Nature and ScopeThe Manufacturing Documentation Control Specialist will author, edit, review, evaluate, and maintain GMP documentation (Manufacturing SOPs, Manufacturing Batch records, etc).
The individual will co-ordinate with Document Control and Change Request reviewers from the documents initiation to the approval stage.
The Documentation Control Specialist must have: Experience in authoring/revising documents in a pharmaceutical environment, ability to digest complicated technical subject matter and work with incomplete information in a fast-paced, continually changing environment and ability to effectively communicate between various departments (QA, QC, DC, etc.)Essential Duties and ResponsibilitiesDraft and revise SOP’s and manufacturing batch records.Provide editorial support and ensure quality of all document content; focus on clarity, accuracy and consistency, while maintaining adherence to proper formats, regulatory requirement and company procedures and guidelines.Manage the Change Control process for documents generated or revised within Manufacturing.Initiate and manage document reviews and revision to achieve clear, concise and accurate instructional documents.Manage and track the status of documents being drafted or undergoing revision within Manufacturing.Procure and distribute templates from Document Control for the generation of new 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 QualificationsHigh School Diploma or GED equivalent required.
Associates or Bachelor’s Degree with technical writing preferred.Experience with the fundamentals of document management and the management of the document life cycleAbility 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.Ability to work overtime as needed Physical Environment and RequirementsPhysically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves.
PPE is essential for the health and safety of employees.
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.American Regent Inc.
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