Nature and Scope
The Quality Control Technical Document Specialist 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 Control reviewers from the document's 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.
Ensure all work is performed and documented in accordance with existing company policies, procedures, Current Good Manufacturing Practices, health, and safety requirements.Plan daily workload to meet requirements.Draft Raw Material, In-Process, and Finished Product documents.Draft Instrument SOPs, Analysis SOPs, Method Validation/Transfer Protocols/Reports, Component Specifications, Risk Assessments, and Memos.Perform Bacterial Endotoxin Calculations, Finished Product Residual Solvent Calculations, Stability Sample Quantity Determinations, and Raw Material Code Requests.Stay current with various industry standards and expectations (USP monograph, ICH guidelines, FDA guidelines, EU guidelines, etc.). Coordinate with QA to perform Gap Assessments on current ARI documents against USP resources (general chapters/monographs).Review the USP monograph/manufacture Certificate of Analysis changes and implement on Quality Control Documentation system.Manage the Change Control Process for technical documents generated or revised within Quality Control by facilitating interdepartmental communication/coordination.Manage and track the status of technical documentation being drafted or undergoing revision within Quality Control.Procure and distribute templates from Document Control for the generation of new documents.Provide support as a technical documentation subject matter expert and communicate effectively with cross-functional departments to ensure timely delivery of documents.Maintain and analyze data/results in database and conduct trend analysis to perform annual product review report.Participate in projects identified.Ability to work overtime as needed.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.
Bachelor's degree in microbiology, Chemistry, Pharmaceutical Science, or related field required.1 year of pharmaceutical experience in Microbiology, Biology, 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 effectively communicate between various departments (QA, QC, DC, R&D, etc.).Ability to perform multiple activities at the same time and produce outstanding results to meet required deadlines.Excellent writing and editing skills, and a keen attention to detail.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. Physical Environment and Requirements Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. Employee must be able to occasionally lift and/or move up to 25 pounds.
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.
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