Jobs at American Regent, Inc.

Leads analytical, microbiology, sterility, environmental monitoring, and laboratory operations supporting sterile pharmaceutical manufacturing and R&D across multiple facilities. Manages testing programs, validation and qualification activities, regulatory and customer audits, laboratory personnel, equipment, investigations, CAPAs, outsourced testing, and compliance with cGMP, GLP, and regulatory requirements. Partners with manufacturing, engineering, regulatory, and quality teams to implement new technologies and improve processes.

Provides real-time quality assurance oversight in pharmaceutical manufacturing and warehouse operations. Responsibilities include batch record review, line clearance, aseptic processing audits, GMP observations, material release, deviation approval, technical document review, and support for CAPAs, investigations, calibration, maintenance, and quality systems. Requires an advanced understanding of pharmaceutical manufacturing, laboratory operations, GMPs, regulatory requirements, and controlled-room procedures.

Facilitates pharmaceutical quality compliance programs across sterile injectable production, laboratories, facilities, engineering, and materials. Responsibilities include managing internal audits, CAPA, customer complaints, gap assessments, inspection readiness, quality metrics, and continuous improvement activities. The role requires applying cGMP and U.S. regulatory requirements, supporting batch release and validation activities, and collaborating cross-functionally across Ohio sites.

Provides high-level administrative and operational support to multiple executives by managing complex calendars, communications, meetings, travel, expense reports, presentations, action items, and departmental activities. Coordinates internal and external stakeholders, events, logistics, and follow-ups while handling confidential information with discretion. Requires strong organization, communication, judgment, and independent decision-making skills in a fast-paced office environment.

Supervises training personnel and oversees operational training, on-the-job training, workforce qualification, and documentation controls in a regulated environment. Ensures employees are trained and qualified for work, tracks workforce readiness, supports audits, deviations, CAPAs, and quality events, and monitors training effectiveness and qualification trends. Develops training materials, coaches staff, and partners cross-functionally to maintain compliance, safety, inspection readiness, and operational performance.

Performs pharmaceutical microbiology quality control testing on raw materials, in-process materials, finished products, and cleanroom environments. Conducts bioburden, endotoxin, environmental monitoring, microbial enumeration, and water testing. Supports microbiological method development, validation, aseptic process simulations, sterilization activities, and container closure studies. Prepares protocols, reviews data, writes reports, and maintains SOPs and test methods in compliance with FDA, cGMP, and cGLP requirements.

Performs quality assurance activities in a regulated pharmaceutical manufacturing environment, including packaging and inspection-room clearances, process and AQL inspections, material release, chart monitoring, product segregation, documentation review, and shipping oversight. Ensures compliance with SOPs, cGMP, health and safety requirements, and product specifications. Maintains cleanroom, gowning, Class A, respirator, and media-fill qualifications while supporting quality records and resolving errors or deviations.

Performs quality assurance inspections, verifications, clearances, component and raw material releases, and packaging AQL inspections in a GMP-regulated pharmaceutical environment. Identifies and escalates out-of-specification products, reviews bills of materials, monitors charts, supports shipping oversight, maintains cleanroom and Class A qualifications, participates in media fills, and ensures accurate documentation under SOP, cGMP, health, and safety requirements.

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.

Performs autonomous QA technical reviews and audits of cGMP documentation, validation activities, analytical data, equipment records, and quality systems. Identifies and manages quality risks, supports regulatory inspections and audits, writes SOPs, conducts investigations and CAPAs, and guides personnel in resolving documentation and compliance issues. Collaborates with Validation, Engineering, Production, R&D, Operations, and Quality Systems teams across multiple central Ohio locations.

Performs pharmaceutical compounding and formulation support activities under cGMP and approved SOPs. Duties include weighing residual bulk, cleaning and preparing tanks, lines, filters, and work areas, calibrating scales and pH meters, sampling water systems, maintaining batch records and data integrity, and supporting product quality and safety. Coordinates with manufacturing, maintenance, validation, filling, microbiology, and quality control teams. Requires frequent lifting, prolonged standing, chemical handling, respirator use, and overtime availability.

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.

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.

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.

Provide real-time QA oversight of aseptic manufacturing (APA) via in‑person and video monitoring to ensure cGMP compliance. Identify, categorize, document, and escalate observations, support investigations/CAPAs, assist trending and training, review deviations, and collaborate with cross-functional teams to drive quality improvements and maintain gown qualification and aseptic behaviors.

Lead QA oversight for aseptic processing areas, including sterility assurance and video monitoring staff. Manage media fills, environmental and personnel monitoring, airflow visualization, risk assessments, deviations/CAPAs, change control, and cGMP compliance. Provide training, competency qualification, quality metrics, cross-functional collaboration, regulatory inspection support, and people management for aseptic manufacturing quality.

Responsible for managing the change control lifecycle for pharmaceutical manufacturing changes, ensuring cGMP and SOP compliance. Reviews and approves change controls, coordinates with stakeholders, supports EDMS users, prepares metrics and product reviews, develops SOPs and training, and provides inspection and post-implementation support.

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.