Degree or RN required. PharmD or PhD a plus. Minimum of 5 years' experience in Pharmacovigilance including the preparation of PADERS and knowledge of signaling/trending analysis; strong clinical background required. Skills with safety databases (Argus, Argus Insight) is a plus. Ability to assess adverse drug reactions (ADRs) and interpret data. Knowledge of Worldwide/Health Authority regulations for pharmaceutical industry governing the reporting of adverse drug experiences/events in the post-marketing (spontaneous, literature, study) and IND environment preferred. Excellent technical/medical writing and verbal communication skills; detailed knowledge of Microsoft Word and Microsoft Excel; ability to work independently as well as in a team environment. Able to manage and accomplish multiple priorities simultaneously. Able to lead/manage projects and work efficiently with both internal/external stakeholders as assigned by the supervisor. 10% travel maybe required for team meetings and potential audits. Expected Salary Range: $135,000-150,000 The salary range, is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience.American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a widerange of other benefits. 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 The Environmental Monitoring Team is responsible for the activities associated with the manufacture of safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies, and cGMPs. The Environmental Monitoring Team works in concert with and assists the manufacturing department, and plays a critical role in ensuring environmental control of the aseptic manufacturing facility. The EMT I position is primarily responsible for performing environmental monitoring activities including water collection, air, surface and personnel monitoring within the sterile manufacturing facility. 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. Plan daily workload to meet requirements. Conduct environmental monitoring activities including air, surface and personnel inside the sterile manufacturing areas. Conduct water sampling throughout facility. Record results and report deviation from specifications. Communicate any discrepancies or deviations to supervision/management upon discovery. Ensure all work is performed and documented in accordance with existing company policies, procedures, Current Good Manufacturing Practices, and health and safety requirements. Inputs data into database and conduct trend analysis. 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 Degree in microbiology, biology or related scientific field preferred. Academic or industry work experience in laboratory setting or manufacturing with focus on microbiology preferred. Knowledge of aseptic technique preferred. Must be able to maintain Class 100 Certification for EM support. Ability to work independently with minimal supervision. Organization and attention to detail. Excellent communication skills (Oral and Written). Working knowledge of MS-Office software and PC Skills Required. Good work ethic and highly motivated. Ability to work in a fast paced environment. Ability to work in a team oriented environment. Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals. 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. Job activities require long periods of standing and use of controlled movements as well as aseptic techniques/behaviors in the sterile filling suites. 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 **************************************.

At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit *************************************** Follow Allergan Aesthetics on LinkedIn. Allergan Aesthetics | An AbbVie Company Job Description As the Sr. Technical Program Manager, you will report to the Associate Director of Program Management , as well as continuously collaborate with key stakeholders across the business to solve the most important technical problems. You Will: Lead and manage complex technical programs from inception through execution. Collaborate with cross-functional teams to defi ne program objectives, deliverables, and timelines. Ensure technical feasibility and drive the implementation of new technologies. Identify and mitigate potential risks and issues to ensure timely program delivery. Qualifications Required Experience & Skills Bachelor's Degree required 5+ years experience as a Technical Program Manager or equivalent experience. Excellent written & verbal communication, building relationships across the organization, bridging gaps and cross pollinating programs. Excellent attention to detail and understanding of impact when changes occur to scope or timeline. Experience with Agile methodologies and project management tools. Strong technical background with the ability to understand and communicate complex technical concepts. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. This job is eligible to participate in our long-term incentive programs Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: *************************************************************

