Hilliard, Ohio, United States · On-site
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. T…
Skills: Environmental Monitoring, Aseptic Technique, Water Sampling, cGMP, Data Entry
Brea, California, United States · On-site
$23/hr–$25/hr
Nature and Scope The role of the Materials Management Associate is to support the Materials Management team with an emphasis on warehouse and inventory management. Essential Duties and Responsibilities Nothing in this jo…
Skills: Inventory Management, Warehouse Operations, FIFO Method, Order Picking, Quality Control
United States · Remote OK
American Regent, Inc. seeks a Manager of Clinical Quality Assurance (CQA) in Shirley, NY responsible for the following: Manage the CQA activities associated with the development of study-specific audit plans and oversigh…
Skills: Clinical Quality Assurance, Pharmacovigilance Auditing, Regulatory Compliance, CAPA Management, GCP
Shirley, New York, United States · On-site
$156k–$185k/yr
Nature and Scope The Senior Manager of manufacturing will be responsible for managing and leading the day-to-day operations for the commercial aseptic manufacturing of drug and device products. The position scope can inc…
Skills: Aseptic Manufacturing, cGMP Compliance, Operational Excellence, People Management, Project Management
Shirley, New York, United States · On-site
$91k–$100k/yr
Nature and Scope The primary responsibilities of the Manufacturing Quality Engineer Lead is to assure timely and accurate completion of investigations and CAPAs. This position will organize and communicate events between…
Skills: Aseptic Technique, Root Cause Analysis, CAPA Management, cGMP Compliance, Deviation Management
New Albany, Ohio, United States · On-site
Nature and Scope Working as part of a multi-disciplinary team, the Production Engineer II must possess the ability to manage multiple tasks simultaneously, manage projects and project timelines, and create project specif…
Skills: Project Management, GMP Compliance, Troubleshooting, SOP Development, Technical Documentation
Shirley, New York, United States · On-site
Nature and Scope Utilize current Good Manufacturing Practices (cGMP) in conjunction with approved departmental SOPs to produce high quality products. Essential Duties and Responsibilities Nothing in this job description …
Skills: Packaging, cGMP, SOP Compliance, Manual Dexterity, Quality Control
Hilliard, Ohio, United States · On-site
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 ac…
Skills: Aseptic Filtration, Chemical Handling, Mass/Concentration Calculations, pH Measurement, Sterile Compounding
Brea, California, United States · On-site
$33/hr–$41/hr
Nature and Scope A technical position involving equipment repairs and maintenance activities intended to keep the facility equipment (i.e., process, utility, and general equipment) within compliance of cGMPs. Essential D…
Skills: Preventative Maintenance, Calibration, PLC Troubleshooting, Electrical Systems, Pneumatic Systems
Brea, California, United States · On-site
$70k–$75k/yr
Nature and Scope The Research associate is responsible for performing analytical activities to provide support for formulation development and process development. Essential Duties and Responsibilities Nothing in this jo…
Skills: Method Development, HPLC, UPLC, UV/VIS, GC
Shirley, New York, United States · On-site
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 acc…
Skills: Aseptic Filling, GMP, cGMP, SOP Adherence, Equipment Sanitization
California, United States · Remote OK
$94k–$98k/yr
The Territory Manager position is responsible for all sales activities (including supporting sponsorship/tradeshow opportunities) in support of all American Regent Animal Health Department (AHD) companion animal products…
Skills: Sales Strategy, CRM, Account Management, Market Analysis, Presentation Skills
Hilliard, Ohio, United States · On-site
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…
Skills: Aseptic Filling, Equipment Troubleshooting, cGMP Compliance, Machine Diagnostics, Cleanroom Gowning
Hilliard, Ohio, United States · On-site
This position is a senior 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 S…
Skills: Aseptic Filling, HMI-PLC/SCADA, Lyophilization, cGMP, Equipment Troubleshooting
New Albany, Ohio, United States · On-site
Nature and Scope The Business Systems Analyst II (BSA-II) serves as a liaison between business stakeholders and information technology, translating business needs into system requirements and ensuring technology solution…
Skills: Computer System Validation, Business Systems Analysis, GxP Compliance, SDLC, Requirements Elicitation
California, United States · Remote OK
