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.
Nature and Scope
The R&D Document Coordinator I will author, edit, review, evaluate, and maintain GMP documentation (RM documents, FP documents, Analysis SOPs, Validation Protocols, Technical reports, etc. and all required revisions). The individual will co-ordinate with Document Control and Change Request reviewers from the documents initiation to the approval stage.
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.
• Draft Raw Material, In-Process, and Finished Product documents.
• Draft Analysis SOPs, Method Validation Protocols/Reports.
• Review USP monograph changes and implement on the R&D Documentation system.
• Review Technical Reports for data transcription, accuracy and consistency.
• Provide support for Out-of-Specification and Exception/Deviation reports.
• Provide editorial support and ensure quality of all document content; focus on clarity, accuracy and consistency, while maintaining adherence to proper formats, regulatory requirements and company procedures and guidelines.
• Utilize Change Control system for creation of new documents/document revisions.
• Initiate and manage document reviews and revision to achieve clear, concise and accurate instructional documents.
• Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP requirements.
• 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.
• B.S. degree in Chemistry, Pharmaceutical Science or related field required.
• 0-1 years of pharmaceutical experience in a chemical testing, laboratory setting with a working knowledge of chemistry and instrumental analysis techniques, method development and validations preferred.
• Expertise in authoring scientific documents in a pharmaceutical environment
• Ability to digest complicated technical subject matter and work with incomplete information in a fast-paced, continually changing environment
• Ability to perform multiple activities at the same time and producing outstanding results to meet required deadlines.
• Excellent writing and editing skills, and a keen attention to detail.
• Develops and maintains expertise through interaction with subject matter experts.
• Excellent organizational, interpersonal and communication skills (oral and written).
• Proficient in Microsoft Office applications.
• Takes initiative with minimal supervision.
• Ability to identify, manage, negotiate and resolve issues independently.
• Ability to work overtime as needed.
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.