QA Pharma Compliance Documentation Coordinator – Nutrition and Health

Job Listing No: 9740000

QA Pharma Compliance Documentation Coordinator – Nutrition and Health

This individual will be a part of a team which will implement, support and maintain pharmaceutical cGMP???s and the Quality Management System at the Madison site as needed to assure the compliance of products produced by DuPont with all internal, customer and regulatory requirements. This position reports directly to the QA Manufacturing Lead -Pharma Project Manager and has no direct supervisory responsibility.ESSENTIAL DUTIES AND RESPONSIBILITIESThe essential functions of this position include, but are not limited to, the following: Establish and maintain site-wide documentation management system and related procedures that allow the site to capture, store, retrieve, share, update and destroy records and documents (both electronic and hard-copy paper records)Acts as back up to the QA Pharma Compliance Specialist in regards to:Review and approval of validation documentationReview and release of batch records (both production and QC)Prepare or update Master Manufacturing Records, circulate for approval, and ensure version control.Issue controlled Production Batch Records and QC Batch Records.Responsible for the Management of Change records and associated logs.Prepare and record changes to official documents or other content and confirm changes are compliant with site standards and quality systems requirements and certifications.Support review and assess Out-Of-Tolerance (OOT) reports in regards to product quality.Perform department internal audits for compliance to internal and external requirements.Ensure adherence to DuPont???s Quality and Environmental Policies and Procedures.Comply with all Company policies including maintaining a drug free work place.Support an environment of continuous improvement within the assigned area and develop awareness for product and production quality.Qualifications:Must possess a minimum of a high school diploma; Additional work-related or education experience (preferred)Knowledge of administrative and clerical procedures and document control systems, managing files and records, design/use/manipulation of Excel spreadsheets and Word forms, and the use/manipulation of databases.Demonstrated computer skills required; proficiency with Microsoft Excel and Word. Experience with document control software desired, but not required.Must have high attention-to-detail; being exact in completion of repeat activities; follows and supports documented proceduresMust have the ability to work as an active team member, as well as independently.Must have good communication skills (both verbal and written).Experience working in a pharmaceutical manufacturing facility and/or experience in an ISO 9001/GFSI certified environment (preferred).

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