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 Manufacturing Team. The Manufacturing Team is responsible for activities associated with the manufacture of safe, effective and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs. The Manufacturing Team ensure aseptic and sanitary conditions are maintained where required, that appropriate manufacturing area and equipment records are neat and accurate and that safe, effective and professional behavior is displayed at all times. In conjunction with Production Management the Manufacturing Team provides input and assistance to other Departments as needed, playing a critical role in maintaining production schedules and meeting Company goals. The Team Member will be able to participate in all aspects of the Manufacturing Process. The Manufacturing Process includes loading of glass vials, stoppers, caps and seals into manufacturing machinery, unloading of finished product from the manufacturing machinery and the set-up/tear-down and line clearances of the manufacturing equipment. The manufacturing technology utilized at PharmaForce Inc. - New Albany includes HMI-PLC/SCADA controlled Isolation Barrier Aseptic Filling, Autoclave Sterilization, VHP Sterilization, CIP Sanitization, SIP Sterilization and Lyophilization. The Team Member will be proficient in all activities associated with the manufacturing process and be able to work with minimal supervision. The Team Member will receive direction, training and mentorship from the Senior Filling Operators. The Team Member will, with assistance from a Senior Team Member/s, be able to troubleshoot minor equipment adjustments and repairs during setup and during operations. The Team Member will be able to select parameters requiring Senior Team Member Approval for some manufacturing technologies using the HMI-PLC/SCADA control/data systems. 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. * Gathers, stages and returns production materials in support of manufacturing activities. * Assists team members with equipment assembly, cleaning, and storage as required to support manufacturing. * Maintains cleanliness of manufacturing equipment and areas as required to support manufacturing activities. * Staffs various stations in support of container washing, filling, stoppering, and capping. Will offload finished product. * Ensure that only approved documentation and procedures are utilized. * Oversee production supply, materials and equipment gathering, staging and sampling activities required to support manufacturing. * Oversees and performs QC sampling activities required to support manufacturing. * Ability to perform minor machine diagnostics and repairs as required. * Attends all training programs as required by Company SOPs, procedures and policies. * 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 preferred. Technical degree and/or some college in a relevant field is a plus. * Minimum one year as a Filling Operator I, having performed at a satisfactory level or similar work experience in a related field preferred. * Ability to perform basic mathematical calculations. * Possesses mechanical aptitude with the ability to assemble, troubleshoot and perform minor repairs on manufacturing equipment. * Ability to take feedback constructively and function in a team oriented work environment. * Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals. * Ability to work overtime as needed. Physical Environment and Physical 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. * 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 50 pounds. * Ability to meet and maintain cleanroom gowning requirements. * Ability to meet and maintain respirator fit-testing requirements. 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 The QC Microbiology Supervisor works with Microbiologists, Microbiology Technicians and Microbiology Assistants in the activities associated with the Microbiological testing required in support of sterile pharmaceuticals in accordance with company Standard Operating Procedures, cGMPs and all other company policies. The incumbent will act as a company associate in ensuring the Microbiology laboratory meets schedules and forecasts in a timely, efficient manner, while maintaining neat and accurate records. The Microbiology Supervisor will oversee the day-to-day functions of the Microbiological laboratory providing training, guidance, and support as required. 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. * Ensure all work is performed and documented in accordance with existing company policies, procedures, and Current Good Manufacturing Practices, health, and safety requirements. * Under the direction of the Microbiology Manager, supervise the Microbiology support testing team functions, Microbiologists, and technicians. * Provide technical and administrative support for all activities related to Microbiological testing and documentation. * Coordinates/conduct projects and special studies with the Microbiology Manager to meet department/site requirements. * Schedule employees with respect to workload to improve efficiency. Conduct laboratory testing for customer complaints and internal investigations. * Ensure all microbiological documentation is complete, neat, accurate and completed in timely manner. * Issue and perform investigations, deviations, or event reports, CAPAs and ensure the closure in a timely manner. * Train, provide technical assistance and guidance to microbiologists and technicians. * Reviews, revise and prepares SOP's and/or Protocols as necessary, recommend changes, update, and initiate change controls. * Ensure tracking of support testing and release the results in timely manner. * Review environmental monitoring tracking and trending of data in timely manner and present report to Microbiology Manager. * Perform GAP Assessment on Microbiology procedures and keep them in compliance. * Ensure and maintain the inventory required for the Microbiology laboratory and order