Jobs at American Regent, Inc.

Lead site-wide quality systems and compliance for sterile injectable manufacturing. Oversee QA/QC labs, deviation/CAPA/change control, regulatory inspections, supplier and CMO quality, batch record review/release, continuous improvement, and cross-functional implementation of new technologies and processes.

Lead site quality for sterile injectable manufacturing, overseeing QA/QC, regulatory inspections, supplier and CMO quality, deviations/CAPA/change control, batch release, continuous improvement, and cross-functional quality initiatives. Manage teams, ensure cGMP compliance, and support regulatory interactions and audits.

Supervise sterile pharmaceutical manufacturing operations, oversee batch record review, train and mentor staff, maintain cleanroom and cGMP compliance, troubleshoot equipment, manage schedules and inventory, and ensure approved materials and procedures are used.

Provide Tier 1-2 desktop support for PCs, laptops and mobile devices; install/configure hardware and software; manage onboarding/offboarding and asset inventory; use ServiceNow ticketing, LDAP and Group Policy; support VPN, MFA, Office 365 and security patches; train users and follow JSOX IT policies.

Perform microbiological QC testing (bioburden, endotoxin, TOC), environmental monitoring in Grade C/D cleanrooms, assist method development/validation, generate protocols and SOPs, support aseptic process simulations and sterilization activities, coordinate third-party testing, maintain lab inventory, train new hires, and ensure cGMP/cGLP and FDA documentation compliance.

Execute compounding and formulation tasks under cGMP and SOPs: weigh and collect bulk, clean and prepare equipment and filters, calibrate scales and pH meters, sample water systems, record batch data, maintain cleanliness and safety, coordinate with related departments, and stop production for quality or safety concerns.

Lead CAPA and effectiveness check activities to ensure compliance with SOPs, cGMP, and FDA regulations. Coordinate cross-functional teams, drive aging CAPAs to closure, support audits and inspection readiness, manage CAPA metrics, support SNCRs and Quality Council, and participate in continuous improvement initiatives.

Support aseptic pharmaceutical manufacturing by developing and maintaining SOPs, troubleshooting and optimizing process/filling equipment, ensuring GMP compliance, leading equipment installation/qualification, managing projects and vendor activities, tracking KPIs, supporting maintenance and QA investigations, and training staff.

Lead manufacturing quality activities for aseptic pharmaceutical production: manage investigations and CAPAs, perform root cause analysis, write technical documents, support training and gown qualifications, ensure cGMP compliance, partner with manufacturing and cross-functional teams, and drive continuous improvement and environmental monitoring programs.

Lead day-to-day commercial aseptic manufacturing operations (compounding, sterile filling, inspection, packaging). Provide supervisory leadership, ensure GMP/regulatory compliance (FDA, OSHA, EPA, OFCCP), drive continuous improvement, manage staffing and training, oversee quality activities (CAPA, validations, change control) and meet production, safety, and financial targets.

Serve as liaison between business and IT to define, document, and validate requirements for GxP‑regulated computerized systems. Support CSV activities across system lifecycle, author validation deliverables, assess change impacts and data integrity risks, participate in audits/inspections, and partner with Quality, IT, and business stakeholders to maintain compliant, inspection‑ready systems.