$130k–$155k/yr
The Professional Services Veterinarian position is responsible for handling all field service veterinary medical professional needs, including advertising and promotional (A&P) review, providing detailed product informat…
Skills: Veterinary Medicine, Pharmacovigilance, Public Speaking, Technical Training, Medical Review
New Albany, Ohio, United States · On-site
Nature and Scope This position is responsible for ensuring the overall Quality in their assigned areas through the execution of site policies and procedures, programs and work instructions. Ensures all processes and prod…
Skills: cGMP, Quality Assurance, AQL Inspections, Microsoft Word, Microsoft Excel
New Albany, Ohio, United States · On-site
Nature and Scope This position is responsible for ensuring the overall Quality in their assigned areas through the execution of site policies and procedures, programs and work instructions. Ensures all processes and prod…
Skills: cGMP, Quality Assurance, AQL Inspections, Process Inspections, Microsoft Word
Columbus, Ohio, United States · On-site
Nature and Scope To provide a comprehensive Quality compliance review of cGMP analytical data and results for raw materials, in-process and finished product release, stability program results and summaries, and raw data …
Skills: cGMP Compliance, Data Review, Microbiological Assays, SOP Writing, Environmental Monitoring
Hilliard, Ohio, United States · On-site
Nature and Scope The EHS Specialist is responsible for maintaining and improving current Environmental Health and Safety programs in an FDA regulated pharmaceutical manufacturing environment through implementation of ide…
Skills: EHS Management, ISO 14001, ISO 45001, OSHA Compliance, Incident Management
Hilliard, Ohio, United States • On-site
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Perform environmental monitoring activities including air, surface, personnel, and water sampling within a sterile pharmaceutical manufacturing facility. Document results, report deviations, and conduct trend analysis to ensure environmental control.
Requires a High School Diploma or GED, with an Associate Degree in a scientific field and laboratory experience preferred. Must be able to maintain Class 100 Certification and adhere to strict cleanroom gowning and safety protocols.
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.
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
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.
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: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf
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 [email protected] 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 https://careers.americanregent.com/ 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 [email protected].
American Regent, Inc, a Daiichi Sankyo Group Company, develops, manufactures, and supplies high quality sterile injectables for healthcare providers, clinics and hospitals across the United States and Canada. We have locations in New York, Ohio, and Pennsylvania and sales territories nationwide. American Regent continues to position its business for sustainable growth, with significant investments in the modernization and expansion of our U.S. manufacturing sites. These enhancements are expected to strengthen our business and represents our commitment to the ongoing success of our company and its employees. Supporting patient health is our guiding principle and our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of brand and generic specialty injectables.
Offices: 5 Ramsey Rd, Shirley, New York 11967, US · 6610 New Albany Rd E, New Albany, Ohio 43054, US · 536 Vanguard Way, Brea, California 92821, US
American Regent, Inc, a Daiichi Sankyo Group Company, develops, manufactures, and supplies high quality sterile injectables for healthcare providers, clinics and hospitals across the United States and Canada. We have locations in New York, Ohio, and Pennsylvania and sales territories nationwide. American Regent continues to position its business for sustainable growth, with significant investments in the modernization and expansion of our U.S. manufacturing sites. These enhancements are expected to strengthen our business and represents our commitment to the ongoing success of our company and its employees. Supporting patient health is our guiding principle and our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of brand and generic specialty injectables.
Offices: 5 Ramsey Rd, Shirley, New York 11967, US · 6610 New Albany Rd E, New Albany, Ohio 43054, US · 536 Vanguard Way, Brea, California 92821, US