supplies. * Ensure that the laboratory is clean and sanitized. * 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. * Bachelor's degree in microbiology, Biology, or equivalent Life Science curriculum required. * Minimum of 5 years of experience working in a cGMP compliant pharmaceutical Microbiology Laboratory. * Minimum 2 years of supervisory or lead experience required. * Experience with Water testing, Sterility suitability & testing of the finished products and Raw Materials, Bacterial Endotoxin Suitability & testing, Container Closure Testing, filter integrity testing, Microbial Limit Testing and Microbial Enumeration testing. * Experience with Analytical Instruments such as Vitek, Balances, pH Meter, autoclave, BET, Sterility Isolators, Active Air Samplers, Particle Counters, LIMS, BSC, Incubators, etc. * Experience with Trackwise for Deviations, CAPAs and Veeva CR process. * Ability to lead a microbiology group towards department target goals. * Experience with Microbiologist I, Microbiologist II, Microbiologist III and Microbiologist Lead duties and responsibilities. * Demonstrate responsibility and accountability working within in a multi-disciplinary team environment ability to mentor subordinates. * Organized individual with strong attention to detail. * Excellent computer skills and proficient in Microsoft office software. * 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, weekends and holidays as needed. Physical Environment and Requirements * Physically able to wear laboratory 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 The Key Account Manager (KAM) is responsible for access to the Multisource product line with Integrated Delivery Networks (IDNs) in their region of the country and will also work closely with affiliated [hospitals]. KAMs will report directly to the Regional Managers and will play a critical role in the implementation of the sales and contracting strategy. Must reside in covered territory of NY (State), NYC( Manhattan, Queens, Brooklyn, Bronx, Staten Island), Long Island and Northern NJ. Travel required up to 60%. 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. Customer engagement and account management Develop and execute account level business plans for assigned IDNs. Input should be solicited from a variety of internal stakeholders as business plans are being developed to ensure alignment and utilization of available resources. Establish valued relationships with key stakeholders within assigned accounts - both at the IDN and the hospital level Conduct in person meetings with greater than or equal to 50% of multisource targets each quarter covering all geographies of assigned territory. Obtain, maintain or improve access for portfolio of products with assigned accounts across all lines of business. Identify contracting opportunities and executing contracts with assigned accounts after securing approval through internal process. Collect competitive intelligence and recommend changes to management as needed. Manage contract performance and price and rebates in line with policy. National and Regional Trade show attendance Business and people leadership Demonstrate ability to work cross-functionally within the [Sales, Marketing, Analytics, Customer Service and Distribution, Commercial Operations, Regulatory Affairs, Legal, Finance, and Human Resources] to ensure corporate product objectives are met. Provide market place feedback in a timely manner to corporate management on customer business trends, competitive updates, and industry issues and opportunities. Identify opportunities and address challenges while effectively collaborating with internal stakeholders within a highly matrixed environment to ensure corporate objectives are met. Perform any other tasks/duties as assigned by management. We all must embrace the QUALITY culture. 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. BA/BS required. Master's degree preferred. Minimum of 3 years of national/regional/Key account management experience required (preferably in outsides sales). Minimum 6 years of successful prior experience in the hospital-based pharmaceutical industry required. IDN account management experience required. Generic injectable experience preferred. Understanding of GPO/IDN/Hospital relationships for pull through on GPO/IDN contracts. Experience with in patient pharmacy decision maker required. Proven success in new product and line extension launches with IDNs. Contracting experience with IDNs preferred. Demonstrated ability to manage internal and external relationships. Ability to work in an autonomous work environment. Demonstrated commitment to corporate philosophy and values. Recognized ability to effectively analyze data to highlight trends to assist shaping strategy. Utilize industry knowledge and insights to bring pertinent info to various internal stakeholders. Must reside in covered territory that includes: NY (state), NYC, Long Island and Northern NJ. Travel required up to 60%. The successful candidate must exhibit strength in the following areas: Professionalism Interpersonal skills Goal attainment Flexibility Negotiation Teamwork Written and verbal communication skills Project management and time management Situational analysis, problem solving, and strategic thinking Client relationship management Manage without direct authority Business Acumen Executive presence and high level presentation skills Computer skills (Outlook, Word, Excel, PowerPoint, etc.) Expected Salary Range: $132,800-$136,000 The salary range, is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience.American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a widerange of other benefits. 