Medegen Medical Products · 1 day ago
6102 - FS QC - DRWS - Sr. Document Reviewer
10301 Commerce Pkwy, Miramar, FL 33025, USA
Full-time
Onsite
Mid, Senior Level
4+ years expMedegen Medical Products is seeking a Senior Document Reviewer to conduct final audits of Batch Manufacturing Records and Packaging Records. This role involves ensuring compliance with company regulations and cGMPs while maintaining accurate records and performing document control functions associated with Quality Control Assurance.
Health CareManufacturingMedical
Responsibilities
Review executed batch records according to production schedules, Standard Operating Procedures (SOP's) and current Good Manufacturing Practices (cGMP's)
Assist with master records creation and approval
Maintain quality systems documentation, change control, investigation, deviations and procedures, and related records per established processes, procedures and standards
Issue and track controlled documents per established Company procedures and systems
Coordinate and ensure timely and accurate document flow process, including initiating routing process, revision and approval
Ensure all documented records and documentation are compliant with established rules, regulations, protocol, cGMP's and all other applicable standards
Keep trending analysis for the error encounter during the batch record review and present to the affected departments
Perform data retrieval, data analysis and reporting via use of information management systems and or quality management systems to report to head of department
Assist or perform internal audits activities, responsible for ensuring the execution of corrective actions, and for ongoing compliance with the Internal Audit program
Responsible to comply with all our food safety and food quality programs, procedures, and policies or its references. Member of the HACCP team, if required
Qualification
Required
BS/BA in life sciences or other closely related discipline or HS Diploma and four minimum years of related experience
Minimum of four years of practical document control experience in a nutraceutical or pharmaceutical environment or working knowledge of nutraceutical/pharmaceutical process
Working knowledge of pharmaceutical/nutraceutical documentation processes and techniques, including but no limited to good working knowledge of PC software and Word processing in a business environment, good knowledge of math, excellent grammar/English/proof reading skills, good written and oral communication skills, high degree of organizational skills and attention to detail
Intermediate Microsoft Excel skills (data entry, filtering, basic formulas)
Strong organizational, communication, and problem-solving skills
Ability to multitask while maintaining a high level of accuracy and attention to detail
Ability to work efficiently and effectively in a fast-paced manufacturing environment
Capable of effectively managing job-related stress and fostering productive workplace interactions
Ensure consistent, dependable attendance and demonstrate flexibility to accommodate non-standard work hours as necessary
Company
Medegen Medical Products
Medegen Medical Products is a Medical Products Manufacturer, based in Gallaway, TN and Clarksburg WV.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Denny Guest Jr
Vice President National Accounts, Strategic Partner Development
Recent News
Medical Product Outsourcing
2025-04-21
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