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American Regent, Inc. · 6 hours ago

Inspection and Packaging Document Control Coordinator I

New Albany, OH

Full-time

Onsite

New Grad, Entry Level

0+ years exp

American Regent, Inc. is a company focused on the Inspection and Packaging department, seeking an Inspection and Packaging Document Control Coordinator I. The role is responsible for managing GMP documentation and ensuring compliance with company standards while collaborating with various departments to maintain production schedules.

Health CareMedical

H1B Sponsor Likely

Responsibilities

Manages creation, revision and development of documents, including the change control process, to achieve clear, concise and accurate instructional documents

Provides editorial support and ensures quality of all document content; focuses on clarity, accuracy and consistency, while maintaining adherence to proper formats, regulatory requirements and company procedures and guidelines

Initiate and manage document reviews and revision to achieve clear, concise, and accurate instructional documents

Procure and distribute templates from Document Control for the generation of new documents

Works and collaborates cross-functionally with other departments and sites to complete tasks and overall project timelines

Identifies continuous improvement opportunities within the organization and effectively sees them through completion

Ensure all work is performed and documented in accordance with cGMP requirements and existing company policies and procedures, as well as cGMP requirements

Perform tasks with a minimal error rate

Perform any other tasks/duties as assigned by management

Qualification

Document controlGMP knowledgeMicrosoft WordMicrosoft ExcelMathematical skillsOrganizational skillsTime managementInterpersonal skillsCommunication skillsAdaptability

Required

High School Diploma or GED equivalent required

Strong computer and digital literacy including Microsoft Word and Excel products, required

Must be able to work independently, recognizing what needs to be done and accomplishing it with minimal supervision

Proven mathematical skills including addition, subtraction, multiplication, division, calculation of averages and percentages

Excellent organizational, time management, interpersonal and communication skills (oral and written)

Must be adaptable and able to switch priorities as needed

Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals

Ability to take feedback constructively and consider the viewpoints of others

Ability to work overtime as needed

Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves as required

Employee must be able to occasionally lift and/or move up to 50 pounds

Preferred

0-1 year of experience in manufacturing, inspection, packaging, document control, quality control and/or project management in a GMP setting

Company

American Regent, Inc.

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.

Founded in 1967

Shirley, New York, USA

501-1000 employees

http://www.americanregent.com/

H1B Sponsorship

American Regent, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (6)

2024 (10)

2023 (4)

2022 (5)

2021 (8)

2020 (9)