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 entry level position is a member of the Manufacturing Team. The Manufacturing Team is responsible for activities associated with the manufacture of safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs. The Manufacturing Team ensures aseptic and sanitary conditions are maintained where required, that appropriate manufacturing area, equipment and batch records are neat and accurate and that safe, effective, and professional behavior is always displayed. The Component prep, Sanitization and Sterilization Technician I will be able to participate in all aspects of the component and equipment Prep Process including the sanitization of controlled manufacturing areas and post terminal sterilization. The Component Prep Process includes dispensing components (Caps and Seals), vial washing and component sterilization in accordance with established production records in a concentrated effort to manufacture sterile pharmaceuticals. The Sanitization of controlled areas plays critical role in assuring sanitary conditions of the controlled areas to manufacture sterile pharmaceuticals is maintained. The Team Member will assist with all activities associated with the component prep, sanitization and sterilization process under the direct supervision of Senior Manufacturing Team Members. In conjunction with Production Management the Manufacturing Team provides input and assistance to other Departments as needed, playing a critical role in maintaining production schedules and meeting Company Goals. 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. * Performs sanitary cleaning activities as defined by established operating procedures and as directed by Manager/Supervisor. * Performs a variety of production prep activities including deboxing, staging, equipment and component sterilization and post fill sterilization. * Complete production documentation including logbooks, cleaning tags, batch records, etc. per quality and cGMP requirements. * Ensure strict adherence to and compliance with SOP's and protocols. * Ensure all work is performed and documented in accordance with existing company policies, procedures (SOP's), Current Good Manufacturing Practices (cGMPs), and health and safety requirements. * Provides feedback to supervisor and peers about cycle status, equipment condition, and other issues that would affect the production schedule or relate to continuous improvement. * Cleaning of all manufacturing areas * Gain the Knowledge of batch records and processes * cGMP Compliance * Execution of tasks and working in a clean room environment * Preparation of solutions and dilutions * Material handling using pallet jacks and power industrial trucks * Tray Transfer * De-boxing * Autoclave daily and weekly test including system checks * Preparation of materials, equipment, and components for autoclaving * Generation of component autoclave labels using work templates * Understanding load patterns and cycle parameters for steam and dry heat sterilizers * Loading and unloading sterilizers * Requisitioning and receiving equipment and area logbooks * 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 required. * One year working experience in a manufacturing production environment preferred. * Ability to perform repetitive lifting, cleaning, and stacking activities. * Mechanical aptitude preferred. * Ability to perform basic math including addition, subtraction, multiplication, division and calculations of averages and percentages. * Strong attention to detail or organization skills. * Excellent interpersonal and communication skills (oral and written). * Demonstrated success working in a team environment. * Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals. * 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. Employee must be able to occasionally lift and/or 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 The Facilities Supervisor position involves supervising repairs and maintenance activities to keep the facility equipment (i.e. office, security, comfort cooling, and general equipment) operational and in compliance with Good Manufacturing Practices. This position will assist the Facilities Manager in managing and directing daily tasks within the department for all Ohio sites. 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. A. Perform and Supervise Preventive Maintenance (PM) Tasks Identify and track facility PM tasks to completion within the CMMS system. Tracking to include identifying new needs, opening work orders, and executing them. Follow written PM procedures, accurately complete PM paperwork, including work orders and logbooks in accordance with existing company policies, procedures, Current Good Manufacturing Practices (cGMP), and health and safety requirements. Coordinate access to equipment, working around customers' needs. Lead, schedule, and oversee facilities technicians during the absence of the Facility Manager. Assign, review, and approve department work orders in BMRAM CMMS to ensure timely completion of work. Coordinate daily priorities with the Facility Manager, Manufacturing, Quality, EHS teams, and other departments. Strong communication and leadership skills to manage technicians, vendors, and cross-functional teams. B. Execute Repairs Respond to customer requests and/or alarm conditions. Assess equipment failures/breakdowns, systematically identify problems, and restore to operation. Accurately document repair activities. C. Support Facility Operations Assist with onboarding new hires. Complete facility maintenance projects (painting, light carpentry, drywall, lighting, etc) Coordinate with Site Service Providers (security, fire protection, landscaping, snow removal, pest control, etc.). Troubleshoot issues that arise. Assist and supervise facilities technicians. D. Contractor Support Schedule and coordinate contractors with customers and building management. Support contractors performing tasks within buildings. Ensure that contractors follow company safety and cGMP standards. Oversee technical quality of work performed. E. Lead Small Projects Identify potential facilities projects and recommend to Facility Manager. Coordinate necessary parts and equipment needed for the project, including creating ePRFs and CARs. Manage small projects to completion. Perform any other tasks/duties as assigned by management. F. Documentation and Reporting Maintain accurate and completed repair logs and change control documentation. Review and approve technician work orders for accuracy and GMP compliance. Generate reports on recurring issues and trends. Create new requisition on the PO system to generate POs and approve for payment. Participate in deviation investigation and provide reports as required. Support facility manager in generating reports for audits. 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. Required High School Diploma or GED required and a minimum of 5 years of experience in maintenance in a manufacturing or lab environment. Bachelor's degree in a technical field preferred. 1 to 3-years of leadership experience required and/or has demonstrated the ability to lead, coach or mentor a team or group. Basic knowledge of electrical systems and electronics. Basic understanding of pneumatic, electrical, and mechanical control systems such as PID Controllers, smart devices, programmers/communicators, and multimeters. Working knowledge of Microsoft Office Applications, including Microsoft Word, and Excel. Ability to clearly understand, describe and neatly document technical issues and work performed. Hands-on ability to isolate problems and identify root cause of issues. Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals. Preferred Experience working in a Pharmaceutical or similar regulated industry. Working understanding of cGMP, GDP, and FDA requirements as they apply to maintaining a plus. Basic understanding of engineering principles as they apply to facility equipment. Basic knowledge of Building Automation Systems. Experience in troubleshooting mechanical and electrical control problems. Working knowledge of OSHA safe work practices. Ability to read P&IDs, electrical drawings, and blueprints. Comfortable working in a production environment with multiple priorities. Basic knowledge of CMMS (computerized maintenance management systems). Flexibility to work multiple shifts and off hours during shutdown, plus some overtime. Basic knowledge of Siemens BAS system. Physical Environment and Requirements Employee must be able to occasionally lift and/or move up to 50 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 The Environmental Monitoring Team is responsible for the activities associated with the manufacture of safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies, and cGMPs. The Environmental Monitoring Team works in concert with and assists the manufacturing department, and plays a critical role in ensuring environmental control of the aseptic manufacturing facility. The EMT I position is primarily responsible for performing environmental monitoring activities including water collection, air, surface and personnel monitoring within the sterile manufacturing facility. 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. * Plan daily workload to meet requirements. * Conduct environmental monitoring activities including air, surface and personnel inside the sterile manufacturing areas. * Conduct water sampling throughout facility. * Record results and report deviation from specifications. * Communicate any discrepancies or deviations to supervision/management upon discovery. * Ensure all work is performed and documented in accordance with existing company policies, procedures, Current Good Manufacturing Practices, and health and safety requirements. * Inputs data into database and conduct trend analysis. * 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 Degree in microbiology, biology or related scientific field preferred. * Academic or industry work experience in laboratory setting or manufacturing with focus on microbiology preferred. * Knowledge of aseptic technique preferred. * Must be able to maintain Class 100 Certification for EM support. * Ability to work independently with minimal supervision. * Organization and attention to detail. * Excellent communication skills (Oral and Written). * Working knowledge of MS-Office software and PC Skills Required. * Good work ethic and highly motivated. * Ability to work in a fast paced environment. * Ability to work in a team oriented environment. * Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals. * 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. * Job activities require long periods of standing and use of controlled movements as well as aseptic techniques/behaviors in the sterile filling suites. 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 **************************************.